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Add-on home-centred activity-based therapy versus conventional physiotherapy in improving walking ability at 6-months in children with diplegic cerebral palsy: a randomized controlled trial [with consumer summary] |
Goswami JN, Sankhyan N, Singhi P |
Indian Pediatrics 2021 Sep;58(9):826-832 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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 to 12 yrs) with spastic diplegic CP (Gross Motor Function Classification System scores II to 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 up/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 to 9) m and 3 (-7.8 to 6.3) m. CONCLUSION: Adjunct home-centered activity-based therapy was safe and feasible, but did not result in appreciable gains over 6 months. CLINICAL TRIAL REGISTRATION: Number NCT02412007.
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