N/A
N=6
Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy
Cerebral Palsy · Prosthesis User
Bottom Line
View on ClinicalTrials.gov: NCT03122171 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Occupational Therapy Treatment (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score |
4 | — |
| PRIMARY Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment |
4 | — |
| PRIMARY Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores |
4; 3; 3; 2 | — |
| SECONDARY Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment |
3; 3; 3; 2; 1; 1 | — |
Summary
The purpose of the study is to assess the effectiveness of an upper extremity prosthesis in improving the upper extremity function of children with cerebral palsy who have limited use of their hands. Twelve children, aged 4-17 years, who have cerebral palsy and limitations in their ability to use their hands, will be enrolled. All participants will be fitted with a 3D printed arm/hand prosthesis and receive 8 occupational therapy sessions. Each subject will be evaluated pre-treatment, post-occupational therapy sessions and at 6 months follow-up. The evaluation will include assessment of (1)passive and active arm/hand movement and (2)functional hand skills using several standardized tests. The results from the pre-treatment and the two post-treatment evaluations will be compared.
Eligibility Criteria
Inclusion Criteria
- Diagnosis: cerebral palsy
- 4-17 years old
- MACS levels III - V
- Active movement of wrist or elbow
Exclusion Criteria
- MACS levels I, II
- Botox or orthopedic surgery in past 6 months
- Severe contractures
- Lack of voluntary arm motion
Data sourced from ClinicalTrials.gov (NCT03122171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.