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Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy

NCT03122171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-11-20

Study results available
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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.

Conditions

  • Cerebral Palsy
  • Prosthesis User

Interventions

OTHER

Occupational Therapy Treatment

Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).

Sponsors & Collaborators

Principal Investigators

  • Alice Chu, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2020-01-13
Completion
2020-01-13

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03122171 on ClinicalTrials.gov