WREX Outcome Study

Spinal Muscular Atrophy Clinical Trial

Official title:

WREX Outcome Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218593
• Other study ID #: 579772-2
• Status: Completed
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2024
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

Inclusion Criteria:

• Neuromuscular disease

• Use the Wilmington Robotic Exoskeleton

Exclusion Criteria:

• people who do not use the Wilmington Robotic Exoskeleton

Related Conditions & MeSH terms

• Arthrogryposis
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Muscular Dystrophies
• Muscular Dystrophy
• Spinal Muscular Atrophy

Intervention

Device:
• WREX orthosis
Upper extremity exoskleton used to assist movement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Canadian Occupational Performance Measure (COPM)	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.	Surveys were conducted at a single timepoint for each subject. The surveys were administered over a 4-month period for all the subjects.