Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy

Not Applicable

• Conditions: Stroke
• Interventions: Device: Training with new upper limb robot assisted therapy device; Device: Test upper limb robot assisted therapy device

• Registration Number: NCT03153254
• Lead Sponsor: Thomas More Kempen

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 Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Study Start: 2017-09-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Stroke patients	Training with new upper limb robot assisted therapy device	Training with new upper limb robot assisted therapy device. During 2 to 5 sessions of 1/2 hour.
Healthy persons	Test upper limb robot assisted therapy device	Test upper limb robot assisted therapy device. During 1 session of 1/2 hour.

Primary Outcome Measures

Name	Time	Method
Investigate user experience by a self-composed questionnaire.	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 Outcome Measures

Name	Time	Method
Measure the rate of perceived exertion by the Borg scale.	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).	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.

Trial Locations

Locations (4)

RevArthe; 🇧🇪 Edegem, Antwerp, Belgium

Revalidatie & MS Centrum; 🇧🇪 Overpelt, Antwerp, Belgium

REVAlution; 🇧🇪 Herentals, Antwerp, Belgium

Thomas More - Mobilab; 🇧🇪 Geel, Antwerp, Belgium