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

NCT ID: NCT03122171

Last Updated: 2020-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2020-01-13

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy Prosthesis User

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Prosthesis

Group Type EXPERIMENTAL

Occupational Therapy Treatment

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alice Chu, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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16-02093

Identifier Type: -

Identifier Source: org_study_id