Orthotic shorts for improving gait and walking in multiple sclerosis: a feasibility study

Figures & data

Figure 1. Image of orthotic shorts.

Front image of orthotic shorts on a mannequin. Shorts cover waist to mid-thigh. Red baselayer visible at front of abdomen and around groin area. Two additional panels are black. One panel goes around the back of the pelvis and is visible at both sides of the pelvis. The second panel is visible wrapping around the front of the thighs.

Figure 2. Overview of study design.

Flow chart of progression through the study. First box describes Visit 1 in which participants consented, were interviewed and measured for shorts. Second Box describes shorts fitting at participants’ homes. Flow chart then divides into two groups, one for each order in which the shorts were assessed. Five further visits are described in these boxes summarising the testing and home visit for each pair of shorts followed by the final assessment.

Table 1. The component constructs of the Theoretical Framework of Acceptability [13].

Component construct	Definition
Affective attitude	How an individual feels about the intervention
Burden	The perceived amount of effort that is required to participate in the intervention
Ethicality	The extent to which the intervention has a good fit with an individual’s value system
Intervention coherence	The extent to which the participant understands the intervention and how it works
Opportunity costs	The extent to which benefits, profits or values must be given up to engage in the intervention
Perceived effectiveness	The extent to which the intervention is perceived as likely to achieve its purpose
Self-efficacy	The participant’s confidence that they can perform the behaviour(s) required to participate in the intervention

Table 2. Overview of participant characteristics.

Pseudonym	Age	Gender	Disease type	Time since diagnosis (years)
Alison	36	Female	Relapsing-remitting	18
Ben	45	Male	Relapsing-remitting	10
Caroline	42	Female	Relapsing-remitting	20
Dawn	50	Female	Primary progressive	4
Erica	50	Female	Relapsing-remitting	12
Frank	46	Male	Relapsing-remitting	6
Gwen	50	Female	Relapsing-remitting	29
Helen	57	Female	Secondary progressive	20
Ingrid	56	Female	Relapsing-remitting	5
Jon	51	Male	Primary progressive	3
Kathy	52	Female	Relapsing-remitting	4
Linda	44	Female	Secondary progressive	15
Melissa	34	Female	Secondary progressive	8
Natalie	52	Female	Relapsing-remitting	5
Oliver	51	Male	Relapsing-remitting	24

Table 3. “No shorts” values at Visits 3, 5, and 7 for spatiotemporal gait parameters that improved during the study.

Outcome measure	No shorts conditions at Visit 3	No shorts conditions at Visit 5	No shorts conditions at Visit 7
Gait speed at self-selected walking speed (m/s)	1.13 ± 0.37	1.17 ± 0.31	1.2 ± 0.34
Step width variability SD (cm)	3.4 ± 1.5	3.2 ± 1.9	3.3 ± 1.8
Stride time variability SD (ms)	Median (IQR) 36 (23)	Median (IQR) 29 (18)	Median (IQR) 23 (28)
Step width variability CV (% of mean)	33 ± 19	29 ± 14	28 ± 14
Stride time variability CV (% of mean)	Median (IQR) 3.5 (1.6)	Median (IQR) 3.1 (1.4)	Median (IQR) 2.3 (2.1)

Table 4. Impact of shorts on self-selected gait speed and spatiotemporal gait parameters.

	Orthotic shorts vs. no shorts				Baselayer shorts vs. no shorts				Orthotic shorts vs. baselayer shorts
	n	Orthotic shorts	No shorts	Effect size	n	Baselayer shorts	No shorts	Effect size	n	Orthotic shorts	Baselayer shorts	Effect size
Self-selected gait speed (m/s)	15	1.2 ± 0.35	1.11 ± 0.33	0.27	15	1.12 ± 0.32	1.09 ± 0.33	0.09	14	1.2 ± 0.35	1.12 ± 0.32	0.13
Step length (cm)	15	61 ± 10	59 ± 10	0.27	15	59 ± 10	58 ± 11	0.11	14	61 ± 10	61 ± 9	0.04
Step width (cm)	15	10.7 ± 2.4	12.2 ± 3.4	−0.50	15	10.9 ± 3.5	10.8 ± 3.6	0.03	14	10.7 ± 2.4	11.2 ± 3.4	−0.20
Stride time (s)	15	1.06 ± 0.2	1.10 ± 0.2	−0.22	15	1.10 ± 0.2	1.11 ± 0.2	−0.03	14	1.06 ± 0.2	1.07 ± 0.1	−0.07
Step length variability (SD, cm)	15	3.4 ± 1.0	3.4 ± 0.9	−0.09	15	3.0 ± 0.6	3.3 ± 1.3	−0.32	14	3.3 ± 1.0	3.0 ± 0.7	0.31
Step width variability (SD, cm)	15	2.6 ± 1.1	3.4 ± 1.6	−0.57	15	3.0 ± 1.3	3.2 ± 1.6	−0.12	14	2.6 ± 1.2	3.1 ± 1.4	−0.36
Stride time variability (SD, ms)	15	Median (IQR) 32 (28)	Median (IQR) 39 (20)	−0.22	15	Median (IQR) 28 (14)	Median (IQR) 33 (19)	−0.09	14	Median (IQR) 29.9 (30)	Median (IQR) 28 (14)	0.09
Step length variability (CV)	15	5.65 ± 2.1	6.04 ± 2.1	−0.19	15	5.19 ± 1.4	5.94 ± 2.7	−0.35	14	5.5 ± 2.1	5.04 ± 1.3	0.28
Step width variability (CV)	15	25 ± 11	29 ± 13	−0.36	15	30 ± 14	32 ± 17	−0.16	14	25 ± 11	29 ± 14	−0.32
Stride time variability (CV)	15	Median (IQR) 3.3 (2.0)	Median (IQR) 3.6 (1.6)	−0.19	15	Median (IQR) 3.0 (1.0)	Median (IQR) 3.13 (1.5)	−0.20	14	Median (IQR) 2.9 (2.0)	Median (IQR) 2.9 (1.1)	0.08

Unless stated, values are means and standard deviations; between-shorts values differ from within-day values because between-shorts includes only individuals for whom data are available for both pairs of shorts, this excludes the participant who withdrew and Frank, who missed the orthotic shorts testing due to heat-induced fatigue.

Table 5. Impact of shorts on trunk and pelvic mediolateral sway.

	Orthotic shorts vs. no shorts				Baselayer shorts vs. no shorts				Orthotic shorts vs. baselayer shorts
	n	Orthotic shorts	No shorts	Effect size	n	Baselayer shorts	No shorts	Effect size	n	Orthotic shorts	Baselayer shorts	Effect size
ML pelvic sway range (cm)	15	5.4 ± 1.4	5.4 ± 1.7	−0.05	15	5.2 ± 1.0	5.3 ± 1.5	−0.06	14	5.4 ± 1.4	5.2 ± 1.0	0.18
ML trunk sway range (cm)	15	5.2 ± 1.4	5.4 ± 1.5	−0.14	15	5.2 ± 1.8	5.5 ± 2.1	−0.15	14	5.2 ± 1.4	4.8 ± 1.2	0.29

ML: mediolateral; values are means and standard deviations; between-shorts values differ from within-day values because between-shorts includes only individuals for whom data are available for both pairs of shorts; ML sway range: 95% range.

Table 6. Mean changes and effect sizes for participant-perceived walking ability.

	Mean score at baseline ± SD	Mean score following orthotic shorts home trial ± SD	Mean score following baselayer shorts home trial ± SD	Mean score at final visit ± SD	Comparison	Effect size
MSWS-12 %	73 ± 18	52 ± 24	55 ± 26	62 ± 22	Orthotic vs. baseline	−0.60
					Baselayer vs. baseline	−0.52
					Orthotic vs. baselayer	0.09

MSWS-12: 12-item Multiple Sclerosis Walking Scale; a lower score indicates walking is perceived to be better.

Figure 3. Mean step width compared to normal range in orthotic shorts compared to baseline and baselayer shorts. (Means for normal, non-neurologically impaired people and people with MS are provided for comparison, with 95% confidence intervals (95% CI) for means, using data obtained from Comber et al. [36]. This normal range is shaded. Orthotic shorts test data are missing for Frank, due to heat-induced fatigue during data collection).

Plot of step width for each participant. Participants are named on x-axis. Five points are plotted for each participant: three show step width for the baseline tests, one step width in baselayer shorts and one step width on orthotic shorts. Normal range with 95% confidence interval is shown as a horizontal band. The plot shows the tendency for step width in orthotic shorts to be closer to or within the normal range, both for people with a narrower step width at baseline and those with a wider step width at baseline.

Table 7. Convergent coding matrix for integration of qualitative and quantitative findings.

Research question	Qualitative findings	Quantitative findings	Integration
Are orthotic shorts acceptable in PwMS?	Shorts are acceptable = a logical intervention, fitted with values, liked and perceived to be effective; disadvantages = restricted hip flexion, negatively affected self-image, minor issues with dressing and undressing for some participants.	Shorts are acceptable = kept by 75% of participants, worn for 86% of time recommended.	Convergent
Might orthotic shorts be  efficacious for improving gait?	↑ confidence in walking	Improved MSWS-12, ↑gait speed, ↑ step length, ↓ stride time, improvement over time for MSWS-12 and gait speed	Convergent
	Perceived ↑control over leg direction	↓ step width, ↓ step width variability	Convergent
	Walking further and faster	Improved MSWS-12, ↑ gait speed, ↓ stride time in orthotic shorts	Convergent
	Felt more stable, sturdy, better balance,  walking smoother and less wobbly	Improved MSWS-12 ↓ step width, ↓ step width variability, ↓ stride time variability, small ↓ in ML trunk sway	Convergent
		No change in ML pelvic sway	Divergent
	Lifting legs felt harder especially when  climbing stairs (A, B, G, H, K, L)	↑ step length, ↓stride time variability	Divergent - complementary
		Hip flexion activities not measured, e.g., steps and stairs	Silence in quantitative
		For orthotic shorts, worse MSWS-12 scores for participants B, G, and L; stairs-specific MSWS-12 question worse rating for G, H, and L.	Convergent

Serrao M, Casali C, Ranavolo A, et al. Use of dynamic movement orthoses to improve gait stability and trunk control in ataxic patients. Eur J Phys Rehabil Med. 2017;53(5):735–743.

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Comber L, Sosnoff J, Galvin R, et al. Postural control deficits in people with multiple sclerosis: a systematic review and meta-analysis. Gait Posture. 2018;61:445–452. 2018

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Data availability statement

http://doi.org/10.17032/shu-180028.