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

NCT07253857 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Cerebral Palsy, Spastic

Interventions

OTHER

GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity

Hand Arm Bimanual Intensive Therapy Including Lower Extremity being a task based intensive therapy activities will be structured according to the participants ability to preform it. The intervention incorporates structured bimanual activities that progressively increase in motor complexity, along with functional tasks that necessitate coordinated use of both hands, systematically integrating postural and lower-extremity demands. Before therapy begins, each child will participate in a baseline assessment, skilled, repetitive UE movements will be encouraged through both whole task practices where child performs the entire movement without breaking it into smaller component (15-30 min) and part task practice (for 30 sec) .The tasks will be modified to include challenges related to lower extremity and bimanual coordination in upper limb.

OTHER

GROUP-B , Conventional Physical Therapy

Conventional therapy will include stretches of lower extremity following bobath approach and cognitive exercises.

Sponsors & Collaborators

  • Lahore University of Biological and Applied Sciences

    lead OTHER

Principal Investigators

  • Aruba Saeed · Lahore University of Biological and Applied Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-20
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07253857 on ClinicalTrials.gov