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A Multisite Randomized Controlled Trial of Hand Arm Bimanual Intensive Training Including Lower Extremity for
Leanne Sakzewski1, Yannick Bleyenheuft2, Iona Novak3
1Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Health, Medicine and Behavioural Sciences, The University of Queensland, Brisbane, Australia.
Objective:
To test the efficacy of Hand Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) to improve gross motor function, manual ability, goal performance, walking endurance, mobility, and self-care for children with bilateral cerebral palsy.
Study Design:
This prospective, waitlist randomized controlled trial included children with bilateral cerebral palsy, aged 6-to-16-years and classified Gross Motor Function Classification System levels II to IV. HABIT-ILE delivered for 2 weeks (65 hours) was compared with usual care. Primary outcomes postintervention were gross motor function (Gross Motor Function Measure-66) and manual ability (ABILHAND-Kids). Secondary outcomes were goal performance (Canadian Occupational Performance Measure), self-care and mobility (Pediatric Evaluation of Disability Inventory-Computer Adapted Test), bimanual hand performance (Both Hands Assessment), and walking endurance (6 Minute Walk Test). Linear regression models were used to determine between group differences, adjusted for baseline scores.
Results:
Ninety-two children were recruited; 2 were deemed ineligible after randomization and were excluded. Ninety children (HABIT-ILE n = 46, usual care n = 44), mean age 10.4 (SD 3.0) years, Gross Motor Function Classification System II = 32; III = 31; IV = 27 were included. HABIT-ILE led to superior gains in manual ability (mean difference 0.85, 95% CI 0.38-1.33; P < .001) but not gross motor function. HABIT-ILE led to superior changes on goal performance, self-care, and mobility.
Conclusions:
HABIT-ILE was effective in improving manual ability, mobility, self-care, and goal performance, but not gross motor function. Significant gains were immediately retained at 26 weeks postintervention. Large individual variability suggests further analyses need to be performed to understand characteristics of children who achieved clinically meaningful gains across outcomes.
Trial Registration:
Australian and New Zealand Clinical Trials Registry (ACTRN12618000164291).
