Bimanual Training Versus Unilateral Task Specific Training in Children With Spastic Hemiplegic Cerebral Palsy (BUST-CP)

March 5, 2026 updated by: Montiha Azeem

Cerebral palsy is one of the most common childhood neurological disorders and often results in weakness, poor coordination, and stiffness (spasticity) in one side of the body in children with spastic hemiplegic cerebral palsy. These difficulties can significantly affect a child's ability to perform daily activities such as dressing, eating, playing, and school-related tasks.

Upper limb rehabilitation plays a crucial role in improving independence and quality of life in these children. Two commonly used rehabilitation approaches are bimanual training, which focuses on using both hands together during functional tasks, and unilateral task-specific training, which focuses intensively on improving the affected hand through repetitive, goal-directed activities.

Although both approaches are widely practiced in pediatric neurorehabilitation, there is limited direct comparison of their effectiveness in reducing spasticity and improving functional independence among children with spastic hemiplegic cerebral palsy, particularly in the local population of Pakistan.

This randomized controlled trial aims to compare the effectiveness of bimanual training versus unilateral task-specific training in children aged 5-12 years diagnosed with spastic hemiplegic cerebral palsy. A total of 46 participants will be randomly assigned to one of two intervention groups. Both groups will receive therapy three times per week for eight weeks.

Spasticity will be measured using the Modified Ashworth Scale (MAS), and functional independence will be assessed using the Pediatric Evaluation of Disability Inventory (PEDI). Assessments will be conducted before and after the intervention period.

The results of this study may help clinicians, caregivers, and rehabilitation centers determine which therapy approach is more effective in improving upper limb function and independence in children with spastic hemiplegic cerebral palsy. Participation in this study is voluntary, and children may withdraw at any time without affecting their standard care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Design

This study is a randomized controlled trial (RCT) designed to compare the effectiveness of bimanual training and unilateral task-specific training on spasticity and functional independence in children with spastic hemiplegic cerebral palsy.

Study Setting and Duration

Data will be collected from Sukkur Institute of Nursing and Allied Health Sciences, Blood Bank Hospital Sukkur, and Hidayat Physiotherapy and Rehabilitation Center. The study duration will be nine months following approval of the synopsis.

Sample Size

The calculated sample size is 46 participants, including a 20% anticipated dropout rate. The sample size was determined using the formula for comparing two means with a 95% confidence interval and 80% power. The final estimated sample includes 19 participants per group (38 total), adjusted to 46 to accommodate potential attrition.

Sampling Technique and Randomization

Participants will be recruited using a non-probability convenient sampling technique. After enrollment, children will be randomly assigned into two groups (Group A and Group B) using the sealed envelope method to ensure allocation concealment.

Selection Criteria Inclusion Criteria

Children aged 5-12 years diagnosed with spastic hemiplegic cerebral palsy.

GMFCS levels I-III.

Modified Ashworth Scale score between 1 and 3 in upper limb muscles.

Ability to follow simple instructions.

Ability to sit unsupported for at least 30 seconds.

Exclusion Criteria

Mixed types of cerebral palsy.

Recent orthopedic surgery or botulinum toxin injection within 6 months.

Severe sensory deficits.

Uncontrolled epilepsy.

Fixed contractures in the upper limb.

Severe behavioral or psychological disorders affecting participation.

Operational Definitions Spasticity

Spasticity is defined as a velocity-dependent increase in muscle tone resulting from hyperexcitability of the stretch reflex. It will be measured using the Modified Ashworth Scale (MAS), graded from 0 to 4, with higher scores indicating greater spasticity.

Functional Independence

Functional independence is defined as the child's ability to perform age-appropriate daily activities without physical assistance. It will be measured using the Pediatric Evaluation of Disability Inventory (PEDI), covering self-care, mobility, and social function domains.

Interventions Group A - Bimanual Training

Participants will receive structured bimanual training focused on improving coordinated use of both hands during functional tasks. Therapy will be delivered 3 sessions per week for 8 weeks, each session lasting 60 minutes. Activities will include buttoning, folding clothes, opening containers, block building, and bilateral play tasks. Sessions will be divided into three 20-minute blocks with 5-minute rest intervals.

Group B - Unilateral Task-Specific Training

Participants will receive unilateral task-specific training targeting the affected upper limb. Therapy will be delivered 3 sessions per week for 8 weeks, each session lasting 60 minutes. Activities will include grasp-and-release, reaching, stacking, drawing, card flipping, and object manipulation. The unaffected hand may be mildly restrained when necessary to encourage use of the affected limb.

Baseline Treatment

Both groups will receive standardized baseline physiotherapy education, including passive range-of-motion exercises, stretching, spasticity management techniques, and postural guidance. A home exercise booklet will be provided to caregivers.

Data Collection Procedure

Baseline assessments will be conducted before intervention. Post-intervention assessments will be performed after 8 weeks by blinded assessors to ensure objectivity. Data will be recorded on structured forms and securely stored for analysis.

Ethical Considerations

The study will be conducted according to the Declaration of Helsinki and institutional ethical guidelines. Written informed consent will be obtained from parents or guardians. Participation will be voluntary, and confidentiality will be strictly maintained. Participants may withdraw at any time without affecting their standard care.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Recruiting
        • University of Lahore Teaching Hospital, Lahore
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muhammad Hasnain Soomro, MSPTN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Both male and female Children diagnosed with spastic hemiplegic cerebral palsy (confirmed by a pediatric neurologist or rehabilitation specialist).

Age range: 5 to 12 years (suitable for both bimanual and unilateral task-specific training).

Gross Motor Function Classification System (GMFCS) levels I to III (ambulatory with or without limitations).

Modified Ashworth Scale score between 1 and 3 in the upper limb muscles (indicating mild to moderate spasticity).

Minimum cognitive ability to follow simple instructions, verified using screening tools (e.g., MMSE adapted for children).

Ability to sit unsupported for at least 30 seconds (to ensure safe participation in therapy).

Exclusion Criteria:

Children with mixed types of cerebral palsy (e.g., spastic quadriplegia, dyskinetic, or ataxic types).

Recent orthopedic surgery or botulinum toxin injections in the affected upper limb within the past 6 months.

Severe visual, auditory, or sensory deficits that could interfere with therapy participation or assessment accuracy.

Uncontrolled epilepsy or other neurological conditions that could compromise safety during therapy.

Fixed joint contractures or severe deformities in the upper limbs that limit passive range of motion Children with behavioral or psychological disorders (e.g., severe ADHD, autism spectrum disorder) that impair attention or participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A Bimanual Training Group
Participants in this group will receive structured bimanual training designed to improve coordination, reduce spasticity, and enhance functional use of both upper limbs. The intervention will be delivered three sessions per week for 8 weeks, with each session lasting 60 minutes. Activities will include repetitive, goal-directed bilateral tasks such as buttoning shirts, folding clothes, opening containers, building with blocks, and bimanual play activities. Each session will be divided into three 20-minute activity blocks with 5-minute rest intervals to prevent fatigue. All sessions will be supervised by a certified pediatric physiotherapist trained in neurorehabilitation. In addition, participants will receive standardized baseline physiotherapy education at the start of the study.
Behavioral: Bimanual Training

Bimanual training is a structured, task-oriented upper limb rehabilitation program designed to promote coordinated use of both hands during functional, goal-directed activities. The intervention emphasizes active involvement of the affected upper limb within bilateral tasks rather than isolating it. Therapy will be delivered three sessions per week for 8 weeks, with each session lasting 60 minutes.

Each session will consist of three 20-minute activity blocks with 5-minute rest intervals to reduce fatigue. Activities will include age-appropriate, real-life bilateral tasks such as buttoning shirts, folding clothes, opening containers, building with blocks, drawing with both hands, catching and throwing balls, and interactive bimanual play tasks. Task complexity will be progressively increased based on the child's tolerance and performance.

Unlike unilateral training, this approach focuses on improving interlimb coordination, motor planning, and functional integration of both upper limb
Active Comparator: group B Unilateral Task-Specific Training Group
Participants in this group will receive unilateral task-specific training focused on intensive use of the affected upper limb to promote neuroplasticity and functional recovery. The intervention will be delivered three sessions per week for 8 weeks, with each session lasting 60 minutes. Activities will include grasp-and-release exercises, reaching, stacking, drawing, flipping cards, and manipulation of objects using the affected hand. The unaffected hand may be mildly restrained when necessary to encourage active use of the affected limb without causing frustration. Sessions will be structured into three 20-minute blocks with 5-minute rest intervals. Standardized baseline physiotherapy education will also be provided at the beginning of the study.
Behavioral: Unilateral Task-Specific Training
Unilateral Task-Specific Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Upper Limb Spasticity Measured by Modified Ashworth Scale (MAS)
Time Frame: Baseline (Week 0) mid week(4), Post-intervention (Week 8)
Spasticity will be assessed using the Modified Ashworth Scale (MAS), a standardized clinical tool used to measure velocity-dependent resistance to passive muscle stretch. The MAS grades muscle tone on a scale from 0 to 4, with higher scores indicating greater spasticity. Upper limb muscle groups (including elbow flexors, wrist flexors, and finger flexors) will be evaluated by trained physiotherapists. The primary outcome will be the change in MAS score from baseline to post-intervention, comparing the effectiveness of bimanual training versus unilateral task-specific training in reducing spasticity.
Baseline (Week 0) mid week(4), Post-intervention (Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montiha Azeem

Investigators

  • Principal Investigator: Muhammad Hasnain Soomro, MSPTN, The University of Lahore, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 2, 2026

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOL/IREB/25/15/03/13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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