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

Recruiting now · Not applicable

Conditions studied: Cerebral Palsy, Cerebral Palsy, Spastic

In brief

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.

Key facts

Study ID: NCT07253857
Run by: Lahore University of Biological and Applied Sciences
People needed: 42
Starts: 2025-12-20
Expected to finish: 2026-06-01
Last updated by the study team: 2026-06-18

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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

Where it is running

Pakistan Society for Rehabilitation of Differently Abled (PSRD) — Lahore, Punjab Province, Pakistan (enrolling)

Full record on ClinicalTrials.gov

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