Clinical trial NCT04388891: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Hand impairment
Robot-assisted therapy
Minimally supervised therapy
Neurorehabilitation
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Clinica Hildebrand Brissago
name: Rehabilitation Engineering Laboratory, ETHZ
First posted: 2020-05-14
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Compliance as assessed by dose
timeFrame: Compliance to minimally supervised therapy is calculated at the end of the fourth week of the study protocol.
Secondary outcomes:
measure: Usability as assessed by the Post-Study System Usability Questionnaire
timeFrame: Usability is first measured at the end of the second week.
measure: Usability as assessed by the Post-Study System Usability Questionnaire
timeFrame: Usability is measured again at the end of the fourth week.
measure: Usability as assessed by the System Usability Scale
timeFrame: Usability is first measured at the end of the second week.
measure: Usability as assessed by the System Usability Scale
timeFrame: Usability is measured again at the end of the fourth week.
measure: Usability as assessed by the NASA Task Load Index
timeFrame: Usability is first measured at the end of the second week.
measure: Usability as assessed by the NASA Task Load Index
timeFrame: Usability is measured again at the end of the fourth week.
measure: Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale
timeFrame: First to fourth week.
measure: Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)
timeFrame: Baseline functions are assessed at the beginning of the first week, final functions are assessed at the end of the fourth week.
measure: Change in upper limb functions as assessed by the ABILHAND
timeFrame: Baseline functions are assessed at the beginning of the first week, final functions are assessed at the end of the fourth week.
measure: Change in upper limb functions as assessed by the Box and Block (BBT) test
timeFrame: Baseline functions are assessed at the beginning of the first week, final functions are assessed at the end of the fourth week.
measure: Change in upper limb functions as assessed by the Motor Evaluation Scale for Upper Extremities in Stroke Patients (MESUPES)
timeFrame: Baseline functions are assessed at the beginning of the first week, final functions are assessed at the end of the fourth week.
measure: Change in upper limb functions as assessed by the modified Ashworth Scale (mAS)
timeFrame: Baseline functions are assessed at the beginning of the first week, final functions are assessed at the end of the fourth week.
measure: Change in the active Range of Motion (aROM) for grasping as assessed by a custom robotic assessment
timeFrame: Baseline aROM is assessed at the beginning of the first week, final aROM is assessed at the end of the fourth week.
measure: Change in the active Range of Motion (aROM) for forearm rotation as assessed by a custom robotic assessment
timeFrame: Baseline aROM is assessed at the beginning of the first week, final aROM is assessed at the end of the fourth week.
measure: Change in hand proprioception as assessed by a custom robotic assessment measuring the minimum difference in length that a patient can perceive
timeFrame: The baseline assessment is performed at the beginning of the first week, the final assessment is performed at the end of the fourth week.
measure: Change in haptic perception as assessed by a custom robotic assessment measuring the minimum difference in stiffness that a patient can perceive
timeFrame: The baseline assessment is performed at the beginning of the first week, the final assessment is performed at the end of the fourth week.
measure: Monitoring of muscle tone
timeFrame: First to fourth week.
measure: 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
timeFrame: The baseline assessment is performed at the beginning of the first week, the final assessment is performed at the end of the fourth week.
Other outcomes:
Locations:
city: Brissago
country: Switzerland
facility: Clinica Hildebrand Centro di riabiliazione Brissago
state: Ticino
Study officials:
affiliation: Clinica Hildebrand Brissago
name: Paolo Rossi, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: