Status:
COMPLETED
Error-enhancement for Arm Rehabilitation Post Stroke
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
KU Leuven
Bioxtreme Ltd.
Conditions:
Chronic Stroke
Eligibility:
All Genders
Up to 85 years
Phase:
EARLY_PHASE1
Brief Summary
Even in a chronic phase after stroke, most patients have difficulty moving the affected arm, resulting in limitations in simple tasks in daily living, most frequently limiting reaching task. In the ch...
Detailed Description
The overall aim of this study is to gain knowledge into the potential of error-enhancement robot training in patients with upper limb impairments in the chronic phase after stroke. Error-enhancement i...
Eligibility Criteria
Inclusion
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- First stroke, confirmed by neurologist based on clinical and/or imaging findings
- Ischemic/hemorrhagic stroke, at least more than six months ago
- Stroke affecting the dominant/non-dominant upper limb (unilateral weakness)
- Less than 85 years old
- Having a motor impairment yet no severe spasticity in the upper limb: be able to open and close the hand 5 times and be able to flex and extend the elbow 2 times but score less than 66 (maximum) on the Fugl-Meyer Assessment.
Exclusion
- Having sensory aphasia (evaluated by item 9 of the National Institutes of Health Stroke Scale)
- Having apraxia (evaluated by the apraxia screen of TULIA)
- Having neglect (evaluated by the Star Cancellation Test)
- Cognitive deficit with a score under 24 out of 30 on the Mini-mental State Examination
- Shoulder pain (yes/no)
- Providing no informed consent
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05229185
Start Date
January 25 2022
End Date
November 23 2022
Last Update
March 31 2023
Active Locations (1)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000