Hand-and-arm intensive therapy with lower-limb training for children with spastic diplegic cerebral palsy
Official title: Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity on Motor Function and Cognition in Children With Spastic Cerebral Palsy
Run by Lahore University of Biological and Applied Sciences · NCT07253857 · Data updated 2026-11-12
This trial tests whether an intensive bimanual hand-and-arm therapy that also includes lower-limb training (HABIT-ILE) helps children with spastic diplegic cerebral palsy improve motor and thinking skills.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 12 Years |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Lahore University of Biological and Applied Sciences Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Status | Recruiting |
| Started | December 20, 2025 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT07253857 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children with spastic diplegic cerebral palsy who have MACS and GMFCS levels 1–3, can grasp light objects and lift the more affected arm 15 cm, and score at least 20 on the MMC are the ideal candidates.
✕Probably not a fit
Children with uncontrolled seizures, recent or planned botulinum toxin within 6 months, recent orthopedic interventions affecting motor function, or visual impairments that prevent participation are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial compares HABIT-ILE, an intensive bimanual upper-limb program that also targets the lower extremities, with conventional physical therapy in children with spastic diplegic cerebral palsy. Eligible participants have MACS and GMFCS levels 1–3, can grasp light objects and lift the affected arm 15 cm, and have a baseline MMC score of 20 or higher. Outcomes include measures of gross motor function and cognitive/executive performance to determine whether adding lower-limb training produces broader functional gains. The intervention is delivered at a single site in Lahore and participants are randomized to receive either HABIT-ILE or usual therapy.
Why it matters
Potential benefit: If successful, HABIT-ILE could improve both motor abilities and executive cognitive skills, leading to greater independence and quality of life for children with spastic diplegic CP.
How similar studies have gone: Previous HABIT-ILE studies have shown improvements in gross motor function, but evidence for cognitive benefits remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Pakistan Society for Rehabilitation of Differently Abled (PSRD)
Lahore, Punjab Province, Pakistan Recruiting
Study contacts
- Principal investigator: Aruba Saeed — Lahore University of Biological and Applied Sciences
- Study coordinator: Aleena Ishfaq, DPT
- Email: draleenaishfaqpt@gmail.com
- Phone: +92 3324210141
Similar studies
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This study tests whether Sensory Integration Therapy helps improve gross motor function more than standard physical therapy in children aged 4–10 with mixed cerebral palsy.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.