Clinical outcome measures to evaluate the effects of orthotic management post-stroke: a systematic review

Figures & data

Table 1. Eligibility criteria for included studies.

Study characteristic	Inclusion	Exclusion
Population	• Studies including adults aged 18 years or older who have had a stroke	• Studies including other pathological groups in which results for participants who have had a stroke cannot be identified
Intervention	• Lower limb orthotic devices including foot orthoses, ankle foot orthoses, knee orthoses, knee-ankle-foot orthoses or functional electrical stimulation (FES)	• Studies describing development of new orthotic designs • Studies in which orthoses were only used during therapy sessions • Studies investigating robotic assisted gait training
Control intervention	• No orthotic device • Another design of orthotic device
Outcomes	• Clinical outcome measures	• Outcome measures that are not readily available in the clinical setting
Publication language	• English	• All other languages
Study design	• Randomised controlled trials • Cohort studies • Case series • Case-control • Qualitative studies	• Case reports
Publication type	• Any publication reporting primary data	• Publications not reporting primary data, or only available as abstracts

Figure 1. PRISMA diagram depicting the flow of information through different phases of the review.

Table 2. Summary of articles included in the systematic review.

Reference	Test conditions/Intervention C = condition G = group	Aim	Total participants (drop outs)	Male/ female	Age (mean or median)	Post onset (months)	Testing occasions (T)	Clinical outcome measures
Barrett et al. [39]	Repeated measures C1/No FES (treatment onset) C2/No FES (18 weeks treatment) C3/FES (18 weeks treatment)	Evaluate the impact of the Odstock Dropped Foot Stimulator on the percieved quality of life and gait speed of individuals with post-stroke hemiplegia and multiple sclerosis	21 (1)	15/6	62	50.4	T1/baseline T2/week 18	10MWT Psychosocial Impact of Assistive Devices Scale (PIADS) - measured only at 18 weeks.
Beckerman et al. [40]	Randomised groups G1/Thermocoagulation of tibial nerve (TH)+AFO (polyprop) G2/PlaceboTH + AFO (polyprop) G3/TH + PlaceboAFO G4/PlaceboTH + PlaceboAFO	Evaluate the impact of tibial nerve blocking using percutaneous radiofrequency thermocoagulation and AFOs on the walking ability and speed of individuals with post-stroke hemiplegia.	60 (3)	43/17	58	34	T1/baseline T2/week 12	Sickness Impact Profile (SIP) (ambulation category) walking speed (5.5 m)
Beckerman et al. [41]	Randomised groups G1/(TH)+AFO G2/PlaceboTH + AFO G3/TH + PlaceboAFO G4/PlaceboTH + PlaceboAFO	Evaluate the impact of tibial nerve blocking using percutaneous radiofrequency thermocoagulation and AFOs on the spasticity observed in the affected lower limb in individuals with post-stroke hemiplegia	60 (3)	43/17	58	34	T1/baseline T2/12 weeks	Spasticity muscle tone ankle clonus achilles tendon reflex Ankle ROM Fugl-Meyer assessment
Bethoux et al, [42]	Randomised groups G1/FES (WalkAide) G2/AFO (varied design)	Compare changes in gait and quality of life with the use of either FES or an AFO in individuals with post-stroke heimplegia	495 (156)	304/191	63.9	82.8	T1/baseline T2/week 26	10MWT Stroke Impact Scale Device related serious adverse event (SAEs) rate 6MWT Modified Emory Functional Ambulation profile Bergs balance scale Timed up and Go Stroke specific QoL
Bethoux et al. [43]	Randomised groups G1/FES (WalkAide) G2/AFO (varied design)	Compare changes in the gait quality and function observed in individuals with post-stroke hemiplegia with the use of either FES or an AFO	495 (111)	304/191	63.9	82.8	T1/baseline T2/week 52	10MWT Device related serious adverse event (SAEs) rate 6MWT Modified Emory Functional Ambulation profile
Bouchalova et al. [44]	Repeated measures C1/no AFO C2/Maramed AFO C3/Y-tech AFO	Investigate the influence of no orthosis, prefabricated orthosis and custom orthosis on spatiotemporal gait paremeters and functional balance in stroke patients	15(0)	12/3	59.4	16.7	T1/after 1 day familiarization	TUG Step Test (affected) Step Test (unaffected) Four Square Step Test
Cakar et al. [45]	Repeated measures C1/No AFO C2/AFO (prefab post leaf spring)	Evaluate the effect of prefabricated thermoplastic posterior leaf spring AFOs on balance and fall risk in individuals with post-stroke hemiplegia	25 (0)	17/8	60.5	20.3	T1/1 week after AFO provision	BBS note – remaining tests performed on an instrumented system
Chen et al. [46]	Repeated measures C1/No AFO C2/AFO (anterior shell)	Evaluate the effect of anterior AFOs on functional mobility in individuals with post-stroke hemiplegia	21 (0)	11/10	58.2	25.3	T1/time post AFO provision not clear	TUG Timed up and down stairs (TUDS)
de Séze et al. [47]	Randomised groups G1/AFO (prefab. polyprop) G2/AFO (chignon orthosis)	Evaluate the comparative efficacy of a prefabricated polypropylene AFO and a Chignon AFO on mobility in patients with post-stroke hemiplegia	28 (5)	18/10	54.5	2.6	T1/baseline T2/week 4 T3/week 12	10MWT Motricity index (MI) Functional ambulation classification (FAC) Postural assessment structural scal (PASS) Functional independence measure (FIM) Spasticity Wear time per day Patients’ tolerance VAS
de Wit et al. [48]	Repeated measures C1/no AFO C2/AFO (varied designs)	Evalaute the impact of AFOs on gait speed, dynamic balance and self-confidence among individuals with post-stroke hemiplegia	20	12/8	61.2	25.6	T1/minimum 20 months post AFO provision	10MWT TUG Stairs test Self-confidence Self-rated difficulty of task
DeMeyer et al. [49]	Randomised groups G1/No device G2/Custom bivalve cast G3/Prefab orthosis (Healwell Soft Ease Multi AFO)	Evaluate the effects observed with the nocturnal use of bivalve casts and pressure-relieving AFOs on passive ankle range of motion in individuals with hemiplegia associated with stroke or traumatic brain injury	46 (1)	27/19	65	0.3	T1/baseline (admission) T2/discharge (custom = week 27; PAFO = week 34)	ROM/Ankle dorsiflexion Spasticity (Ashworth) FIM
Ding et al. [50]	Randomised groups G1/conventional therapy + training G2/same as G1 + botulinum toxin G3/same as G2 + AFO (static or dynamic)	Evaluate the impact of botulinum toxin type A injections and AFOs on lower limb spasticity, mobility, balance and independence in individuals with post-stroke hemiplegia.	103	49/54	63.5	16.2 (unit not reported)	T1/baseline T2/week 4 T3/week 12 T4/week 26	Spasticity (Clinic spasticitty Influx-CSI) Fugl-Meyer Assessment (FMA) BBS FIM
Do et al. [51]	Repeated measures C1/Plastic AFO (jointed, 3 mm polyprop with PF stop C2/Hybrid AFO (jointed, 1.5 mm polyprop and canvas , PF stop)	Evaluate the comparative efficacy of traditional polypropylene AFOs and a hybrid AFO made with ploypropylene and fabric on individuals with post-stroke hemiplegia with respect to patient satisfaction, device wieght, gait speed and associated kinematic variables	17 (0)	13/4	55.8	46.1	T1/2 weeks after AFO provision (all instructed to use both AFOs at least 3 hrs/day)	Self-reported satisfaction (questionnaire designed for study) Weight of AFO
Doğğan et al. [52]	Repeated measures C1/No AFO C2/AFO (articulated, PF stop)	Evaluate the impact of articulated AFOs with plantarflexion stops on balance and mobility in post-stroke hemiplegia.	51	24/27	60.7	2.3	T1/approx. 4 days after AFO provision	Ashburn walking test (15 m) Ashburn stair test (7 stairs) TUG BBS STREAM (mobility)
Embrey et al. [53]	Randomised groups G1/No FES (T1) followed by FES (T2) G2/FES (T1) followed by no FES (TS)	Evaluate the impact of FES on gait speed and functional mobility among individuals with post-stroke hemiplegia	28 (5)	16/12	60	58.8	T1/week 12 T2/week 26	6MWT Emory Functional Ambulation Profile Stroke impact scale (SIS) Spasticity (Modified Ashworth) Muscle strength
Erel et al. [35]	Randomised groups G1/shoes only G2/AFO (dynamic)	Evaluate the impact of dynamic AFOs on measures of gait speed, dynamic balance and metabolic efficiency in individuals with post-stroke hemiplegia	32 (4)	18/10	46.5	27.8	T1/baseline (G2 test without AFO) T2/week 12 (G2 tested with AFO	Functional reach, TUG Timed up stairs Timed down stairs Velocity (100 m walk) PCI
Everaert et al. [54]	Randomised groups G1/phase 1 6 weeks FES(WalkAide), phase 2 6 weeks AFO G2/phase 1 6 weeks AFO,phase 2 6 weeks FES G3/phase 1 6 weeks AFO, phase 2 6 weeks AFO	Evaluate the comparative efficacy of the WalkAide FES unit and AFOs with regard to gait speed, metabolic efficienies, perceived safety and device preference in individuals with post-stroke hemiplegia	121 (28)	67/26	57	6.4	T1/baseline T2/week 3 T3/week 6 T4/week 9 T5/week 12	Velocity PCI Figure 8 walking test 10MWT Mobility index Perceived safety Adverse Events
Farmani et al. [55]	Repeated measures C1/shoe only C2/AFO (prefabricated solid) C3/AFO (prefabricated solid) with rocker	Evaluate the comparative efficacy of standard shoes, a prefabricated AFO with standard shoes and a prefabricated AFO used with a rocker bar shoe modification on the gait speed and dynamic balance observed in individuals with post-stroke hemiplegia	15	10/5	54.23	22.1	not clear	10MWT TUG
Farmani et al. [56]	Randomised groups G1/AFO (prefabricated solid) with standard shoes (SS) G2/AFO (prefabricated solid) rocker sole shoes (RS)	Evaluate the comparative efficacy of standard shoes, a prefabricated AFO with standard shoes and a prefabricated AFO used with a rocker bar shoe modification on the gait speed and dynamic balance observed in individuals with post-stroke hemiplegia	30	19/11	59.3	29.1	not clear	TUG Timed up stairs Timed down stairs Velocity over 10 m
Granat et al. [57]	Repeated measures C1/No FES C2/FES	Evaluate the efficacy of a peroneal stimulator on gait speed, symmetry, and foot and ankle position in patients with post-stroke hemiplegia.	19 (3)	16/3	55	7	T1/baseline T2/week 4 (control period) T3/week 8 (test period)	Barthel index Velocity (6 or 10 m)
Grissom & Blanton [58]	Repeated measures C1/No AFO C2/AFO (imobilising/adjustable)	Evaluate the impact of an adjustable AFO in the treatment of plantarflexion contractures in individuals with hemiplegia associated with stroke or traumatic brain injury	6 (1)	2/4	43.8	Not reported	T1/baseline T2/2 weeks after AFO provision	Dorsiflexion ROM - Goniometer
Hale et al. [59]	Repeated measures C1/no AFO C2/AFO (ground reaction)	Evaluate the impact of an advanced ground reaction AFO on gait speed, gait endurance and balance in individuals with post-stroke hemiplegia.	5 (0)	2/3	56	25.4	T1/baseline T2/1-3 days after AFO provision	10MWT TUG 6MWT
Hung et al. [60]	Repeated measures C1/No AFO C2/AFO (anterior shell)	Evaluate the impact of customized low temperature plastic anterior leaf spring AFOs on the functional walking ability of individual with post-stroke hemiplegia	52 (0)	35/17	54.5	33.5	T1/21 weeks after AFO provision	mEFAP Floor Carpert TUG Obstacles Stairs 6MWT Fall Efficacy Scale
Hyun et al. [61]	Repeated measures C1/No AFO C2/AFO (custom rigid)	Evaluate the impact of AFOs on the aerobic capacity and gait endurance observed in individuals with post-stroke hemiplegia	15 (0)	8/7	62.1	1.1	not clear	6MWT
Iwata et al. [62]	2 groups with repeated measures G1a/patients without TTFR, no AFO G1b/patients without TTFR, AFO with inhibitor bar G2a/patients with tonic toe flexion reflex (TTFR), no AFO G2b/patients with TTFR, AFO with inhibitor bar	Evaluate the impact of an inhibitor bar attached to the foot plate of an AFO on the gait speed of individuals with post-stroke hemiplegia, presenting with and without tonic toe flexion reflex	18 (1)	14/3	61.8	31	T1/baseline T2/week 2 (intervention after T2) T3/week 3 T4/week 4	10MWT Spasticity (Ashworth)
Kazutoshi et al. [63]	Repeated measures C1/No intervention C2/Repetitive facilitative exercise + custom AFO (varied designs)	Evaluate the collective impact of therapeutic excercises, gait training and an AFO on the gait speed, dynamic balance and functional mobility of individuals with chronic, post-stroke hemiplegia	27 (24 male, 3 female)	24/3	59.3	35.7	T1/baseline T2/week 4	Fugl-Meyer assessment Stroke Impairment Assessment Set TUG 10MWT
Kluding et al. [64]	Randomised groups G1/FES (NESS L300; Bioness Inc, Valencia, CA)) G2/standard AFO (design unclear)	Evaluate the comparative efficacy of FES and AFOs on gait speed, gait endurance, functional mobility, measured activity, balance and satisfaction for individuals with post-stroke hemiplegia	197 (22)	118/79	61.14	54.6	T1/baseline T2/week 30	10MWT (comfortable and fast speed) Fugl-Meyer TUG 6MWT BBS Functional reach Stroke Impact Scale (SIS) =participation Step activity monitor (7 days) User satisfaction survey Adverse events
Laufer et al. [65]	Repeated measures C1/No device C2/FES (NESS L300; Bioness Inc, Valencia, CA))	Evaluate the impact of FES on gait speed and functional mobility among individuals with post-stroke hemiplegia	24 (8)	15/1	55.0	63.6	T1/Baseline (no device) T2/8 weeks after FES provision T3/52 weeks after FES provision	Stroke Impact Scale - SIS 16 SIS - participation domain 10MWT - comfy cadence only
Maeda et al. [66]	Repeated measures C1/No AFO C2/AFO (plastic)	Compare the walking velocity and walking energy cost on floor with and without a plastic AFO	18 (0)	15/3	45	19	T1/8 months after AFO provision	6-minute walk PCI
McCain et al. [67]	Repeated measures C1/no AFO C2/AFO (custom joint set to allow 3-5° dorsiflex and 8-10° plantarflexion	Evaluate the impact of a defined custom AFO design on walking endurance and motor recovery in patients with post-stroke hemiplegia	3 (0)	2/1	58	18.6	T1/baseline T2/between 11 and 131 weeks	6MWT Stroke Rehab Assessment of Movement test (STREAM)
Nikamp et al. [31]	Randomised groups G1/AFO provided 1 week post stroke G2/AFO provided 9 weeks post stroke	Evaluate the comparative efficacy of early versus delayed provision of an AFO on gait speed, gait endurance, dynamic balance, functional mobility and balance in individuals with post-stroke hemiplegia	33 (7)	20/13	57.2	1.0	T1/baseline T2/biweekly for 17 weeks T3/week 26.	BBS Functional Ambulation Categories 6MWT 10MWT TUG Stairs test Rivermead Mobility Index Barthel Index Motricity index
Nolan et al. [68]	Repeated measures C1/no AFO C2/AFO (design not clear) G1 = ambulation index 1-2 G2 = ambulation index 3-4 G3 = ambulation index 5	Evaluate the impact of AFOs on gait speed and endurance in individuals with post-stroke hemiplegia	18 (0)	14/4	53.1	54.9	not clear	6MWT 25 feet walk
O’Dell et al. [69]	Repeated measures C1/no FES C2/FES (Bioness L300; Bioness Inc, Valencia, CA)	Evaluate the longitudinal impact of FES on gait speed on individuals with post-stroke hemiplegia and identify predictive variables for increased responsiveness to FES	99 (30)	51/48	60.7	57.6	T1/baseline (no FES & with FES) T2/6 weeks (with FES) T3/12 weeks (with FES) T4/30 weeks (no FES & with FES) T5/36 weeks (with FES) T6/42 weeks (with FES)	10MWT
Ota et al. [28]	G1/KAFO G2/AFO	Identify the preferential factor of ADL disabilities for selecting KAFOs or AFOs. Investigate the characteristics of ADL disabilities in inpatients prescribed with KAFOs or AFOs	442 (0)	262/ 180	69	1.2	T1/1 week post admission	FIM
Ota et al. [29]	G1/KAFO G2/AFO	To investigate differences in independent mobility from admission to discharge in people with subacute stroke with KAFOs and AFOs	381 (0)	215/ 166	71	1.2	T1/1 week post admission T2/discharge	FIM
Ota et al. [30]	Repeated measures C1/no KAFO C2/KAFO	Evaluate early effects of a KAFO on static standing balance in people with subacute stroke	29	15/14	66	0.9	T1/not clear	Standing balance feet apart eyes open Standing balance feet apart eyes closed Standing balance feet together eyes open Standing balance tandom stance eyes open
Pardo et al. [70]	Repeated measures C1/no AFO C2/custom AFO (patients’ own custom) C3/prefab AFO (hinged; Orthomerica, Newpot Beach, CA)	Evaluate the comparative efficacy of custom molded and prefabricated articulated AFOs on spatiotemporal gait parameters, weight bearing symmetry and dynamic balance in individuals with post-stroke hemiplegia	14 (0)	9/5	55.7	13.5	T1/same day testing, accomodation period not clear	TUG
Park et al. [71]	Repeated measures C1/no orthosis C2/anterior AFO C3/posterior AFO	Can’t find the article	17 (0)	10/7	57.7	1.2	T1/day of provision of AFOs	Berg Balance Scale
Pavlik [72]	Repeated measures C1/No AFO C2/AFO (custom polypropylene jointed or rigid)	Evaluate the impact of AFOs on gait speed and dynamic balance among individuals with post-stroke hemiplegia who were legacy AFO users	4 (3)	3/1	60	75	not clear	10MWT TUG Self-reported exersion (Borg Rating of perceived exertion)
Portnoy et al. [27]	Randomised groups G1/knee orthosis (hinged soft) T1; no orthosis T2 G2/no orthosis T1; knee orthosis T2	Evaluate the impact of a hinged soft knee orthoses on gait pattern, speed and endurance, as well as the static and dynamic balance of individuals with post stroke hemiplegia presenting with knee hyperextension	34 (3)	23/8	59.9	73.2	T1/baseline T2/week 4 (crossover after week 4) T3/week 8	Berg Balance scale 6MWT 10MWT Timed up and go Satisfaction questionnaire (based on OPUS)
Prenton et al. [73]	Repeated measures C1/No FES C2/FES (ShefStim)	Feasibility trial of an array-based FES system among individuals with post-stroke hemiplegia evalauting usage time, experienced problems, walking speed, kinematic gait variables and user satisfaction	10 (3)	8/2	58	Not reported	T1/baseline T2/2 weeks after fitted with FES	QUEST version 2 Self reported problems
Rao et al. [74]	Repeated measures C1/no AFO C2/AFO (varied designs)	Evaluate the impact of AFOs on the performance of the Functional Reach Test by individuals with post-stroke hemiplegia	23 (0)	11/12	60.9	7.8	not clear	Functional reach test
Salisbury et al. [75]	Randomised groups G1/AFO (prefabricated) G2/FES (ODFS, Odstock Medical Ltd. Sailsbury, UK)	Evaluation of FES on gait velocity, cadence and functional mobility among individuals with post-stroke hemiplegia during the sub-acute phase of their rehabilitation	16 (3)	3/4	54.2	2.0	T1/baseline T2/week 6 T3/week 12	10MWT Functional ambulation classification Stroke Impact scale Perception of walking (VAS scale)
Sheffler et al. [76]	Repeated measures C1/no orthosis C2/AFO (varied designs) C3/FES (ODFS, Odstock Medical Ltd. Sailsbury, UK)	Evaluate the comparative efficacy of no intervention, AFO and FES on functional mobility for individuals with post-stroke hemiplegia	14 (0)	9/5	56.7	30.8	T1/all testing took place over 2 days, accomodation period is not defined	Emory Functional Ambulation Profile (nEFAP) Subjective feedback
Sheffler et al. [77]	Randomised groups G1/No devie or AFO G2/FES (ODFS, Odstock Medical Ltd. Sailsbury, UK)	Evaluate the comparative efficacy of FES and usual care (with or without an AFO) on motor impairment, functional mobility and quality of life in individuals with post-stroke hemiplegia	110 (26)	67/43	53	44.8	T1 baseline, T2 - week 12 (end of FES use) T3 - week 24 (post teatment) T4 -week 36 (post treatment)	Fugl-Meyer Modified Functional Ambulation Profile mFAP Stroke Specific Quality of Life (SSQOL)
Shin et al. [78]	Repeated measures C1/AFO (rigid) C2/AFO (multi-joint with post stop) C3/AFO (multi.joint with Klanzak joint)	Evaluate the impact of a multi-joint AFL on gait and both static and dynamic balance in individuals with post-stroke hemiplegia	15 (0)	9/6	58.5	10.5	T1/single testing occation (accomodation period with AFO not clear)	10MWT Functional reach TUG
Simons et al. [79]	Repeated measures C1/no AFO C2/AFO (varied designs)	Evaluate the impact of AFOs on static and dynamic balance, weight bearing symmetry, gait velocity and functional mobility in individuals with unilateral hemiplegia	20 (0)	14/6	57.2	39.3	T1/minimum 2 months post AFO provision	BBS TUG 10MWT FAC Timed Balance test
Street et al. [80]	Repeated measures C1/No FES C2/FES (ODFS PACE, Odstock Medical Ltd, Sailsbury, UK)	Evaluate both the orthotic effect and therapeutic (or training) effect of FES on gait speed and functional mobility in individuals with post-stroke hemiplegia	133 (9)	53/80	59	32.4	T1/baseline T2/20 weeks (tested with and without FES)	10MWT Functional ambulation category (FAC) Step counter (only 35 users included)
Suat et al. [36]	Repeated measures C1/shoes only C2/DAFO (custom)	Evaluate the impact of dynamic AFOs on dynamic weight bearing symmetry, temporospatial gait considerations, and measures of static balance, dynamic balance, and metobolic efficiency in individuals with post-stroke hemiplegia	14 (2)	11/3	42.5	30.2	T1/baseline T2/minimum of 3 months post DAFO provision	Functional reach TUG timed down stairs Timed up stairs PCI 100m walk test
Taylor et al. [24]	Repeated measures C1/No FES C2/FES (ODFS, Odstock Medical Ltd, Sailsbury, UK)	Evaluate the impact of FES on gait speed and physiologic cost index in individuals with post-stroke hemiplegia	111 (9)	Not reported	55.4	64.8	T1 - baseline T2 − 4.5 months post FES provision	10MWT PCI
Tyson et al. [81]	Repeated measures C1/no AFO C2/AFO (custom polypropylene, hinged, dorsiflexion stop)	Evaluate the impact of a hinged AFO on temporospatial gait variables and functional mobility in individuals with post-stroke hemiplegia	25 (0)	16/9	49.9	8.3	T1/1 month	FAC 5m walk velocity Paper walkway – stride length – step length self-reported opinion
van Swigchem et al. [82]	Repeated measures C1/AFO (polypropylene, design not clear) C2/FES (NESS L300,	Evaluate the transition from an AFO to FES on gait speed, measured activity level and satisfaction among individuals with post-stroke hemiplegia	26 (2)	21/5	52.8	38	T1/baseline (AFO) T2/2 weeks (AFO and FEs) T3/8 weeks (AFO and FES)	10MWT Activity monitor Self-reported satisfaction
Wang et al. [83]	Repeated measures C1/no AFO C2/AFO (design not clear)	Evaluate the impact of AFOs on static and dynamic balance as well as gait speed and cadence in individuals with both sub-acute and chrnoic post-stroke hemiplegia	42 (0)	23/19	61.1	Group 1 − 101 group 2 − 1043	T1/single testing occation (accomodation period with AFO not clear)	BBS 10MWT
Zissimopoulos et al. [84]	C1/no AFO C2/AFO (non-rigid)	Evaluate the impact of an AFO on balance confidence in individuals with post-stroke hemiplegia who were legacy AFO users	15	7/8	55	144	T1/AFO or no AFO (accomodation period with AFO not clear) T2/Condition not tested at T1	ABC

ABC: Activities-Specific Balance confidence Scale; BBS: Berg Balance Scale; CMSAM: Chedoke-McMaster Stroke Assessment Measure; EFAP: Emory Functional ambulation profile; FAC: Functional ambulation categories; FES: Functional Electrical Stimulation; FIM: Functional Independence Measure; mEFAP: Modified Emory Functional ambulation profile; PCI: Physiological cost index; PIADS: Psychosocial Impact of Assistive Devices Scale; ROM: range of motion; SAS: Scandinavian stroke scale; SIAS: Stroke Impairment Assessment Set; SIS: Stroke Impact Scale; SAEs: serious adverse events; STREAM: Stroke rehabilitation Assessment of movement test; TUDS: Timed up and down stairs; TUG: Timed Up and Go; QUEST: Quebec user evaluation of satisfaction with assistive technology; 6MWT: 6-minute walk test; 10MWT: 10-meter walk test

Figure 2. Network analysis. Circles (nodes) represent each outcome measure, the larger the circle the more publications that used this specific measure. Lines represent outcomes measures which appear together in the same article, the thicker the line the more times the measures are used together. The more central the nodes are placed, the more coupling they have with other nodes. fim: Functional Independence Measure; rom: range of motion; mefap: Modified Emory Functional Ambulation Profile; stroke specific: stroke specific quality of life; sis: Stroke Impact Scale; saes: serious adverse events; 6mwt: 6-minute Walk Test; 10mwt: 10-minute Walk Test; bbs: Berg Balance Scale; tug: timed up and go; pci: Physiological Cost Index; Tuds: timed up and down stairs; self-reported: self-report satisfaction; fac: functional ambulation categories).

Table 3. Summary of statistical analysis and effect size for each outcome measure.

Outcome measure	Reference	Orthosis v/s no (within groups)			Orthoses over time (within groups)		Orthosis design 1 vs Orthosis design 2 (within subjects)		Orthosis design 1 vs Orthosis design 2 (between groups)		Early provision versus delayed provision (between groups)
6-minute-walk test	Bethoux et al., 2014 [42]				G1 *  G2 #				#
	Bethoux et al., 2015 [43]				G1*	G2 #			#
	Embrey et al., 2010 [53]
	Hale et al., 2013 [59]
	Hung et al., 2010 [60]	*
	Hyun et al., 2015 [61]	*
	Kluding et al., 2013 [64]								#
	Maeda et al., 2009 [66]	*
	McCain et al., 2012 [67]
	Nikamp et al., 2017 [31]
	Nolan et al., 2009 [68]	G1* G2 ** G3 **
	Portnoy et al., 2015 [27]	*
10-meter walk test	Barrett and Tayler, 2010 [39]
	Bethoux et al., 2014 [42]				G1** G2***				#
	Bethoux et al., 2015 [43]				G1** G2***				#
	de Seze et al., 2011 [47]
	de Wit et al., 2004 [48]	*
	Everaert et al., 2013 [54]
	Farmani et al., 2015 [55]	C1 vs C2 *** C1 vs C3 ****					C2 vs C3*
	Farmani et al., 2016 [56]						G1 #	G2 *	*
	Hale et al., 2013 [59]
	Iwata et al., 2003 [62]						G1 #	G2 *
	Kazutoshi et al., 2017 [63]				**
	Kluding et al., 2013 [64]
	Laufer et al., 2009 [65]				****
	Nikamp et al., 2017 [31]
	O'Dell et al., 2014 [69]				T1 to T4**; T1 to T6 ***
	Pavlik, 2008 [72]	**
	Portnoy et al., 2015 [27]	#
	Salisbury et al., 2013 [75]
	Shin et al., 2017 [78]						C1 vs c2* C1 vs C3**
	Simons et al., 2009 [79]	**
	Street et al., 2017 [80]				C1	C2
	Taylor et al., 1999 [24]	*			C1 * C2 *		T2 C1 vs C2*
	Van Swigchem et al., 2010 [82]				T2 vs T3* T2 vs T3***		T3 C1 vs C2*
	Wang et al., 2005 [83]	*
25ft walk	Nolan et al., 2009 [68]
Figure 8 walking test	Everaert et al., 2013 [54]
Walking velocity	Granat et al., 1996 [57]
Walking velocity (5 or 5.5m)	Beckerman et al., 1996 [40]
	Tyson et al., 2001 [81]	**
Walking velocity(100m)	Erel et al., 2011 [35]								**
	Suat et al., 2011 [36]	*			#
TUG	Bethoux et al., 2014 [42]				#				#
	Bouchalova et al., 2016 [44]	C1 vs C2 # C1 vs C3*
	Chen et al., 2014 [46]	*
	de Wit et al., 2004 [48]	*
	Doǧǧan et al., 2011 [52]	*
	Erel et al., 2011 [35]								*
	Farmani et al., 2015 [55]	C1 vs C2** C1 vs C3 ****					C2 vs C3**
	Farmani et al., 2016 [56]						G1 –	G2*	*
	Hale et al., 2013 [59]
	Kazutoshi et al., 2017 [63]				**
	Kluding et al., 2013 [64]
	Nikamp et al., 2017 [31]
	Pardo et al., 2015 [70]	*					#
	Pavlik, 2008 [72]	#
	Portnoy et al., 2015 [27]	#
	Sheffler et al., 2013 [77]						#
	Shin et al., 2017 [78]						C1 vs C2 #	C1 vs C3*
	Simons et al., 2009 [79]	**
	Suat et al., 2011 [36]	#			#
Ashburn walking test (15 m)	Doǧǧan et al., 2011 [52]	#
Ashburn stair test (7 stairs)	Doǧǧan et al., 2011 [52]	#
Timed up and down stairs (TUDS)	Chen et al., 2014 [46]	*
	de Wit et al., 2014 [48]	*
	Erel et al., 2011 [35]								up*	down*
	Farmani et al., 2016 [56]						up G1# ; G2* down G1# ; G2#		up* down ^#
	Nikamp et al., 2017 [31]
	Suat et al., 2011 [36]	#			#
Step test	Bouchalova et al., 2016 [44]	C1 vs C2 * C1 vs C3 #
BBS	Bethoux et al., 2014 [42]				G1*	G2 #			#
	Cakar et al., 2010 [45]	**
	Ding et al., 2015 [50]				****				G1 vs G3**** G2 vs G3**
	Doǧǧan et al., 2011 [52]	**
	Kluding et al., 2013 [64]
	Nikamp et al., 2017 [31]
	Park et al., 2009 [71]	C1 vs C2 * C1 vs C3 *					C2 vs C3*
	Portnoy et al., 2015 [27]	*
	Simons et al., 2009 [79]	*
	Wang et al., 2005 [83]
ABC	Zissimopoulos et al., 2014 [84]	*
Timed balance	Simons et al., 2017 [79]	**
	Ota et al., 2019 [30]
Falls Efficacy Scale	Hung et al., 2011 [60]	**
Postural assessment scale (PASS)	de Séze et al., 2011 [47]
mEFAP	Bethoux et al., 2014 [42]				G1 #	G2 #			#
	Bethoux et al., 2015 [43]				G1 #	G2 #			#
	Embrey et al., 2010 [53]
	Hung et al., 2011 [60]	*
STREAM (mobility)	Doǧǧan et al., 2011 [52]	***
	McCain et al., 2012 [67]
Four square step test	Bouchalova et al., 2016 [44]	C1 vs C2* C1 vs C3 -
Functional reach	Erel et al., 2011 [35]
	Kluding et al., 2013 [64]
	Rao et al., 2016 [74]	Forward reach **** left/right reach ***
	Shin et al., 2017 [78]						C1 vs C2** C1 vs C3 ***
	Suat et al., 2011 [36]	*			-
FIM	de Seze et al., 2011 [47]
	DeMeyer et al., 2015 [49]								-
	Ding et al., 2015 [50]				All groups ****				****
	Ota et al., 2018a [28]								****
	Ota et al., 2018b [29]				G1 *** G2 ****				T1 *** T2 ***
PCI	Erel et al., 2011 [35]								***
	Evaraert et al., 2013 [54]				After T3	After T5			After T3	After T5
	Maeda et al., 2009 [66]	*
	Suat et al., 2011 [36]	****			*
	Taylor et al., 1999 [24]	#			C1 T1 vs T2 * C2 T1 vs T2 –
SIS-16	Bethoux et al., 2014 [2]				G1 #	G2 #
	Embrey et al., 2010 [53]
	Laufer et al., 2009 [65]				***
	Kluding et al., 2013 [64]
	Salisbury et al., 2013 [75]
SIS-Participation	Laufer et al., 2009 [65]				***
Stroke Impairment Assessment set	Kazutoshi et al., 2017 [63]				***
Stroke Rehab Assessment of movement test	McCain et al., 2012 [67]
Sickness impact profile (ambulation category)	Beckerman et al., 1996 [41]
Fugl-Meyer Assessment	Beckerman et al., 1996 [41]
	Ding et al., 2015 [50]				G1 * G2# G4****				****
	Kazutoshi et al., 2017 [63]				**
	Kluding et al., 2013 [64]
	Sheffler et al., 2013 [77]
ROM	Beckerman et al., 1996 [40]
	DeMeyer et al., 2015 [49]								#
	Grissom and Blanton, 2001 [58]				****
Spasticity	Beckerman et al., 1996 [41]
Spasticity (clinic spasticity Influx)	Ding et al., 2015 [50]				****				****
Spasticity (Ashworth)	de Seze et al., 2011 [47]
	DeMeyer et al., 2015 [49]
	Embrey et al., 2010 [53]
	Iwata et al., 2003 [62]
Muscle tone	Beckerman et al., 1996 [41]
Achilles tendon reflex	Beckerman et al., 1996 [41]
Ankle clonus	Beckerman et al., 1996 [41]
Device related serious adverse events	Bethoux et al., 2014 [42]
	Bethoux et al., 2015 [43]
	Everaert et al., (2013) [54]
	Kluding et al., 2013 [64]
	Prenton et al., 2014 [73]
Emory	Bethoux et al., 2014 [42]				G1 #	G2 #			#
Functional	Bethoux et al., 2015 [43]				G1 #	G2 #			#
Ambulation profile (total score)	Salisbury et al., 2013 [75]								#
	Sheffler et al., 2006 [76]	floor	C1/C2*	C1/C3#			Floor* Carpet# Obstacle# Stairs#
		carpet	C1/C2*	C1/C3*
		obstacle	C1/C2*	C1/C3*
		stair	C1/C2*	C1/C3#
	Sheffler et al., 2013 [77]
	Street et al., 2017 [80]
Stroke specific	Bethoux et al., 2014 [42]				#				#
QoL	Sheffler et al., 2013 [77]				T1 vs T2 and T4	T1 vs T3
Psychosocial Impact of Assistive Devices Scale (PIADS)	Barrett and Taylor, 2010 [39]
Satisfaction (self-report)	Do et al., 2014 [51]						***
	Kluding et al., 2013 [64]
	Portnoy et al., 2015 [27]
	Prenton et al., 2014 [73]
	Tyson et al., 2001 [81]
	Van Swigchem et al., 2010 [82]
Perceived safety/self confidence	de Wit et al., 2004 [48]	*
	Everaert et al., (2013) [55]								After T3	After T5
FAC	de Séze et al., (2011) [47]
	Nikamp et al., 2017 [31]
	Simons et al., 2009 [79]	***
	Street et al., 2017 [80]
	Tyson et al., 2001 [81]
Barthel index	Granat et al., 1996 [57]
	Nikamp et al., 2017 [31]
Step activity monitor	Kluding et al., 2013 [64]
	Street et al., 2017 [80]
	Van Swigchem et al., 2010 [82]						#
Rivermead Mobility Index	Nikamp et al., 2017 [31]
Borg Rating of Perceived Exertion	Pavlik, 2008 [72]

Light grey shading indicates a statistically significant difference within or between groups, dark grey indicates no significant difference and black indicates that no statistical analysis was reported. Interpretation of effect size [71] # d < 0.2 (trivial); * 0.2–0.49 (small); ** 0.5–0.79 = (moderate); *** 0.8–1.29 (large); ****>1.3 (very large). If no effect size is indicated in the table, it was not able to be calculated on the basis of data provided in the article.

If multiple analyses were preformed and level of significance or effect size differed, this has been indicated by shading cells or including a letter to reflect the analysis performed T: analysis across or within specific time points; G: analysis within or between different groups; C: analysis within or between different conditions.

Table 4. Coding of outcome measures according to ICF.

	Chapter	ICF code	ICF label	Outcome measure linked to code
Body Functions	b1 – Mental functions	b110	Consciousness functions	SAS
		b114	Orientation functions	SAS
		b126	Temperament and personality functions	Stroke Specific QoL Scale
		b144	Memory functions	FIM
				Stroke Specific QoL Scale
		b156	Perceptual functions	SAIS
		b164	Problem solving	FIM
		b167	Mental functions of language	SAIS
	b2 – Sensory functions and pain	b270	Sensory functions related to temperature and other stimuli	Fugl-Meyer Assessment
				SAIS
		b280	Sensation of pain	Fugl-Meyer Assessment
				CMSAM
	b4 – Functions of the cardiovascular, haematological, immunological and respiratory systems	b455	Exercise tolerance functions	Borg Rating of Perceived Exertion
				6-minute Walk Test
				Step counter/activity monitor
				Stroke Specific QoL Scale
	b5 – Functions of the digestive, metabolic and endocrine systems	b525	Defecation functions	Barthel Index
				FIM
				SIS-16
		b610	Urinary excretory functions	Barthel Index
				FIM
				SIS-16
		b540	General metabolic functions	PCI
	b7 – Neuromusculoskeletal and movement-related functions	b710	Mobility of joint functions	Fugl-Meyer Assessment
				STREAM
				ROM
				SAIS
		b730	Muscle power functions	CMSAM
				SAIS
				SAS
		b735	Muscle tone functions	SAIS
				Ashworth Scale
				Composite Spasticity Index
				Muscle tone
				Ankle clonus
		b750	Motor reflex functions	Fugl-Meyer Assessment
				Achilles tendon reflex
		b760	Control of voluntary movement functions	Fugl-Meyer Assessment
				STREAM
				CMSAM
				SAS
		b765	Involuntary movement functions	Fugl-Meyer Assessment
		b780	Sensations related to muscles and movement functions	Fugl-Meyer Assessment
Activities And Participation	d3 – Communication	d310	Communicating with – receiving – spoken messages	FIM
		d330	Speaking	FIM
				Stroke Specific QoL Scale
	d4 – Mobility	d415	Maintaining a body position	STREAM
				CMSAM
				SAIS
				Berg Balance Scale
				Brunnel Balance assessment
				Timed Balance Test
				Rivermead Mobility Index
				Postural Assessment Scale
				SIS-16
		d410	Changing basic body position	STREAM
				CMSAM
				Max. step length
				Berg balance scale
				Brunnel Balance assessment
				Rivermead Mobility Index
				mEFAP
				EFAP
				Falls Efficacy Scale
				Four Square Step Test
				Functional Reach Test
				Stroke Specific QoL scale
		d420	Transferring oneself	CMSAM
				Berg Balance Scale
				Barthel Index
				FIM
				Rivermead Mobility Index
				Falls Efficacy Scale
				SIS-16
		d450	Walking	STREAM
				CMSAM
				Paper walkway (tempro-spatial gait data)
				SAS
				ABC
				Brunnel Balance assessment
				Barthel Index
				6-minute Walk Test
				FIM
				FAC
				Rivermead Mobility Index
				Timed up and go
				10 m walk test
				25 feet walk
				Walking velocity(100m)
				Walking velocity
				Walking velocity 5 m
				Walking velocity (5.5 m)
				Figure 8 walking test
				Perry Ambulation Category
				mEFAP
				EFAP
				Falls Efficacy Scale
				Step Counter/Activity Monitor
				Sickness Impact Profile (ambulation category)
				Stroke Specific QoL scale
				SIS-16
		d455	Moving around	CMSAM
				ABC
				Barthel Index
				FIM
				FAC
Rivermead Mobility Index
Perry Ambulation category
mEFAP
EFAP
Step test
Ashburn Walking and Stairs Test
Timed up and down stairs
Sickness Impact Profile (ambulation category)
Stroke Specific QoL Scale
SIS-16
d460	Moving around in different locations	CMSAM
		ABC
		Rivermead Mobility Index
		Perry Ambulation Category
		mEFAP
		EFAP
			SIS-16 – Stroke Impact Scale-16
d5 – Self care	d510	Washing oneself	Barthel Index
			FIM
			Falls efficacy Scale
			Stroke Specific QoL Scale
			SIS-16
	d520	Caring for body parts	Barthel Index
			FIM
	d530	Toileting	Barthel Index
			FIM
			Stroke Specific QoL Scale
			SIS-16 – Stroke Impact Scale-16
	d540	Dressing	FIM
			Falls Efficacy Scale
			Stroke Specific QoL Scale
			SIS-16 – Stroke Impact Scale-16
	d550	Eating	Barthel Index
			FIM
			Stroke Specific QoL Scale
d6 – Domestic life	d630	Preparing meals	Falls efficacy scale
			Stroke Specific QoL Scale
	d640	Doing housework	ABC
			SIS-16 – Stroke Impact Scale-16
d7 – Interpersonal interactions and relationships	d710	Basic interpersonal interactions	FIM
			Stroke Specific QoL Scale
	d760	Family relationships	Stroke Specific QoL Scale
d8 – Major life areas	d850/d855	Remunerative employment/non-remunerative employment	SIS – participation
d9 – Community, social and civic life	d910	Community life	SIS – participation
		d920	Recreation and leisure	SIS – participation
Environmental factors	e1 – Products and technology	e120	Products and technology for personal indoor and outdoor mobility and transportation	PIADS
				Device related serious adverse event rate
				QUEST
				Self-reported problems with orthosis
		e150	Design, construction and building products and technology of buildings for public use	ABC
Personal factors	Personal factors	Not coded in ICF		Falls Efficacy Scale
				ABC
				PIADS
				Stroke Specific QoL scale
				Self-report satisfaction
				Self confidence
				Perceived safety
				VAS perception of walking

Barrett C, Taylor P. The effects of the odstock drop foot stimulator on perceived quality of life for people with stroke and multiple sclerosis. Neuromodulation. 2010;13(1):58–64.

 PubMed Web of Science ®Google Scholar

Beckerman H, Becher J, Lankhorst GJ, et al. Walking ability of stroke patients: efficacy of tibial nerve blocking and a polypropylene ankle-foot orthosis. Arch Phys Med Rehabil. 1996;77(11):1144–1151.

 PubMed Web of Science ®Google Scholar

Beckerman H, Becher J, Lankhorst GJ, et al. The efficacy of thermocoagulation of the tibial nerve and a polypropylene ankle-foot orthosis on spasticity of the leg in stroke patients: results of a randomized clinical trial. Clin Rehabil. 1996;10(2):112–120.

 Google Scholar

Bethoux F, Rogers H, Nolan K, et al. The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2014;28(7):688–697.

 PubMed Web of Science ®Google Scholar

Bethoux F, Rogers H, Nolan K, et al. Long-term follow-up to a randomized controlled trial comparing peroneal nerve functional electrical stimulation to an ankle foot orthosis for patients with chronic stroke. Neurorehabil Neural Repair. 2015;29(10):911–922.

 PubMed Web of Science ®Google Scholar

Bouchalova V, Houben ELS, Tancsik D, et al. The influence of an ankle-foot orthosis on the spatiotemporal gait parameters and functional balance in chronic stroke patients. J Phys Ther Sci. 2016;28(5):1621–1628.

 PubMedGoogle Scholar

Cakar E, Durmus O, Tekin L, et al. The ankle-foot orthosis improves balance and reduces fall risk of chronic spastic hemiparetic patients. Eur J Phys Rehabil Med. 2010;46:363–368.

 PubMed Web of Science ®Google Scholar

Chen CL, Teng YL, Lou SZ, et al. Effects of an anterior ankle-foot orthosis on walking mobility in stroke patients: get up and go and stair walking. Arch Phys Med Rehabil. 2014;95(11):2167–2171.

 PubMed Web of Science ®Google Scholar

de Sèze MP, Bonhomme C, Daviet JC, et al. Effect of early compensation of distal motor deficiency by the Chignon ankle-foot orthosis on gait in hemiplegic patients: a randomized pilot study. Clin Rehabil. 2011;25(11):989–998.

 PubMed Web of Science ®Google Scholar

de Wit D, Buurke J, Nijlant J, et al. The effect of an ankle-foot orthosis on walking ability in chronic stroke patients: a randomized controlled trial. Clin Rehabil. 2004;18(5):550–557.

 PubMed Web of Science ®Google Scholar

DeMeyer L, Brown M, Adams A. Effectiveness of a night positioning programme on ankle range of motion in patients after hemiparesis: a prospective randomized controlled pilot study. J Rehabil Med. 2015;47(9):873–877.

 PubMed Web of Science ®Google Scholar

Ding XD, Zhang GB, Chen HX, et al. Color Doppler ultrasound-guided botulinum toxin type a injection combined with an ankle foot brace for treating lower limb spasticity after a stroke. Eur Rev Med Pharmacol Sci. 2015;19:406–411.

 PubMed Web of Science ®Google Scholar

Do KH, Song JC, Kim JH, et al. Effect of a hybrid ankle foot orthosis made of polypropylene and fabric in chronic hemiparetic stroke patients. Am J Phys Med Rehabil. 2014;93:130–137.

 PubMed Web of Science ®Google Scholar

Doğan A, Mengüllüoğlu M, Özgirgin N. Evaluation of the effect of ankle-foot orthosis use on balance and mobility in hemiparetic stroke patients. Disabil Rehabil. 2011;33(15–16):1433–1439.

 PubMed Web of Science ®Google Scholar

Embrey DG, Holtz SL, Alon G, et al. Functional electrical stimulation to dorsiflexors and plantar flexors during gait to improve walking in adults with chronic hemiplegia. Arch Phys Med Rehabil. 2010;91(5):687–696.

 PubMed Web of Science ®Google Scholar

Erel S, Uygur F, Şimşek IE, et al. The effects of dynamic ankle-foot orthoses in chronic stroke patients at three-month follow-up: a randomized controlled trial. Clin Rehabil. 2011;25(6):515–523.

 PubMed Web of Science ®Google Scholar

Everaert D, Stein R, Abrams G, et al. Effect of a foot-drop stimulator and ankle-foot orthosis on walking performance after stroke: a multicenter randomized controlled trial. Neurorehabil Neural Repair. 2013;27(7):579–591.

 PubMed Web of Science ®Google Scholar

Farmani FM-B, Pei MA, et al. The effect of rocker bar ankle foot orthosis on functional mobility in post-stroke hemiplegic patients. Iranian Rehabil J. 2015;13(3):109–112.

 Google Scholar

Farmani F, Mohseni Bandpei MA, Bahramizadeh M, et al. The effect of different shoes on functional mobility and energy expenditure in post-stroke hemiplegic patients using ankle-foot orthosis. Prosthet Orthot Int. 2016;40(5):591–597.

 PubMed Web of Science ®Google Scholar

Granat MH, Maxwell DJ, Ferguson ACB, et al. Peroneal stimulator: evaluation for the correction of spastic drop foot in hemiplegia. Arch Phys Med Rehabil. 1996;77(1):19–24.

 PubMed Web of Science ®Google Scholar

Grissom SP, Blanton S. Treatment of upper motoneuron plantarflexion contractures by using an adjustable ankle-foot orthosis. Arch Phys Med Rehabil. 2001;82(2):270–273.

 PubMed Web of Science ®Google Scholar

Hale J, Seale J, Jennings J, et al. An advanced ground reaction design ankle-foot orthosis to improve gait and balance in individuals with post-stroke hemiparesis: a case series. J Prosthet Orthot. 2013;25(1):42–47.

 Google Scholar

Hung JW, Chen PC, Yu MY, et al. Long-term effect of an anterior ankle-foot orthosis on functional walking ability of chronic stroke patients. Am J Phys Med Rehabil. 2011;90:8–16.

 PubMed Web of Science ®Google Scholar

Hyun CW, Kim BR, Han EY, et al. Use of an ankle-foot orthosis improves aerobic capacity in subacute hemiparetic stroke patients. PM R. 2015;7(3):264–269.

 PubMedGoogle Scholar

Iwata M, Kondo I, Sato Y, et al. An ankle-foot orthosis with inhibitor bar: effect on hemiplegic gait. Arch Phys Med Rehabil. 2003;84(6):924–927.

 PubMed Web of Science ®Google Scholar

Kazutoshi T, Shuji M, Keiko I, et al. Short-term effects of physiotherapy combining repetitive facilitation exercises and orthotic treatment in chronic post-stroke patients. J Phys Ther Sci. 2017;29:212–215.

 PubMedGoogle Scholar

Kluding PM, Dunning K, O’Dell MW, et al. Foot drop stimulation versus ankle foot orthosis after stroke: 30-week outcomes. Stroke. 2013;44(6):1660–1669.

 PubMed Web of Science ®Google Scholar

Laufer Y, Hausdorff JM, Ring H. Effects of a foot drop neuroprosthesis on functional abilities, social participation, and gait velocity. Am J Phys Med Rehabil. 2009;88(1):14–20.

 PubMed Web of Science ®Google Scholar

Maeda N, Kato J, Azuma Y, et al. Energy expenditure and walking ability in stroke patients: their improvement by ankle-foot orthoses. IES. 2009;17(2):57–62.

 Google Scholar

McCain KJ, Smith PS, Querry R. Ankle-foot orthosis selection to facilitate gait recovery in adults after stroke: a case series. J Prosthet Orthot. 2012;24(3):111–123.

 Google Scholar

Nikamp CDM, Buurke JH, van der Palen J, et al. Six-month effects of early or delayed provision of an ankle-foot orthosis in patients with (sub)acute stroke: a randomized controlled trial. Clin Rehabil. 2017;31(12):1616–1624.

 PubMed Web of Science ®Google Scholar

Nolan KJ, Savalia KK, Lequerica AH, et al. Objective assessment of functional ambulation in adults with hemiplegia using ankle foot orthotics after stroke. PM R. 2009;1(6):524–529.

 PubMedGoogle Scholar

O’Dell MW, Dunning K, Kluding P, et al. Response and prediction of improvement in gait speed from functional electrical stimulation in persons with poststroke drop foot. PM R. 2014;6(7):587–601.

 PubMedGoogle Scholar

Ota T, Hashidate H, Shimizu N, et al. Differences in activities of daily living between people with subacute stroke who received knee-ankle-foot and ankle-foot orthoses at admission. J Phys Ther Sci. 2018a;30(10):1245–1250.

 PubMedGoogle Scholar

Ota T, Hashidate H, Shimizu N, et al. Difference in independent mobility improvement from admission to discharge between subacute stroke patients using knee-ankle-foot and those using ankle-foot orthoses. J Phys Ther Sci. 2018b;30(8):1003–1008.

 PubMedGoogle Scholar

Ota T, Hashidate H, Shimizu N, et al. Early effects of a knee-ankle-foot orthosis on static standing balance in people with subacute stroke. J Phys Ther Sci. 2019;31(2):127–131.

 PubMedGoogle Scholar

Pardo V, Galen S, Gahimer JE, et al. Effects of custom-molded and prefabricated hinged ankle-foot orthoses on gait parameters and functional mobility in adults with hemiplegia: a preliminary report. J Prosthet Orthot. 2015;27(1):33–38.

 Google Scholar

Park JH, Chun MH, Ahn JS, et al. Comparison of gait analysis between anterior and posterior ankle foot orthosis in hemiplegic patients. Am J Phys Med Rehabil. 2009;88(8):630–634.

 PubMed Web of Science ®Google Scholar

Pavlik AJ. The effect of long-term ankle-foot orthosis use on gait in the poststroke population. J Prosthet Orthot. 2008;20:49–52.

 Google Scholar

Portnoy S, Frechtel A, Raveh E, et al. Prevention of genu recurvatum in poststroke patients using a hinged soft knee orthosis. PM R. 2015;7(10):1042–1051.

 PubMedGoogle Scholar

Prenton S, Kenney LP, Stapleton C, et al. Feasibility study of a take-home array-based functional electrical stimulation system with automated setup for current functional electrical stimulation users with foot-drop. Arch Phys Med Rehabil. 2014;95(10):1870–1877.

 PubMed Web of Science ®Google Scholar

Rao N, Aruin AS. Role of ankle foot orthoses in functional stability of individuals with stroke. Disabil Rehabil Assist Tech. 2016;11(7):595–598.

 PubMed Web of Science ®Google Scholar

Salisbury L, Shiels J, Todd I, et al. A feasibility study to investigate the clinical application of functional electrical stimulation (FES), for dropped foot, during the sub-acute phase of stroke - A randomized controlled trial. Physiother Theory Pract. 2013;29(1):31–40.

 PubMed Web of Science ®Google Scholar

Sheffler L, Hennessey M, Naples G, et al. Peroneal nerve stimulation versus an ankle foot orthosis for correction of footdrop in stroke: impact on functional ambulation. Neurorehabil Neural Repair. 2006;20(3):355–360.

 PubMed Web of Science ®Google Scholar

Sheffler LR, Taylor PN, Gunzler DD, et al. Randomized controlled trial of surface peroneal nerve stimulation for motor relearning in lower limb hemiparesis. Arch Phys Med Rehabil. 2013;94(6):1007–1014.

 PubMed Web of Science ®Google Scholar

Shin Y, Lee D, Kim M. The effect of newly designed multi joint ankle foot orthosis on the gait and dynamic balance of stroke patients with foot drop. J Phys Ther Sci. 2017;29(11):1899–1902.

 PubMedGoogle Scholar

Simons C, Asseldonk E, Kooij H, et al. Ankle-foot orthoses in stroke: effects on functional balance, weight-bearing asymmetry and the contribution of each lower limb to balance control. Clin Biomech. 2009;24(9):769–775.

 PubMed Web of Science ®Google Scholar

Street T, Swain I, Taylor P. Training and orthotic effects related to functional electrical stimulation of the peroneal nerve in stroke. J Rehabil Med. 2017;49(2):113–119.

 PubMed Web of Science ®Google Scholar

Suat E, Fatma U, Nilgun B. The effects of dynamic ankle-foot orthoses on functional ambulation activities, weight bearing and spatio-temporal characteristics of hemiparetic gait. Disabil Rehabil. 2011;33(25–26):2605–2611.

 PubMed Web of Science ®Google Scholar

Taylor P, Burridge J, Dunkerley A, et al. Clinical audit of 5 years provision of the Odstock dropped foot stimulator. Artif Organs. 1999;23(5):440–442.

 PubMed Web of Science ®Google Scholar

Tyson SF, Thornton HA. The effect of a hinged ankle foot orthosis on hemiplegic gait: objective measures and users’ opinions. Clin Rehabil. 2001;15(1):53–58.

 PubMed Web of Science ®Google Scholar

van Swigchem R, Vloothuis J, den Boer J, et al. Is transcutaneous peroneal stimulation beneficial to patients with chronic stroke using an ankle-foot orthosis? A within-subjects study of patients’ satisfaction, walking speed and physical activity level. J Rehabil Med. 2010;42(2):117–121.

 PubMed Web of Science ®Google Scholar

Wang R, Yen L, Lee C, et al. Effects of an ankle-foot orthosis on balance performance in patients with hemiparesis of different durations. Clin Rehabil. 2005;19(1):37–44.

 PubMed Web of Science ®Google Scholar

Zissimopoulos A, Fatone S, Gard S. The effect of ankle-foot orthoses on self-reported balance confidence in persons with chronic poststroke hemiplegia. Prosthet Orthot Int. 2014;38(2):148–154.

 PubMed Web of Science ®Google Scholar

Lindsay MP, Norrving B, Sacco RL, et al. World Stroke Organization (WSO): Global Stroke Fact Sheet 2019. Int J Stroke. 2019;14(8):806–817.

 PubMed Web of Science ®Google Scholar