Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy (ARTHE)
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|ClinicalTrials.gov Identifier: NCT03153254|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Test upper limb robot assisted therapy device Device: Training with new upper limb robot assisted therapy device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Phase 1: Healthy persons Phase 2: Stroke patients|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||September 30, 2018|
Experimental: Healthy persons
Test upper limb robot assisted therapy device. During 1 session of 1/2 hour.
Device: Test upper limb robot assisted therapy device
During 1 session of 1/2 hour.
Experimental: Stroke patients
Training with new upper limb robot assisted therapy device. During 2 to 5 sessions of 1/2 hour.
Device: Training with new upper limb robot assisted therapy device
During 2 to 5 sessions of 1/2 hour.
- 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).
- Measure the rate of perceived exertion by the Borg scale. [ Time Frame: Up to 5 minutes at the last session ]Measure the rate of perceived exertion by the Borg scale. The Borg scale is a way of measuring physical activity intensity level. Possible scores range from 0 (no fatigue at all) to 10 (worst imaginable fatigue).
- Investigate whether wearing the device improves functionality by the Action Research Arm Test (ARAT). [ Time Frame: Up to 5 weeks (at week 1, week 2 and week 5) ]The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153254
|Contact: Lieven De Maesschalck||014/56 23 10 ext email@example.com|
|Contact: Romy Sels||014/56 23 10 ext firstname.lastname@example.org|
|Edegem, Antwerp, Belgium, 2650|
|Contact: Christhophe Lafosse, Prof.|
|Thomas More - Mobilab||Completed|
|Geel, Antwerp, Belgium, 2440|
|REVAlution||Active, not recruiting|
|Herentals, Antwerp, Belgium, 2200|
|Revalidatie & MS Centrum||Recruiting|
|Overpelt, Antwerp, Belgium, 3900|
|Contact: Martine Verhoeven|
|Principal Investigator:||Lieven De Maesschalck||Thomas More Kempen|