Status:
COMPLETED
Clinical Feasibility of Minimally Supervised Therapy After Stroke With a Hand Rehabilitation Robot
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
Clinica Hildebrand Brissago
Rehabilitation Engineering Laboratory, ETHZ
Conditions:
Stroke
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The ReHapticKnob is a robot for hand rehabilitation after stroke. We aim to investigate the feasibility of minimally supervised therapy with the ReHapticKnob with stroke patients in a rehabilitation c...
Eligibility Criteria
Inclusion
- Male and female stroke patients between 18 and 90 years old;
- pre-stroke Modified Rankin Score ≤ 1;
- acute/subacute stroke (within (≤) 6 weeks from onset);
- NIHSS ≥ 1 in at least one of the items regarding motor function, sensory functions and ataxia;
- the patient read, understood and signed the informed consent.
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 scale \< 3;
- moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) \< 8;
- 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.
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04388891
Start Date
August 11 2020
End Date
September 14 2023
Last Update
February 22 2024
Active Locations (1)
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1
Clinica Hildebrand Centro di riabiliazione Brissago
Brissago, Canton Ticino, Switzerland, 6614