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WREX Outcome Study

Primary Purpose

Muscular Dystrophy, Arthrogryposis, Spinal Muscular Atrophy

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

WREX orthosis

About this trial

This is an interventional treatment trial for Muscular Dystrophy

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Neuromuscular disease
Use the Wilmington Robotic Exoskeleton

Exclusion Criteria:

people who do not use the Wilmington Robotic Exoskeleton

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WREX orthosis

Arm Description

WREX Orthosis

Outcomes

Primary Outcome Measures

Activities of daily living

Secondary Outcome Measures

Full Information

NCT ID

NCT02218593

First Posted

August 13, 2014

Last Updated

March 16, 2023

Sponsor

Nemours Children's Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02218593

Brief Title

WREX Outcome Study

Official Title

WREX Outcome Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nemours Children's Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is to evaluate how the Wilmington Robotic Exoskeleton (WREX) is working for children who are using the WREX, or have used it in the past. The survey consists of a set of questions a) performed online and b) performed over the phone.

Detailed Description

The WREX (Wilmington Robotic EXoskeleton) is being used by many children with neuromuscular conditions such as arthrogryposis and muscular dystrophy. Nemours/A.I. duPont Hospital for Children alone has provided a WREX for about 80 children in the last 3 years. This is being done through the orthopedic and muscle clinics in the hospital. We would like to perform a retrospective study to see how well the children are doing with the WREX. We propose getting this feedback through a survey administered to families using the WREX. The survey will be performed in two parts. 1) A phone survey will use the Canadian Occupational Performance Measure (COPM). 2) an online survey with additional questions. The parents are asked to submit answers on behalf of the children if they are unable to.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscular Dystrophy, Arthrogryposis, Spinal Muscular Atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WREX orthosis

Arm Type

Experimental

Arm Description

WREX Orthosis

Intervention Type

Device

Intervention Name(s)

WREX orthosis

Intervention Description

Upper extremity exoskleton used to assist movement

Primary Outcome Measure Information:

Title

Activities of daily living

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Neuromuscular disease Use the Wilmington Robotic Exoskeleton Exclusion Criteria: people who do not use the Wilmington Robotic Exoskeleton

12. IPD Sharing Statement

Learn more about this trial

WREX Outcome Study

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