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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Minimally supervised therapy with the ReHapticKnob

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Ticino
    • Brissago, Ticino, Switzerland, 6614
      • Clinica Hildebrand Centro di riabiliazione Brissago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Minimally supervised therapy; This group will undergo minimally supervised therapy with the robot ReHapticKnob.

Device: Minimally supervised therapy with the ReHapticKnob; The therapy with the ReHapticKnob is performed in the clinic in addition to the conventional therapy. During the supervised and semi-supervised phases (first 2 weeks), the intervention dose is 5 sessions of approximately 45 minutes per week. During each session, the robot proposes a set of 3 exercises, each lasting between 10 and 15 minutes. During the minimally supervised phase (third and fourth week), the duration of the ReHapticKnob therapy is not specified, since the patient can decide by him/herself when to use the device, e.g. during freetime or during the weekend.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance as assessed by dose	Sum of the dose of robot-assisted therapy without direct supervision that the patient performs.	Compliance to minimally supervised therapy is calculated at the end of the fourth week of the study protocol.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability as assessed by the Post-Study System Usability Questionnaire	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).	Usability is first measured at the end of the second week.
Usability as assessed by the Post-Study System Usability Questionnaire	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).	Usability is measured again at the end of the fourth week.
Usability as assessed by the System Usability Scale	Usability of the ReHapticKnob measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).	Usability is first measured at the end of the second week.
Usability as assessed by the System Usability Scale	Usability of the ReHapticKnob measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).	Usability is measured again at the end of the fourth week.
Usability as assessed by the NASA Task Load Index	Usability of the ReHapticKnob measured with the NASA Task Load Index.	Usability is first measured at the end of the second week.
Usability as assessed by the NASA Task Load Index	Usability of the ReHapticKnob measured with the NASA Task Load Index.	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	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.	First to fourth week.
Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)	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.	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	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.	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	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.	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 Motor Evaluation Scale for Upper Extremities in Stroke Patients (MESUPES)	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.	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 modified Ashworth Scale (mAS)	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.	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	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.	Baseline aROM is assessed at the beginning of the first week, final aROM is assessed at the end of the fourth week.
Change in the active Range of Motion (aROM) for forearm rotation as assessed by a custom robotic assessment	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.	Baseline aROM is assessed at the beginning of the first week, final aROM is assessed 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	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.	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 haptic perception as assessed by a custom robotic assessment measuring the minimum difference in stiffness that a patient can perceive	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.	The baseline assessment is performed at the beginning of the first week, the final assessment is performed at the end of the fourth week.
Monitoring of muscle tone	Muscle tone will be monitored throughout the robot-assisted therapy with assessments embedded in some of the exercises implemented in the ReHapticKnob.	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	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.	The baseline assessment is performed at the beginning of the first week, the final assessment is performed at the end of the fourth week.

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO; Rehabilitation Engineering Laboratory, ETHZ
• Investigators: Principal Investigator: Paolo Rossi, Dr. med., Clinica Hildebrand Centro di riabilitazione Brissago

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Neurorehabilitation; Hand impairment; Robot-assisted therapy; Minimally supervised therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ReHapticKnob 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No