Jyotindra Narayan Goswami1, Naveen Sankhyan1, Pratibha Singhi2. 1. Pediatric Neurology and Neurodevelopment Unit, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India. 2. Department of Pediatrics Neurology and Neurodevelopment, Medanta, The Medicity, Gurgaon, Haryana, India. Correspondence to: Prof Pratibha Singhi, Director, Department of Pediatrics Neurology and Neurodevelopment, Medanta, The Medicity, Gurgaon, Haryana, India. doctorpratibhasinghi@gmail.com.
Abstract
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 (5-12yrs) 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 prescribedparent-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 ongoinginstitutional 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. CONCLUSION: Adjunct home-centered activity-based therapy was safe and feasible, but did not result in appreciable gains over 6 months.
RCT Entities:
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 (5-12yrs) 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 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, 9) m and 3 (-7.8, 6.3) m. CONCLUSION: Adjunct home-centered activity-based therapy was safe and feasible, but did not result in appreciable gains over 6 months.
Authors: Dan Tao; Yang Gao; Alistair Cole; Julien S Baker; Yaodong Gu; Rashmi Supriya; Tomas K Tong; Qiuli Hu; Roger Awan-Scully Journal: Front Physiol Date: 2022-06-13 Impact factor: 4.755