Trials / Unknown
UnknownNCT05024409
Cerebral Palsy Upper Extremity Orthotic Device
Use of Low Cost Orthotic Device to Improve Upper Extremity Function in Children With Cerebral Palsy
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Rutgers, The State University of New Jersey · Academic / Other
- Sex
- All
- Age
- 4 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
Upper extremity therapies for children with cerebral palsy (CP) have been validated for improving function in higher functioning patients. Those who function at the lowest end of the scale, on the Manual Ability Classification System scale (MACS) III-V, comprise 34-54% of the population, but as yet have no evidence-based interventions specific to their needs. Lower functioning children often retain some voluntary control of the elbow in spite of limited finger motion. A dynamic splint, or exoskeleton, could utilize the tenodesis effect from elbow motion to drive finger release while retaining flexor tone for grasp, potentially creating a portable, home-based therapeutic tool. The purpose of this study is to assess the effectiveness of an upper extremity orthotic device in improving the upper extremity function of children with cerebral palsy who have limited use of their hands.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Upper Extremity Orthotic | 3D printed orthotic which uses elbow motion to facilitate finger extension |
| OTHER | Occupational Therapy | 6 weekly sessions of occupational therapy, without use of an assistive orthotic device |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2025-09-01
- Completion
- 2025-12-01
- First posted
- 2021-08-27
- Last updated
- 2023-12-26
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05024409. Inclusion in this directory is not an endorsement.