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

Primary Purpose

Cerebral Palsy, Prosthesis User

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Occupational Therapy Treatment
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prosthesis

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score
The Assisting Hand Assessment (AHA) is a test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance. An assessment is performed by observing the child's spontaneous handling of toys in a relaxed and playful session. Scores based on 22-items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective). The range of sum scores is 22-88 points. A clinical significant increase in score indicates an increase in quality of performance.
Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment
The PMAL is a structured interview in which the caregiver reports "How Often" (amount) and "How Well" (quality of movement) the child uses their involved upper limb when completing 22 activities of daily living. Scores range from 0-10; the higher the score, the better the quality of movement. An increase in PMAL score indicates a higher amount of upper extremity use and better quality of movement.
Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores
The Melbourne Assessment 2 (MA2) is a valid and reliable criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years: (i) Range of motion, (ii) Accuracy of reach and placement, (iii) Dexterity of grasp, release and manipulation and (iv) Fluency of movement. An increase in score indicates an increase in upper limb movement quality.

Secondary Outcome Measures

Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment
The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. 7 sub-tests will be reported on. Higher scores indicate better HRQOL (Health-Related Quality of Life), an increase in score indicates an increase in HRQOL.

Full Information

First Posted
April 17, 2017
Last Updated
October 29, 2020
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03122171
Brief Title
Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy
Official Title
Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
January 13, 2020 (Actual)
Study Completion Date
January 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Prosthesis User

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prosthesis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Occupational Therapy Treatment
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score
Description
The Assisting Hand Assessment (AHA) is a test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance. An assessment is performed by observing the child's spontaneous handling of toys in a relaxed and playful session. Scores based on 22-items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective). The range of sum scores is 22-88 points. A clinical significant increase in score indicates an increase in quality of performance.
Time Frame
Week 8
Title
Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment
Description
The PMAL is a structured interview in which the caregiver reports "How Often" (amount) and "How Well" (quality of movement) the child uses their involved upper limb when completing 22 activities of daily living. Scores range from 0-10; the higher the score, the better the quality of movement. An increase in PMAL score indicates a higher amount of upper extremity use and better quality of movement.
Time Frame
8 weeks
Title
Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores
Description
The Melbourne Assessment 2 (MA2) is a valid and reliable criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years: (i) Range of motion, (ii) Accuracy of reach and placement, (iii) Dexterity of grasp, release and manipulation and (iv) Fluency of movement. An increase in score indicates an increase in upper limb movement quality.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment
Description
The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. 7 sub-tests will be reported on. Higher scores indicate better HRQOL (Health-Related Quality of Life), an increase in score indicates an increase in HRQOL.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Chu, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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

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