Clinical Feasibility of Minimally Supervised Therapy After Stroke With a Hand Rehabilitation Robot (ReHapticKnob): Pilot and Main Study

Swiss Federal Institute of Technology1 site in 1 country23 target enrollmentAugust 11, 2020

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Swiss Federal Institute of Technology
Enrollment: 23
Locations: 1
Primary Endpoint: Compliance as assessed by dose
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

August 11, 2020

End Date

September 14, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Swiss Federal Institute of Technology

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Compliance as assessed by dose

Time Frame: Compliance to minimally supervised therapy is calculated at the end of the fourth week of the study protocol.

Sum of the dose of robot-assisted therapy without direct supervision that the patient performs.

Secondary Outcomes

Change in the active Range of Motion (aROM) for forearm rotation as assessed by a custom robotic assessment(Baseline aROM is assessed at the beginning of the first week, final aROM is assessed at the end of the fourth week.)
Change in haptic perception as assessed by a custom robotic assessment measuring the minimum difference in stiffness that a patient can perceive(The baseline assessment is performed at the beginning of the first week, the final assessment is performed at the end of the fourth week.)
Usability as assessed by the System Usability Scale(Usability is measured again at the end of the fourth week.)
Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale(First to fourth week.)
Usability as assessed by the Post-Study System Usability Questionnaire(Usability is measured again at the end of the fourth week.)
Change in upper limb functions as assessed by the Motor Evaluation Scale for Upper Extremities in Stroke Patients (MESUPES)(Baseline functions are assessed at the beginning of the first week, final functions are assessed at the end of the fourth week.)
Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)(Baseline functions are assessed at the beginning of the first week, final functions are assessed at the end of the fourth week.)
Change in upper limb functions as assessed by the ABILHAND(Baseline functions are assessed at the beginning of the first week, final functions are assessed at the end of the fourth week.)
Change in upper limb functions as assessed by the Box and Block (BBT) test(Baseline functions are assessed at the beginning of the first week, final functions are assessed at the end of the fourth week.)
Change in the active Range of Motion (aROM) for grasping as assessed by a custom robotic assessment(Baseline aROM is assessed at the beginning of the first week, final aROM is assessed at the end of the fourth week.)
Usability as assessed by the NASA Task Load Index(Usability is measured again at the end of the fourth week.)
Change in upper limb functions as assessed by the modified Ashworth Scale (mAS)(Baseline functions are assessed at the beginning of the first week, final functions are assessed at the end of the fourth week.)
Monitoring of muscle tone(First to fourth week.)
Change in knowledge about stroke and health as assessed by a custom questionnaire consisting of 20 open or multiple-choice questions about stroke and health(The baseline assessment is performed at the beginning of the first week, the final assessment is performed at the end of the fourth week.)
Change in hand proprioception as assessed by a custom robotic assessment measuring the minimum difference in length that a patient can perceive(The baseline assessment is performed at the beginning of the first week, the final assessment is performed at the end of the fourth week.)