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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorLahore University of Biological and Applied Sciences

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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.

  • GROUP-B , Conventional Physical Therapy

    Other intervention

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

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: GROUP -A HABIT-ILE TherapyExperimental treatment 1 intervention
Group B: GROUP- B Conventional Physical TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Gross Motor Function Measure 88 (GMFM-88)

It is a standardized assessment tool designed to evaluate motor function in children with cerebral palsy (CP). It consists of 88 items that measure gross motor abilities across five domains: lying \& rolling, sitting, crawling \& kneeling, standing, and walking, running \& jumping. Each domain is scored on a 4-point ordinal scale where 0 indicates the child does not initiate the movement, 1 reflects initiation with less than 10% completion, 2 represents partial completion between 10% and less than 100%, and 3 denotes full completion of the movement as intended. Higher scores means that the child can move more independently while lower scores show difficulties in movement and point to areas where therapy is needed.

Time frame
Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9
2

Behavior Rating Inventory Of Executive Function-2 (BRIEF-2) Parent form

It assesses executive function in children, including those with cerebral palsy (CP), measuring impulse control, emotional regulation, and working memory

Time frame
Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9
3

ABILOCO-KIDS-CP

This assessment tool designed to evaluate locomotion ability in children with cerebral palsy

Time frame
Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9
4

ABILHAND-KIDS-CP

it is an assessment tool designed to evaluate manual ability in children with cerebral palsy. It focuses on bimanual activities, measuring the child's ability to perform daily tasks requiring upper limb coordination.

Time frame
Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.