Skip to main content
Clinical Trials/NCT03153254
NCT03153254
Unknown
Not Applicable

Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients

Thomas More Kempen4 sites in 1 country20 target enrollmentSeptember 15, 2017
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Thomas More Kempen
Enrollment
20
Locations
4
Primary Endpoint
Investigate user experience by a self-composed questionnaire.
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to investigate the usability of a new upper limb robot assisted therapy device in stroke patients.

Detailed Description

The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT. In this pilot study, the usability of a new upper arm RAT device for upper arm rehabilitation in stroke patients is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow, which is combined with a stabilizing shoulder brace and a bionic glove.

Registry
clinicaltrials.gov
Start Date
September 15, 2017
End Date
September 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lieven De Maesschalck

Innovation Manager

Thomas More Kempen

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Investigate user experience by a self-composed questionnaire.

Time Frame: Up to 30 minutes at the last session

Investigate user experience by a self-composed questionnaire with theorems where upon users have to score. Possible scores range from 1 (totally disagree) to 4 (totally agree).

Secondary Outcomes

  • Measure the rate of perceived exertion by the Borg scale.(Up to 5 minutes at the last session)
  • Investigate whether wearing the device improves functionality by the Action Research Arm Test (ARAT).(Up to 5 weeks (at week 1, week 2 and week 5))

Study Sites (4)

Loading locations...

Similar Trials