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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Minimally supervised therapy with the ReHapticKnob

• Registration Number: NCT04388891
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-14
• Study Start: 2020-08-11
• Primary Completion: 2023-09-14
• Study Completion: 2023-09-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimally supervised therapy	Minimally supervised therapy with the ReHapticKnob	This group will undergo minimally supervised therapy with the robot ReHapticKnob.

Primary Outcome Measures

Name	Time	Method
Compliance as assessed by dose	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 Outcome Measures

Name	Time	Method
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 between baseline (i.e. beginning of the study) and final (i.e. end of the study) aROM for forearm pronation and supination. This is measured by the robot with a custom assessment.
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.	Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) haptic perception, defined as the minimum difference in stiffness that a patient can perceive. This is measured by the robot with a custom assessment.
Usability as assessed by the System Usability Scale	Usability is measured again at the end of the fourth week.	Usability of the ReHapticKnob measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).
Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale	First to fourth week.	A 5-point scale is presented by the robot at the end of each therapy session to measure patient's satisfaction with robot-assisted therapy.
Usability as assessed by the Post-Study System Usability Questionnaire	Usability is measured again at the end of the fourth week.	Usability of the ReHapticKnob measured with the Post-Study System Usability Questionnaire (version 3). This questionnaire consists of 16 questions and the possible response options vary between 1 (strongly agree) and 7 (strongly disagree).
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 between baseline (i.e. beginning of the study) and final (i.e. end of the study) upper limb functions as assessed by the MESUPES. The scores can vary between 0 and 58, and a higher score means a better outcome.
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 between baseline (i.e. beginning of the study) and final (i.e. end of the study) upper limb functions as assessed by the FMA-UE.
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 between baseline (i.e. beginning of the study) and final (i.e. end of the study) upper limb functions as assessed by the ABILHAND scale.
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 between baseline (i.e. beginning of the study) and final (i.e. end of the study) upper limb functions as assessed by the BBT test.
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.	Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) aROM for grasping, i.e. for hand opening and closing. This is measured by the robot with a custom assessment.
Usability as assessed by the NASA Task Load Index	Usability is measured again at the end of the fourth week.	Usability of the ReHapticKnob measured with the NASA Task Load Index.
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.	Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) upper limb functions as assessed by the mAS.
Monitoring of muscle tone	First to fourth week.	Muscle tone will be monitored throughout the robot-assisted therapy with assessments embedded in some of the exercises implemented in the ReHapticKnob.
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 between baseline (i.e. beginning of the study) and final (i.e. end of the study) knowledge about stroke and health, defined as the number of correct answers out of total number of questions asked about stroke and health. The questionnaire with the 20 questions about stroke and health is custom made.
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.	Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) hand proprioception, defined as the minimum difference in length that a patient can perceive (i.e. just noticeable difference). This is measured by the robot with a custom assessment.

Trial Locations

Locations (1)

Clinica Hildebrand Centro di riabiliazione Brissago; 🇨🇭 Brissago, Ticino, Switzerland