StrokeNCT04388891

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

A study testing Minimally supervised therapy with the ReHapticKnob in people with Stroke, run by Swiss Federal Institute of Technology at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Stroke
What is being tested?: Minimally supervised therapy with the ReHapticKnob
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteSwitzerland
Study dates: 11 Aug 2020to 14 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Clinica Hildebrand Centro di riabiliazione Brissago
Brissago, Canton Ticino, 6614

Other trials in Switzerland

About this study

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

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.

Conditions: Stroke
Being tested: Minimally supervised therapy with the ReHapticKnob
Keywords: Stroke, Hand impairment, Robot-assisted therapy, Minimally supervised therapy, Neurorehabilitation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Minimally supervised therapy with the ReHapticKnobDevice
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.

Study groups in NCT04388891
Study group	Role	What they receive
Minimally supervised therapy	Experimental	This group will undergo minimally supervised therapy with the robot ReHapticKnob. Receives: Device: Minimally supervised therapy with the ReHapticKnob

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (18)

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The baseline assessment is performed at the beginning of the first week, the final assessment is performed at the end of the fourth week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 202014 Sep 2023

First posted14 May 2020
Study start11 Aug 2020
Primary completion14 Sep 2023
Study completion14 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04388891
Sponsor's protocol ID: ReHapticKnob 2020
Status last verified: Feb 2024
First submitted: 5 May 2020
Last updated: 22 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Devittori G, Dinacci D, Romiti D, Califfi A, Petrillo C, Rossi P, Ranzani R, Gassert R, Lambercy O. Unsupervised robot-assisted rehabilitation after stroke: feasibility, effect on therapy dose, and user experience. J Neuroeng Rehabil. 2024 Apr 9;21(1):52. doi: 10.1186/s12984-024-01347-4.
PubMed 38594727
Devittori G, Ranzani R, Dinacci D, Romiti D, Califfi A, Petrillo C, Rossi P, Gassert R, Lambercy O. Progressive Transition From Supervised to Unsupervised Robot-Assisted Therapy After Stroke: Protocol for a Single-Group, Interventional Feasibility Study. JMIR Res Protoc. 2023 Nov 9;12:e48485. doi: 10.2196/48485.
PubMed 37943580

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Feasibility of Minimally Supervised Therapy After Stroke With a Hand Rehabilitation Robot (ReHapticKnob): Pilot and Main Study
ClinicalTrials.gov ID: NCT04388891
Acronym / sponsor ID: ReHapticKnob 2020
Conditions: Stroke
Keywords: Stroke, Hand impairment, Robot-assisted therapy, Minimally supervised therapy, Neurorehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Swiss Federal Institute of TechnologyUniversity, hospital or other
Collaborators: Clinica Hildebrand Brissago, Rehabilitation Engineering Laboratory, ETHZ
Study start: 11 Aug 2020 (actual)
Primary completion: 14 Sep 2023 (actual)
Study completion: 14 Sep 2023 (actual)
First posted: 14 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Minimally supervised therapy	Experimental	Device: Minimally supervised therapy with the ReHapticKnobThis group will undergo minimally supervised therapy with the robot ReHapticKnob.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Minimally supervised therapy with the ReHapticKnobThe 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.	Device	Minimally supervised therapy

Primary outcome

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.

18 secondary outcomes

Usability as assessed by the Post-Study System Usability Questionnaire
Time frame: Usability is first measured at the end of the second week.
Usability as assessed by the Post-Study System Usability Questionnaire
Time frame: Usability is measured again at the end of the fourth week.
Usability as assessed by the System Usability Scale
Time frame: Usability is first measured at the end of the second week.
Usability as assessed by the System Usability Scale
Time frame: Usability is measured again at the end of the fourth week.
Usability as assessed by the NASA Task Load Index
Time frame: Usability is first measured at the end of the second week.
Usability as assessed by the NASA Task Load Index
Time frame: 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
Time frame: First to fourth week.
Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The baseline assessment is performed at the beginning of the first week, the final assessment is performed at the end of the fourth week.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
Derived from this study: PubMed 38594727Devittori G, Dinacci D, Romiti D, Califfi A, Petrillo C, Rossi P, Ranzani R, Gassert R, Lambercy O. Unsupervised robot-assisted rehabilitation after stroke: feasibility, effect on therapy dose, and user experience. J Neuroeng Rehabil. 2024 Apr 9;21(1):52. doi: 10.1186/s12984-024-01347-4.
Derived from this study: PubMed 37943580Devittori G, Ranzani R, Dinacci D, Romiti D, Califfi A, Petrillo C, Rossi P, Gassert R, Lambercy O. Progressive Transition From Supervised to Unsupervised Robot-Assisted Therapy After Stroke: Protocol for a Single-Group, Interventional Feasibility Study. JMIR Res Protoc. 2023 Nov 9;12:e48485. doi: 10.2196/48485.
Individual participant dataSharing planned: No

Related trials for Stroke

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Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paolo Rossi, Dr. med. principal investigator

Clinica Hildebrand Brissago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Minimally supervised therapy with the ReHapticKnob in people with Stroke, run by Swiss Federal Institute of Technology at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04388891, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.