Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
NCT07253857

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

Led by Lahore University of Biological and Applied Sciences · Updated on 2026-01-13

42

Participants Needed

1

Research Sites

18 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 6Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with diplegic cerebral palsy
  • Manual ability level between 1 and 3 on the manual ability classification system
  • Gross motor function classification system level between 1 and 3
  • Ability to grasp light objects and lift the more affected arm at least 15 cm above a table
  • Baseline cognition score of 20 or higher on the mini mental state exam for children (MMC)
Not Eligible

You will not qualify if you...

  • Uncontrolled seizures
  • Botulinum toxin injections within the last 6 months or planned within this period
  • Recent orthopedic interventions that may affect motor function
  • Visual impairments that interfere with the treatment protocol

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pakistan Society for Rehabilitation of Differently Abled (PSRD)

Lahore, Punjab Province, Pakistan, 54660

Actively Recruiting

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Research Team

A

Aleena Ishfaq, DPT

CONTACT

A

Aruba Saeed, NMPT, PhD*

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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