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

Primary Purpose

Stroke

Status

Active

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Minimally supervised therapy with the ReHapticKnob

About this trial

This is an interventional other trial for Stroke focused on measuring Stroke, Hand impairment, Robot-assisted therapy, Minimally supervised therapy, Neurorehabilitation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Clinica Hildebrand Centro di riabiliazione Brissago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minimally supervised therapy

Arm Description

This group will undergo minimally supervised therapy with the robot ReHapticKnob.

Outcomes

Primary Outcome Measures

Compliance as assessed by dose

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

Secondary Outcome Measures

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 as assessed by the Post-Study System Usability Questionnaire

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 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 as assessed by the NASA Task Load Index

Usability of the ReHapticKnob measured with the NASA Task Load Index.

Usability as assessed by the NASA Task Load Index

Usability of the ReHapticKnob measured with the NASA Task Load Index.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04388891

First Posted

May 5, 2020

Last Updated

September 12, 2023

Sponsor

Swiss Federal Institute of Technology

Collaborators

CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO, Rehabilitation Engineering Laboratory, ETHZ

1. Study Identification

Unique Protocol Identification Number

NCT04388891

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 11, 2020 (Actual)

Primary Completion Date

August 14, 2023 (Actual)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Federal Institute of Technology

Collaborators

CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO, Rehabilitation Engineering Laboratory, ETHZ

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, Hand impairment, Robot-assisted therapy, Minimally supervised therapy, Neurorehabilitation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Minimally supervised therapy

Arm Type

Experimental

Arm Description

This group will undergo minimally supervised therapy with the robot ReHapticKnob.

Intervention Type

Device

Intervention Name(s)

Minimally supervised therapy with the ReHapticKnob

Intervention Description

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.

Primary Outcome Measure Information:

Title

Compliance as assessed by dose

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Usability as assessed by the Post-Study System Usability Questionnaire

Description

Time Frame

Usability is first measured at the end of the second week.

Title

Usability as assessed by the Post-Study System Usability Questionnaire

Description

Time Frame

Usability is measured again at the end of the fourth week.

Title

Usability as assessed by the System Usability Scale

Description

Usability of the ReHapticKnob measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).

Time Frame

Usability is first measured at the end of the second week.

Title

Usability as assessed by the System Usability Scale

Description

Usability of the ReHapticKnob measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).

Time Frame

Usability is measured again at the end of the fourth week.

Title

Usability as assessed by the NASA Task Load Index

Description

Usability of the ReHapticKnob measured with the NASA Task Load Index.

Time Frame

Usability is first measured at the end of the second week.

Title

Usability as assessed by the NASA Task Load Index

Description

Usability of the ReHapticKnob measured with the NASA Task Load Index.

Time Frame

Usability is measured again at the end of the fourth week.

Title

Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale

Description

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.

Time Frame

First to fourth week.

Title

Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)

Description

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.

Time Frame