RecruitingNot Applicable

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

Pakistan42 participantsStarted 2025-12-20

Plain-language summary

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.

Who can participate

Age range

6 Years – 12 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: * 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. * Base line cognition level should be 20 or above assessed through mini mental state exam for children (MMC). Exclusion Criteria: * 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

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.

1This trial combines hand, arm, and leg therapy together in an intensive way — can you help me understand whether this kind of combined approach makes sense for my child's specific level of spastic cerebral palsy, or whether focusing on one area first might be better?
2The trial is measuring things like how far my child can walk in 6 minutes and how well they can move blocks with their hands — given where my child is right now with their gross motor and hand skills, do you think these are realistic areas where we'd expect to see meaningful change?
3Since this study is listed as Phase NA, which often means it's testing a therapy approach rather than a drug, what do we actually know so far about the safety and any potential downsides of this kind of intensive bimanual therapy combined with lower extremity training for kids with spastic CP?
4The trial also measures executive function using a parent questionnaire called the BRIEF-2 — can you explain why they're tracking thinking and behavior skills alongside physical outcomes, and what that might mean for how my child would be evaluated throughout the study?
5Given that this trial is actively recruiting, are there other established therapy options my child could access right now that we should compare against before deciding whether joining a research study like this is the right path?

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

Gross Motor Function Measure 88 (GMFM-88)

Timeframe: 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

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

ABILOCO-KIDS-CP

ABILHAND-KIDS-CP

Box and Block Test (BBT)

Trial details

NCT IDNCT07253857

SponsorLahore University of Biological and Applied Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Aleena Ishfaq, DPT

+92 3324210141 draleenaishfaqpt@gmail.com

View on ClinicalTrials.gov More Cerebral Palsy trials