CompletedNot Applicable

Intensive Bimanual Therapy Versus Conventional Physical Therapy in Quadriplegic Cerebral Palsy

Pakistan30 participantsStarted 2025-04-15

Plain-language summary

Quadriplegic cerebral palsy (CP) is a severe neurological condition affecting motor control in all four limbs, often resulting in profound functional limitations in daily activities. Impaired upper limb function restricts children's ability to perform essential self-care, educational, and play tasks. Intensive Bimanual Therapy (IBT) is a rehabilitation approach that engages both hands in coordinated, repetitive, and task-specific activities to promote motor learning and functional independence. Conventional Physical Therapy (CPT), while widely used, primarily targets gross motor skills and may not fully address complex bilateral coordination needs. This randomized controlled trial is designed to compare the effects of IBT and CPT on upper limb function in children with quadriplegic CP. Thirty children aged 2-6 years, classified at Gross Motor Function Classification System (GMFCS) levels III-IV, will be randomly assigned to either CPT alone or a combination of CPT and IBT. The Able Hand Questionnaire (ABL) will be used to measure functional bimanual use before and after an 8-week intervention period. The study aims to determine whether IBT offers additional benefits over standard therapy in enhancing bimanual coordination and functional independence in this population.

Who can participate

Age range

2 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children with quadriplegic cerebral palsy.(Te Velde et al., 2021) * The target population consisted of children aged 2-6 years (Horwood et al., 2019) * Classified as level 3 and 4 in the GMFCS (Sogbossi et al., 2021) * Muscle tone grade 2 at modified Ashwarth scale.(Sogbossi et al., 2021) * Sufficient cognitive function to follow simple instructions and physically able to engage in sitting and standing exercises. (Chaovalit et al., 2021) Exclusion Criteria: * Joint contractures that interfere with bimanual tasks. * History of upper limb orthopedic surgery * Within the last half a year or botulinum toxin injections. * Poor compliance with therapy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in functional bimanual hand use as measured by the Able Hand Questionnaire (ABL)

Timeframe: Baseline and 8 weeks post-intervention

Trial details

NCT IDNCT07134894

SponsorUniversity of Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-04

View on ClinicalTrials.gov More Quadriplegic Cerebral Palsy trials