NCT02218593

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

February 1, 2024

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

August 13, 2014

Results QC Date

April 20, 2023

Last Update Submit

January 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

WREX orthosis

When the subject used the WREX Orthosis

Device: WREX orthosis

Interventions

Upper extremity exoskleton used to assist movement

WREX orthosis

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

People with Neuromuscular disease who use the Wilmington Robotic Exoskleton

You may qualify if:

  • Neuromuscular disease
  • Use the Wilmington Robotic Exoskeleton

You may not qualify if:

  • people who do not use the Wilmington Robotic Exoskeleton

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscular DystrophiesArthrogryposisMuscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesJoint DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesSpinal Cord DiseasesCentral Nervous System DiseasesMotor Neuron DiseaseNeurodegenerative Diseases

Results Point of Contact

Title
Director of Clinical Trials
Organization
Nemours Children's Health

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Research Engineer

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 18, 2014

Study Start

July 1, 2014

Primary Completion

October 1, 2014

Study Completion

July 1, 2015

Last Updated

February 2, 2024

Results First Posted

February 1, 2024

Record last verified: 2024-01