. Author manuscript; available in PMC: 2022 Aug 26.

Published in final edited form as: Dev Med Child Neurol. 2021 Apr 6;63(7):771–784. doi: 10.1111/dmcn.14855

Table 2:

Relevant study details from the randomized controlled trials not included in the systematic reviews

Study	Participants and inclusion criteria	Intervention/control or comparison	Child outcome measures	Results
Morgan et al.³⁹	n=30; intervention group, n=15 (53% male; median age=15.7wks at enrollment); control group, n=15 (60% male; median age=20.1wks at enrollment) Inclusion criteria: corrected age 3–4mo+absent fidgety on GMA; or 5–6mo with CP diagnosis; or abnormal neuroimaging	GAME (216h)/standard care (164h)	PDMS-2, COPM, BSID-III, GMFM-66	Significant between-group differences in favor of GAME on PDMS-2 raw scores but not Total Motor Quotient at 16wks. Both significantly higher for GAME at 12mo as were GMFM-66, BSID-III, and COPM satisfaction scores. No group differences between doses
Eliasson et al.⁵¹	n=37; intervention group, n=19 (44.4% male; median age=34wks at enrollment); control group, n=18 (61.5% male; median age=34wks at enrollment) Inclusion criteria: corrected age 3–8mo+≥15% difference between hands-on HAI; high risk of unilateral CP (known event affecting the brain and/or clinical signs, e.g. from AIMS or HINE)	Baby-CIMT (30min/6d/wks/12wks); massage (5–30min/6d/wks/12wks)	HAI, AHA	Affected hand score improved more for baby-CIMT group with high effect size. Other hand score improved with no significant group difference. Both hand score improved by 10 HAI units (median) for baby-CIMT, 0 for massage, but difference was not significant. Dose/adherence less in control group
Stark et al.⁵³	n=24; group A=12 (50% male, median age=18.6mo at enrollment); group B=12 (58.3% male, median age=19.4mo at enrollment) Inclusion criteria: corrected age 12–24mo with or highly suspected CP diagnosis and in GMFCS levels II–IV	Home-based sWBV (T0–T1), no sWBV (T1–T2)/no sWBV (T0–T2), sWBV (T1–T2). Ten 9-min sessions per week. All had standard care	GMFM-66, PEDI, BSID-II	No significant differences between with and without sWBV at T1 or between early and late onset of sWBV at T2
Chamudot et al.⁵²	n=33; intervention group, n=17 (47% male; median corrected age=11.4mo); control group, n=16 (69% male; median corrected age=10.9mo) Inclusion criteria: spastic unilateral CP; 8–16mo (18mo at end of treatment); ability to follow simple age-appropriate instructions	Modified CIMT/bimanual; 1h play/7d/8wks in-home for both	Mini-AHA, Functional Inventory	Significantly improved hand function in both groups on Mini-AHA and Functional Inventory. No group differences
Mattern-Baxter et al.⁵⁴	n=19; group 1, n=10 (30% male; median age=20.4mo); group 2, n=9 (44.4% male; median age=20.7mo) Inclusion criteria: (1) high risk of spastic CP; (2) <3y; (3) in GMFCS levels I and II; and (4) signs of walking readiness	Low-intensity treadmill training (2×/week/6wks)/ high-intensity treadmill training (10×/week/6wks); up to 20min per session; (low:183min; high:782min)	GMFM-D&E, PDMS-2, PEDI	No significant difference between groups, although both improved significantly at each time point
Hielkema et al.⁵⁵	n=43; intervention group, n=23 (65.2% male; median gestational age=32wks); control group, n=20 (55% male; median gestational age=29wks) Inclusion criteria: (1) cystic periventricular leukomalacia; (2) parenchymal lesions as the result of infarction or hemorrhage; (3) severe asphyxia with brain lesions on magnetic resonance imaging; (4) clinical dysfunction suspicious for development of CP	COPCA/typical infant physical therapy for 1y; once per week. Mean of 3.0 COPCA and 2.5 TIP (6 more sessions in COPCA)	IMP, AIMS, TINE, BSID-II, GMFM-66, CBCL	Neuromotor, cognitive, and behavioral outcomes between groups not significantly different at all time points

GMA, General Movement Assessment; CP, cerebral palsy; GAME, Goals-Activity-Motor Enrichment; PDMS-2, Peabody Developmental Motor Scale, Second Edition; COPM, Canadian Occupational Performance Measure; BSID-III, Bayley Scales of Infant and Toddler Development, Third Edition; GMFM-66, Gross Motor Function Measure-66 items; AIMS, Alberta Infant Motor Scale; HINE, Hammersmith Infant Neurological Examination; CIMT, constraint-induced movement therapy; HAI, Hand Assessment of Infants; AHA, Assisting Hand Assessment; GMFCS, Gross Motor Function Classification System; sWBV, side-alternating, whole-body vibration; PEDI, Pediatric Evaluation of Development Inventory; BSID-II, Bayley Scales of Infant and Toddler Development, Second Edition; COPCA, Coping with and Caring for infant with special needs; TIP, traditional infant physical therapy; IMP, Infant Motor Profile; TINE, Touwen Infant Neurological Examination; CBCL, Child Behavior Checklist.