REACH: Randomised comparison trial of rehabilitation early for congenital hemiplegia

Abstract

Objective: This study compared efficacy of modified constraint-induced movement therapy (Baby-mCIMT) to bimanual therapy (Baby-BIM) on upper limb outcomes for infants at high risk of unilateral cerebral palsy (CP). We hypothesised that Baby-mCIMT would improve unimanual and bimanual hand use on the Hand Assessment for Infants (HAI) to a greater extent than Baby-BIM at 12-15 months corrected age (CA). Design: Single-blind randomised controlled trial. Method: Infants included had high risk of unilateral CP with (i) asymmetric brain lesion, (ii) absent fidgety movements at 12-14 weeks post term age (PTA) or suboptimal Hammersmith Infant Neurological Examination (HINE) at <39 weeks PTA, (iii) asymmetric upper limb reach and grasp on HAI >3 points. Infants were recruited from six sites. After baseline assessments, infants were stratified by age at entry (3-4, 5-6, 7-9 months CA), sex, side of brain lesion and randomised using concealed allocation. Both interventions comprised 6-9 home visits and 6-9 telehealth sessions aimed at coaching caregivers to implement the intervention with their infant. The HAI was completed at baseline and immediately post intervention (12-15 months CA). Between group differences were analysed using linear regression, adjusting for baseline and within groups using paired t-tests. Results: Ninety-six infants (51 male; 52 right hemiplegia; mean gestational age 35 (SD 5.3) weeks PTA) at entry were randomised to Baby-mCIMT (n = 46) or Baby-BIM (n = 50). Ten infants withdrew or were lost to follow-up (Baby-mCIMT = 2; Baby-BIM = 8). There were no differences between groups immediately post intervention on HAI units (MD 2.2, 95% CI -3.4,7.8; P = 0.4) or HAI raw score for the impaired arm (MD 1.0, 95% CI -0.9,2.9; P = 0.3). Both groups demonstrated significant improvements in HAI Units for Baby-BIM (MD 13.9, 95% CI 10.2,17.6; P < 0.001) and for Baby-mCIMT (MD 15.9, 95% CI 11.7,20.1; P < 0.001). At study exit, 14 infants (7 each group) did not receive a diagnosis of CP and 8 (2 Baby-mCIMT; 6 Baby-BIM) had bilateral CP. A sensitivity analysis of 64 infants with unilateral CP found consistent results to the full dataset. Infants who entered the study between 3-6 months CA compared to >7 months CA had significantly greater gains in HAI units (MD 8.1,95% CI 1.0,15.6; P = 0.03). Conclusion: Baby-mCIMT and Baby-BIM had no between group differences however achieved similar within group differences in improving unimanual and bimanual hand use in infants at high risk of unilateral CP. Our results suggest that infants commencing intervention <7 months CA may achieve greater improvements in hand function from Baby-BIM and Baby-mCIMT confirming that intervention needs to commence in the first months of life.L6381699002022-06-10 <br />