Clinical Feasibility of Minimally Supervised Therapy After Stroke With a Hand Rehabilitation Robot

Federal Institute of Technology (ETH) Zurich

Status

Completed

Conditions

Stroke

Treatments

Device: Minimally supervised therapy with the ReHapticKnob

Study type

Interventional

Funder types

Other

Identifiers

NCT04388891

ReHapticKnob 2020

Details and patient eligibility

About

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 clinic, evaluate the usability of the ReHapticKnob (user interface and implemented exercises which were adapted for independent usage), and quantify the dose of additional robotic therapy that patients perform in a minimally supervised setting.

Minimally supervised therapy means that after a training phase, where the therapists teach to the patients how to perform the exercises with the robot, the patients can autonomously train with the robot during free time without being directly supervised. Our hypothesis is that minimally supervised therapy might be a possible way to increase therapy dose for stroke patients, with the potential to further improve recovery of hand function with minimal additional burden for therapists and for the healthcare system.

Enrollment

23 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.