NCT07253857 Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity in Spastic Cerebral Palsy
| NCT ID | NCT07253857 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lahore University of Biological and Applied Sciences |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-12-20 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2025-12-20 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Aruba Saeed
PRINCIPAL INVESTIGATOR
Lahore University of Biological and Applied Sciences
Frequently Asked Questions
Who can join the NCT07253857 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07253857 currently recruiting?
Yes, NCT07253857 is actively recruiting participants. Contact the research team at draleenaishfaqpt@gmail.com for enrollment information.
Where is the NCT07253857 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT07253857 clinical trial?
NCT07253857 is sponsored by Lahore University of Biological and Applied Sciences. The principal investigator is Aruba Saeed at Lahore University of Biological and Applied Sciences. The trial plans to enroll 42 participants.
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