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Recruiting NCT07253857

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

Trial Parameters

Condition Cerebral Palsy
Sponsor Lahore University of Biological and Applied Sciences
Study Type INTERVENTIONAL
Phase N/A
Enrollment 42
Sex ALL
Min Age 6 Years
Max Age 12 Years
Start Date 2025-12-20
Completion 2026-05
Interventions
GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower ExtremityGROUP-B , Conventional Physical Therapy

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Diagnosed with diplegic cerebral palsy * CP children with manual ability level 1-3 on manual ability classification system * Participants with gross motor function classification system level ranging from 1-3 will be included in the study. * With an ability to grasp light objects and lift the more affected arm 15 cm above a table surface. * Base line cognition level should be 20 or above assessed through mini mental state exam for children (MMC). Exclusion Criteria: * Uncontrolled seizures * Recent or planned botulinum toxin injections within 6 months * Any recent orthopedic interventions that may affect motor function * Visual impairments impeding with treatment protocol

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