Bimanual versus unilateral arm training for children with spastic hemiplegic cerebral palsy
Bimanual Training Versus Unilateral Task Specific Training in Children With Spastic Hemiplegic Cerebral Palsy
This project will test whether using both hands together (bimanual training) or focused practice of the affected hand (unilateral task-specific training) helps children aged 5–12 with spastic hemiplegic cerebral palsy improve arm function and reduce spasticity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 5 Years to 15 Years |
| Sex | All |
| Sponsor | University of Lahore Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07437274 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will assign children with spastic hemiplegic cerebral palsy to receive either bimanual training or unilateral task-specific training and compare changes in spasticity and functional independence. The planned sample includes about 46 participants to allow for dropout, with intervention delivered over the study period and outcomes measured with tools such as the Modified Ashworth Scale and functional independence measures. Participants are recruited from clinical sites and randomized using sealed envelopes to maintain allocation concealment. The trial focuses on goal-directed, repetitive upper-limb activities tailored to each child’s abilities.
Who should consider this trial
Good fit: Ideal candidates are children aged 5–12 with confirmed spastic hemiplegic cerebral palsy, GMFCS levels I–III, Modified Ashworth Scale scores of 1–3 in the affected upper limb, who can follow simple instructions and sit unsupported.
Not a fit: Children with mixed or non-spastic types of cerebral palsy, very severe spasticity, recent upper-limb surgery or botulinum toxin within six months, or major sensory/cognitive impairments are unlikely to benefit from this specific comparison.
Why it matters
Potential benefit: If successful, the results could help identify which training method better improves affected arm function and daily independence for these children.
How similar studies have performed: Both bimanual training and unilateral task-specific approaches have shown benefit in prior pediatric neurorehabilitation studies, but direct head-to-head comparisons in spastic hemiplegic CP remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lahore, Punjab Province
- University of Lahore Teaching Hospital, Lahore — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Muhammad Hasnain Soomro, MSPTN — The University of Lahore, Lahore
- Study coordinator: Muhammad Hasnain Soomro, MSPTN
- Email: drhasnainsoomro@gmail.com
- Phone: 03158463003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.