Skip to main content
OpenTrials
Completed

NCT Number: NCT04388891

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Hildebrand Centro di riabiliazione Brissago

Brissago, Canton Ticino, 6614, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minimally supervised therapy with the ReHapticKnob

Device

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 outcomes

  1. 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

  1. Usability as assessed by the Post-Study System Usability Questionnaire

    Time frame: Usability is first measured at the end of the second 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).

  2. Usability as assessed by the Post-Study System Usability Questionnaire

    Time frame: 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).

  3. Usability as assessed by the System Usability Scale

    Time frame: Usability is first measured at the end of the second week.

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

  4. Usability as assessed by the System Usability Scale

    Time frame: 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).

  5. Usability as assessed by the NASA Task Load Index

    Time frame: Usability is first measured at the end of the second week.

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

  6. Usability as assessed by the NASA Task Load Index

    Time frame: Usability is measured again at the end of the fourth week.

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

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

    Time frame: 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.

  8. 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 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.

  9. 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 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.

  10. 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 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.

  11. 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 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.

  12. 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 between baseline (i.e. beginning of the study) and final (i.e. end of the study) upper limb functions as assessed by the mAS.

  13. 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 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.

  14. 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 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.

  15. 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 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.

  16. 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.

    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.

  17. Monitoring of muscle tone

    Time frame: 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.

  18. 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.

    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.

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Clinica Hildebrand Brissago
  • Rehabilitation Engineering Laboratory, ETHZ

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 14, 2020
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.