WREX Outcome Study

Completed

• Conditions: Arthrogryposis; Spinal Muscular Atrophy; Muscular Dystrophy
• Interventions: Device: WREX orthosis

• Registration Number: NCT02218593
• Lead Sponsor: Nemours Children's Clinic

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-18
• Primary Completion: 2014-10
• Study Completion: 2015-07
• Results First Submitted: 2023-04-20
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-31
• Results First Posted: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Neuromuscular disease
• Use the Wilmington Robotic Exoskeleton

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Exclusion Criteria

• people who do not use the Wilmington Robotic Exoskeleton

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WREX orthosis	WREX orthosis	When the subject used the WREX Orthosis

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM)	Surveys were conducted at a single timepoint for each subject. The surveys were administered over a 4-month period for all the subjects.	Performance score on The Canadian Occupational Performance Measure (COPM). The total score range is 1-10. A score of 1 indicates indicates poor performance and low satisfaction and 10 indicates good performance and high satisfaction. The numbers indicate scores on a scale.