Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Thomas More Kempen
- Enrollment
- 20
- Locations
- 8
- Primary Endpoint
- Investigate user experience by a self-composed questionnaire.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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))
Investigators
Lieven De Maesschalck
Innovation Manager
Thomas More Kempen