Trial Outcomes & Findings for WREX Outcome Study (NCT NCT02218593)

NCT ID: NCT02218593

Last Updated: 2024-02-02

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

Surveys were conducted at a single timepoint for each subject. The surveys were administered over a 4-month period for all the subjects.

Results posted on

2024-02-02

Participant Flow

Participant milestones

Participant milestones
Measure
WREX Orthosis
Children answering with WREX orthosis
Overall Study
STARTED
25
Overall Study
COMPLETED
25
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
WREX Orthosis
n=25 Participants
Children who have used a WREX Orthosis WREX orthosis: Upper extremity exoskeleton used to assist arm movement
Age, Continuous
8.72 years
STANDARD_DEVIATION 1.38 • n=25 Participants
Sex: Female, Male
Female
9 Participants
n=25 Participants
Sex: Female, Male
Male
16 Participants
n=25 Participants
Region of Enrollment
United States
25 Participants
n=25 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
WREX Orthosis
n=25 Participants
When the subject used the WREX Orthosis WREX orthosis: Upper extremity exoskleton used to assist movement
Canadian Occupational Performance Measure (COPM)
7.09 score on a scale
Standard Deviation 2.15

Adverse Events

WREX Orthosis

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials

Nemours Children's Health

Phone: 4076507652

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place