Add-on Home-Centered Activity-Based Therapy vs Conventional Physiotherapy in Improving Walking Ability at 6-Months in Children With Diplegic Cerebral Palsy: A Randomized Controlled Trial.

Background: : Institutional physiotherapy as a standard of care for management of cerebral palsy (CP) has certain shortcomings, especially in resource-constrained settings. This is a proof-of-concept trial to evaluate the efficacy of individualized home-centered activity-based therapy in children with spastic diplegic CP.

Design: Randomized controlled trial (open-label).

Settings: Tertiary-care hospital with pediatric neurology services (July, 2014 to July, 2016).

Participants: Consecutive sample of 59 children (5-12 y) with spastic diplegic CP (Gross Motor Function Classification System scores II-III) without fixed lower-limb contractures, illnesses impeding physiotherapy or history of recent botulinum toxin injection/surgery were recruited.

Procedure: Children were randomized to Intervention or Control arms. Their 6-minute-walk Test (6MWT) scoring and clinical examination were performed at baseline, 3 and 6 months. Children in Intervention arm (n=30) were prescribed parent-supervised home-centered activity-based therapy (walking, standing, squatting, climbing upstairs/downstairs, kicking a ball, dancing, riding a tricycle/bicycle) in addition to their institutional physiotherapy. Children in Control arm (n=29) were prescribed ongoing institutional physiotherapy alone. Logbooks, home videos and telephonic follow-ups were used to ensure compliance.

Main Outcome Measures: Comparison of the mean change in 6MWT scores at 6 months (from baseline) between the two groups.

Results: Median (IQR) change in 6MWT scores at 6 months (from baseline) in the Intervention and Control arms were 3.5 (-5.3, 9) m and 3 (-7.8, 6.3) m.

Conclusions: Adjunct home-centered activity-based therapy was safe and feasible, but did not result in appreciable gains over 6 months.