Status:
RECRUITING
Unsupervised Therapy After Stroke in the Home Setting with a Hand Rehabilitation Device (ReHandyBot)
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
Clinica Hildebrand Brissago
Conditions:
Stroke
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The ReHandyBot is a robot for hand rehabilitation after stroke. The aims of this study are (1) to investigate the feasibility of unsupervised therapy with the ReHandyBot with stroke inpatients, first ...
Eligibility Criteria
Inclusion
- Informed Consent signed by the subject;
- female and male patients between 18 and 90 years old;
- acute/subacute stroke (recruitment within 12 weeks from stroke onset);
- pre-stroke modified Rankin score ≤ 1;
- National Institutes of Health Stroke Scale (NIHSS) ≥ 1 in at least one of the items regarding motor functions, sensory functions and ataxia;
- possibility (e.g., enough space) to set up the ReHandyBot at home.
Exclusion
- modified Ashworth Scale \> 2 for one or more of the following muscles: shoulder adductors, forearm pronator and supinator, flexors and extensors of elbow, wrist and fingers;
- moderate to severe aphasia: Goodglass-Kaplan's scale \< 3;
- moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) \< 9;
- functional impairment of the upper limb due to other pathologies;
- severe pain in the affected arm: visual analogue scale for pain (VASp) ≥ 5;
- other pathologies which may interfere with the study;
- pacemakers and other active implants;
- after discharge the patient will go to an assisted living facility (e.g., care home).
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06057129
Start Date
November 13 2023
End Date
April 1 2026
Last Update
November 1 2024
Active Locations (1)
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1
Clinica Hildebrand Centro di riabiliazione Brissago
Brissago, Canton Ticino, Switzerland, 6614