WREX Outcome Study

• Sponsor: Nemours Children's Clinic (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02218593
• Collaborator: (none)
• Enrollment: 42
• Arm: 1
• Duration (Months): 12

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Muscular Dystrophy; Arthrogryposis; Spinal Muscular Atrophy	Device: WREX orthosis	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Official Title: WREX Outcome Study
• Study Start Date: Jul 1, 2014
• Anticipated Primary Completion Date: Oct 1, 2014
• Anticipated Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: WREX orthosis WREX Orthosis	Device: WREX orthosis; Upper extremity exoskleton used to assist movement

Outcome Measures

Primary Outcome Measures

1. Activities of daily living [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Neuromuscular disease

• Use the Wilmington Robotic Exoskeleton

Exclusion Criteria:

• people who do not use the Wilmington Robotic Exoskeleton

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nemours Children's Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tariq Rahman, Prinicipal Research Engineer, Nemours Children's Clinic
• ClinicalTrials.gov Identifier: NCT02218593
• Other Study ID Numbers: 579772-2
• First Posted: Aug 18, 2014
• Last Update Posted: Aug 18, 2014
• Last Verified: Aug 1, 2014

• Additional relevant MeSH terms: Muscular Dystrophies; Arthrogryposis; Muscular Atrophy; Muscular Atrophy, Spinal

Study Results

No Results Posted as of Aug 18, 2014