Clinical Trial

Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity in Spastic Cerebral Palsy

Study acronym: HABIT-ILE
Recruiting
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Summary
Cerebral palsy (CP), particularly the spastic diplegic subtype, is characterized by motor impairments such as spasticity and mobility limitations. In addition to motor dysfunction, children with CP often experience cognitive impairments affecting decision-making, problem-solving, working memory, selective attention, and inhibitory control. These non-motor challenges contribute to reduced social interaction and quality of life. Hand-Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) has demonstrated improvements in gross motor function among children with spastic CP. However, evidence regarding its impact on cognitive outcomes remains limited. This randomized controlled trial (RCT) aims to evaluate the effects of HABIT-ILE compared with conventional therapy on both motor and cognitive functions in children with spastic diplegic CP. By addressing both upper and lower limb the research seeks to provide a comprehensive therapeutic approach that may yield more significant developmental benefits. Ultimately, the findings could inform the interventions for improving outcomes in pediatric populations affected by diplegic cerebral palsy. Participants will receive 90 hours of intervention, with assessments conducted at baseline, mid-intervention, and post-intervention. The study will investigate outcomes across motor domains and cognitive functions such as inhibitory control and working memory. Findings are expected to inform comprehensive therapeutic approaches to improve developmental outcomes and quality of life in pediatric populations affected by spastic diplegic CP.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-05 -> 2026-06 2026-06-19
minor Completion pushed: 2026-05 -> 2026-06 2026-06-19
Trial Details
NCT Number NCT07253857
Lead Sponsor Lahore University of Biological and Applied Sciences
Conditions Cerebral Palsy, Cerebral Palsy, Spastic
Enrollment 42 participants
Start Date 2025-12-20
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-18