Hand-and-arm intensive therapy with lower-limb training for children with spastic diplegic cerebral palsy
Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity on Motor Function and Cognition in Children With Spastic Cerebral Palsy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Lahore University of Biological and Applied Sciences Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07253857 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous HABIT-ILE studies have shown improvements in gross motor function, but evidence for cognitive benefits remains limited.
Eligibility criteria
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 this trial is running
Lahore, Punjab Province
- 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
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.