Vibration Therapy as an Early Intervention for Children Aged 2–4 Years with Cerebral Palsy: A Feasibility Study

Figures & data

Figure 1. CONSORT diagram showing the recruitment of participants into the study.

Table 1. Demographic and clinical characteristics of participants.

n		9
Age (years)		3.6 [2.8, 4.8]
Sex	Male	4 (44%)
	Female	5 (56%)
Ethnicity	New Zealand European	6 (67%)
	Māori	2 (22%)
	Asian	1 (11%)
GMFCS level	I	3 (33%)
	II	5 (66%)
	III	1 (11%)
Type of cerebral palsy	Spastic	7 (78%)
	Dyskinetic	2 (22%)

Age data are median [quartile 1, quartile 3], while other data are n (%).

GMFCS: Gross Motor Function Classification System.

Table 2. Vibration therapy (VT) treatment protocol.

Session number	Frequency (Hz)	VT duration (min)	Sets (n)^a
1	12	1	3
2–3	15	1	3
4–5	15	2	3
6–7	16	2	3
8–9	18	2	3
10–11	18	3	3
12–14	19	3	3
15–48	20	3	3

^aParticipants were instructed to rest for 3 minutes between each VT set.

Table 3. Feasibility and acceptability data on vibration therapy sessions, and caregivers’ feedback.

Study #	Age (years)^1	GMFCS level	Referral type	Adherence^2	Reasons for missing sessions or withdrawing	Reported side effects	Biggest challenges	Overall feedback	Is HB-VT acceptable?
1	4	III	Hospital	47 (98%)	not given	none	"Heavy plate to move around"	"My child seems to be on her feet more often and better balance herself"	yes
2	2.8	I	Hospital	27 (54%)	lack of time; child’s reluctance	none	"Find time"; "to convince child to do VT and stay on plate"	"It would be better to have training in a childcare or physio"	no
3	4.8	II	Self-referral	48 (100%)	–	'tickling’ in legs lasting <30 sec after VT	"Keep enthusiasm over the session"	"My child overall is more active post vibration"	yes
4	4.8	I	Hospital	46 (96%)	lack of time	none	"To carry on a session"	"My child thinks it was fun"	yes
5	2.5	II	Hospital	48 (100%)	–	none	"To get my child amused to participate"	"Perhaps a little easier to move"	yes
6	2.5	II	Hospital	withdrew^3	lack of time (had a newborn baby)	none	"Find time and convince a child to do VT"	"It would be great to continue participation, but we had to drop due to having a newborn and lack of time"	yes
7	3.6	II	Self-referral	44 (92%)	lack of time; went away	'tickling’ in ears during VT	"Keep my child motivated"; "fitting VT in busy schedule"	"I think my child is stronger and is more balanced"	yes
8	3.0	II	Self-referral	48 (100%)	–	none	"Getting child to get on the machine"; "fitting VT into the day"	"My child possibly has more movements in the left side" ^5	yes
9	4.0	I	Hospital	withdrew^4	unknown (did not respond)	–	–	–	–
10	4.0	II	Self-referral	48 (100%)	–	none	"Find time in busy schedule"; "getting correct stance"	"Changes being noticed after the 2^nd week of treatment with improvements in gait and walking speed"	yes

HB-VT: home-based vibration therapy; VT: vibration therapy.

¹Age at baseline.

²The study protocol prescribed 48 VT sessions, and adherence (%) was calculated as: (number of sessions completed ÷ 48) x 100.

³Withdrew two weeks after starting VT.

⁴Withdrew soon after recruitment.

⁵Child’s more severely affected side.

Table 4. Functional and health-related quality of life outcomes.

Assessment	Parameter	Baseline	Control	Δ Control	Treatment	Δ Treatment	Δ Treatment vs Δ control
Motor function	n	8	8		7
	GMFM-66 (raw score)	156 ± 22	156 ± 22	4 (-2, 9)	164 ± 15	9 (4, 14)^††	5 (-5, 15)
	GMFM-66 (GMAE score)	63.1 ± 6.2	65.2 ± 9.5	2.1 (-0.7, 5.0)	68.0 ± 8.1	2.3 (-0.7, 5.4)	0.2 (-5.2, 5.6)
Mobility	n	7	7		7
	10-meter walk/run test (seconds)	5.2 ± 3.1	4.6 ± 2.0	−0.4 (-1.3, 0.5)	3.8 ± 1.6	-1.0 (-1.9, −0.1)^†	−0.6 (-1.4, 0.1)
Muscle strength	n	6	6		6
	Knee extension – strong leg (kg)	3.6 ± 1.3	4.0 ± 0.9	0.2 (-1.4, 1.8)	4.7 ± 1.5	0.9 (-0.7, 2.5)	0.6 (-0.1, 1.4)
	Knee extension – weak leg (kg)	2.8 ± 1.2	3.2 ± 1.2	0.4 (-0.1, 0.9)	3.6 ± 1.3	0.4 (-0.1, 0.9)	0.1 (-0.6, 0.8)
Balance	n	6	6		6
	Ellipse area (cm^2)	3.6 ± 1.4	5.5 ± 3.9	0.0 (-8.3, 8.4)	2.8 ± 1.5	−0.8 (-9.1, 7.5)	−0.9 (-3.4, 1.7)
PedsQL-CPM	n	9	9		8
	Daily activities	139 ± 153	167 ± 126	25 (-16, 66)	181 ± 157	7 (-38, 52)	−18 (-91, 54)
	Eating activities	261 ± 131	303 ± 96	43 (-3, 89)	300 ± 134	−6 (-57, 45)	−49 (-134, 35)
	Fatigue	278 ± 92	269 ± 73	−5 (-73, 64)	275 ± 86	−5 (-72, 62)	0 (-23, 23)
	Movement and Balance	317 ± 118	275 ± 111	−37 (-91, 17)	334 ± 121	51 (-8, 111)	89 (0, 177)*
	Pain	331 ± 86	308 ± 87	−3 (-70, 64)	291 ± 60	−15 (-81, 51)	−12 (-51, 26)

GMAE: Gross Motor Ability Estimator; GMFM: Gross Motor Function Measure; PedsQL-CPM: Pediatric Quality of Life Inventory (PedsQL™) Cerebral Palsy Module.

Data on baseline, Control, and Treatment periods are means ± standard deviations; changes from baseline (Δ) within and between study periods are the adjusted mean differences and respective 95% confidence intervals, derived from linear mixed models including as covariates the participant’s age and GMFCS level, and the value of the outcome at the start of the given period.

^†p < 0.05 and ^††p < 0.01 for the difference within a given study period and *p < 0.05 for the difference between Control and Treatment, with statistically significant Δ values (at p < 0.05) shown in bold.

Table 5. Anthropometric and body composition outcomes.

Outcome type	Parameters	Baseline	Control	Δ Control	Treatment	Δ Treatment	Δ Treatment vs Δ control
Anthropometry	n	9	9		8
	Weight z-score	0.26 ± 1.46	0.37 ± 1.14	0.07 (-0.4, 0.54)	0.59 ± 1.24	0.14 (-0.38, 0.67)	0.07 (-0.76, 0.91)
	Height z-score	−0.28 ± 1.16	−0.26 ± 1.18	0.03 (-0.14, 0.21)	−0.03 ± 1.27	0.07 (-0.12, 0.25)	0.03 (-0.21, 0.27)
	BMI z-score	0.63 ± 1.53	0.81 ± 1.18	−0.02 (-1.15, 1.11)	0.92 ± 1.31	0.17 (-0.94, 1.28)	0.19 (-0.28, 0.66)
Body composition	n	6	6		6
	Legs lean mass (kg)	3.3 ± 0.6	3.2 ± 0.7	−0.1 (-0.3, 0.2)	3.5 ± 0.6	0.3 (-0.0, 0.5)	0.3 (-0.2, 0.8)
	TBLH lean mass (kg)	10.2 ± 1.6	10.3 ± 2.1	0.0 (-0.6,0.6)	10.9 ± 1.8	0.6 (0.0, 1.2)^†	0.6 (-0.6, 1.8)
	Total fat mass (kg)	5.6 ± 1.9	5.7 ± 2.3	0.1 (-0.5, 0.7)	6.1 ± 2.6	0.4 (-0.2, 1.0)	0.3 (-0.9, 1.5)
	Total body fat (%)	30.6 ± 6.9	30.8 ± 7.1	0.2 (-0.9, 1.3)	31.0 ± 8.0	0.2 (-0.9, 1.3)	0 (-2.1, 2.1)
	Legs aBMD (g/cm^2)	0.494 ± 0.057	0.504 ± 0.056	0.010 (-0.001, 0.021)	0.525 ± 0.046	0.021 (0.010, 0.031) ^††	0.011 (-0.010, 0.032)
	TBLH aBMD (g/cm^2)	0.467 ± 0.033	0.471 ± 0.032	0.005 (-0.012, 0.022)	0.487 ± 0.033	0.015 (-0.001, 0.032)	0.01 (-0.01, 0.03)
	Legs BMC (g/cm^2)	131 ± 26	141 ± 29	10 (5, 15) ^††	151 ± 31	10 (6, 15) ^††	0 (-4, 4)
	TBLH BMC (g/cm^2)	335 ± 52	362 ± 61	27 (-1, 54)	367 ± 79	7 (-21, 34)	−20 (-54, 14)

^aBMD, areal bone mineral density; BMC, bone mineral content; BMI, body mass index; TBLH, total body less head.

Data on baseline, Control, and Treatment periods are means ± standard deviations; changes (Δ) within and between study periods are the adjusted mean differences and respective 95% confidence intervals, derived from linear mixed models including as covariates the participant’s age and Gross Motor Function Measure (GMFCS) level, and the value of the outcome at the start of the given period.

^†p < 0.05 and ^††p < 0.01 for the difference within a given study period, and the statistically significant Δ values (at p < 0.05) are shown in bold.