Wearable technology to improve upper limb function in children with unilateral cerebral palsy
Innovative Use of Wereable Technology for Improving Functionality in Children with Unilateral Cerebral Palsy
PHASE2; PHASE3 · Universidade da Coruña · NCT06872736
This study is testing a wearable device to see if it can help young children with unilateral cerebral palsy use their affected arm better in daily activities.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Universidade da Coruña (other) |
| Locations | 1 site (A Coruña, A Coruña) |
| Trial ID | NCT06872736 on ClinicalTrials.gov |
What this trial studies
This national interventional study aims to evaluate the effectiveness of a wearable device, WeFun, designed to enhance the functionality of the affected upper limb in children with unilateral cerebral palsy (UCP). The study focuses on children aged 3 to 8 years who are classified as levels I to III on the Manual Ability Classification System. Participants will engage in home-based training that incorporates the wearable technology to assess and improve their upper limb movement and daily living activities. The goal is to increase the spontaneous use of the affected limb, thereby enhancing overall participation and quality of life.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 8 years with a confirmed diagnosis of unilateral cerebral palsy and classified as levels I to III on the Manual Ability Classification System.
Not a fit: Patients who have had recent botulinum toxin injections or surgical interventions in the upper limb, or those with uncontrolled medical complications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the independence and quality of life for children with unilateral cerebral palsy.
How similar studies have performed: Other studies utilizing wearable technology for rehabilitation in similar populations have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of UCP. * Children aged between 3 and 8 years old. * Children rated on levels I to III on the Manual Ability Classification System (MACS). Exclusion Criteria: * Botulinum toxin injection or surgical interventions in the upper limb within 6 months prior to study entry. * Medical complications non-controlled that would interfere with study participation (e.g., not controlled epilepsy). * Predominantly athetoid or dystonia movement patterns. * Insufficient cognitive level to follow instructions, * Non-corrected marked visual impairments. Families can be retired from the study after starting if: * Families don't assist or don't collaborate in the weekly sessions with the reference person. * Wearable activity if presumably lower than expected (few recordings of activity, \<20%). * Families don't provide feedback about daily sessions through the satisfaction system in the app/registration sheet.
Where this trial is running
A Coruña, A Coruña
- Universidade da Coruña — A Coruña, A Coruña, Spain (RECRUITING)
Study contacts
- Study coordinator: Verónica Robles García, PhD
- Email: veronica.robles@udc.es
- Phone: +34 981167000
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.
Conditions: Unilateral Cerebral Palsy, children, unilateral cerebral palsy, function, mobility, upper limb, weareable, technology