Neuromuscular electrical stimulation combined with Leap Motion hand exercises for children with cerebral palsy
The Effects of Neuromuscular Electrical Stimulation and Leap Motion-Based Exercises on Hand Function Parameters in Cerebral Palsy
This study will test whether adding neuromuscular electrical stimulation and Leap Motion-based hand exercises to conventional therapy improves hand function in children aged 6–15 with spastic cerebral palsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Sponsor | Medipol University Academic / other |
| Locations | 1 site (Istanbul, Beykoz) |
| Trial ID | NCT07311018 on ClinicalTrials.gov |
What this trial studies
Children with spastic unilateral or bilateral cerebral palsy and distal upper-extremity involvement (ages 6–15) will receive a program that includes Leap Motion-based interactive exercises, neuromuscular electrical stimulation (NMES), and conventional exercises. Eligibility requires GMFCS and MACS levels I–III, limited spasticity (MAS 0–1+), no botulinum toxin or surgery in the prior 6 months, and the ability to follow verbal instructions. Outcomes focus on upper extremity function, hand use in daily activities, and tolerance of the combined technology-based and conventional interventions. The intervention is delivered at the Physiotherapy and Rehabilitation Department of Istanbul Medipol University.
Who should consider this trial
Good fit: Ideal candidates are children aged 6–15 with spastic unilateral or bilateral cerebral palsy involving the wrist/fingers, GMFCS and MACS I–III, MAS 0–1+, no recent upper-extremity botulinum toxin or surgery, and the ability to follow verbal instructions.
Not a fit: Children with severe spasticity, significant cognitive impairment or sensory deficits, epilepsy, visual or hearing impairments, ongoing specific hand rehabilitation, or recent upper-extremity surgery/botulinum toxin are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, the approach could improve hand strength, coordination, and everyday hand use, helping children perform daily activities more independently.
How similar studies have performed: Earlier small studies and pilot trials of NMES and virtual-reality or motion-capture exercises (including Leap Motion) have reported modest improvements in hand function, but overall evidence is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of spastic unilateral or bilateral cerebral palsy based on clinical and MRI findings. * Involvement of the distal upper extremity (wrist and/or fingers). * Aged between 6 and 15 years. * No history of botulinum toxin injection or surgical intervention to the upper extremity within the past 6 months. * Gross Motor Function Classification System (GMFCS) levels I-III. * Manual Ability Classification System (MACS) levels I-III. * Upper extremity spasticity corresponding to 0, 1, or 1+ on the Modified Ashworth Scale (MAS). * Passive wrist extension limitation not exceeding 10 degrees. * Ability to follow verbal instructions (mental level reported as "normal" or "mild mental retardation" in the medical record). Exclusion Criteria: * Currently participating in a specific hand rehabilitation program. * Presence of visual or hearing impairment. * History of epilepsy. * Presence of chronic, orthopedic, or systemic conditions that may interfere with participation. * GMFCS levels IV or V. * MACS levels IV or V.
Where this trial is running
Istanbul, Beykoz
- Istanbul Medipol University, Physiotherapy and Rehabilitation Department — Istanbul, Beykoz, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Hande Özlü Erdoğan, MSc, PhD Candidate, PT
- Email: handeeozlu@gmail.com
- Phone: +905367075474
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.