Clinical trial NCT06057129: Unsupervised Therapy After Stroke in the Home Setting with a Hand Rehabilitation Device (ReHandyBot)
Official title: Feasibility of Unsupervised Therapy After Stroke in the Home Setting with a Hand Rehabilitation Device (ReHandyBot): an Exploratory Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Hand impairment
Robot-assisted therapy
Unsupervised therapy
Neurorehabilitation
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Clinica Hildebrand Brissago
First posted: 2023-09-28
Enrollment: 15
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: DEVICE_FEASIBILITY

Brief summary: The ReHandyBot is a robot for hand rehabilitation after stroke. The aims of this study are (1) to investigate the feasibility of unsupervised therapy with the ReHandyBot with stroke inpatients, first in a rehabilitation clinic and then at participants' home, (2) to evaluate the usability of the ReHandyBot (user interface, implemented exercises, and gaming environment, which were adapted for independent usage), and (3) to quantify the dose of additional robotic therapy that patients perform without supervision.

The study consists of two primary phases. The first is a familiarization phase performed at the clinic, where therapists teach to the participants how to perform the exercises with the robot. Then, if capable of training with the robot safely, after discharge from the clinic participants can bring the robot home and autonomously train with it. The hypothesis is that unsupervised 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:

* Informed Consent signed by the subject;
* female and male patients between 18 and 90 years old;
* acute/subacute stroke (recruitment within 12 weeks from stroke onset);
* pre-stroke modified Rankin score ≤ 1;
* National Institutes of Health Stroke Scale (NIHSS) ≥ 1 in at least one of the items regarding motor functions, sensory functions and ataxia;
* possibility (e.g., enough space) to set up the ReHandyBot at home.

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's scale \< 3;
* moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) \< 9;
* 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;
* after discharge the patient will go to an assisted living facility (e.g., care home).

Primary outcomes:
measure: Dose of unsupervised therapy - Minutes
timeFrame: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
measure: Dose of unsupervised therapy - Repetitions
timeFrame: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
measure: Dose of unsupervised therapy - Percentual change in therapy time
timeFrame: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Secondary outcomes:
measure: Feasibility - Adverse events
timeFrame: This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
measure: Feasibility - Device deficiencies
timeFrame: This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
measure: Feasibility - Subjects performing unsupervised robot-assisted training
timeFrame: This is calculated on completion of the study (i.e., right after last subject - last visit).
measure: Feasibility - Attendance
timeFrame: This is calculated on completion of the study protocol.
measure: Usability as assessed by the System Usability Scale (1)
timeFrame: This is measured during the intervention (at the end of the familiarization phase).
measure: Usability as assessed by the System Usability Scale (2)
timeFrame: Usability is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Usability as assessed by the raw NASA Task Load Index (1)
timeFrame: This is measured during the intervention (at the end of the familiarization phase).
measure: Usability as assessed by the raw NASA Task Load Index (2)
timeFrame: Usability is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Usability as assessed by the Post-Study System Usability Questionnaire (1)
timeFrame: This is measured during the intervention (at the end of the familiarization phase).
measure: Usability as assessed by the Post-Study System Usability Questionnaire (2)
timeFrame: Usability is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale
timeFrame: This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
measure: Usability - Intrinsic Motivation Inventory (1)
timeFrame: This is measured during the intervention (at the end of the familiarization phase).
measure: Usability - Intrinsic Motivation Inventory (2)
timeFrame: User experience is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Change in usability metrics (i.e., System Usability Scale, NASA Task Load Index, Post-Study System Usability Questionnaire, and Intrinsic Motivation Inventory)
timeFrame: This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: User experience - Customer Satisfaction Score (1)
timeFrame: This is measured during the intervention (at the end of the familiarization phase).
measure: User experience - Customer Satisfaction Score (2)
timeFrame: User experience is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: User experience - Net Promoter Score (1)
timeFrame: This is measured during the intervention (at the end of the familiarization phase).
measure: User experience - Net Promoter Score (2)
timeFrame: User experience is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Change in the user experience metrics (i.e., Customer Satisfaction Score and Net Promoter Score)
timeFrame: This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)
timeFrame: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Change in upper limb functions as assessed by the ABILHAND
timeFrame: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Change in upper limb functions as assessed by the Box and Block (BBT) test
timeFrame: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Change in upper limb functions as assessed by the Motor Evaluation Scale for Upper Extremities in Stroke Patients (MESUPES)
timeFrame: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Change in upper limb functions as assessed by the modified Ashworth Scale (mAS)
timeFrame: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Change in the active Range of Motion (aROM) for grasping measured in millimeters as assessed by the custom robotic assessment "aROM - Hand"
timeFrame: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Change in the active Range of Motion (aROM) for forearm rotation measured in degrees as assessed by the custom robotic assessment "aROM - Forearm"
timeFrame: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Change in proprioception as assessed by the custom robotic assessment "JND" measuring the minimum difference in length (mm) and/or angle (degrees) that a patient can perceive
timeFrame: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Change in haptic perception as assessed by the custom robotic assessment "Weber Fraction" measuring the minimum difference in stiffness that a patient can perceive in percentage
timeFrame: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
measure: Content of robotic therapy - Intensity
timeFrame: This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
measure: Content of robotic therapy - Performance
timeFrame: This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
measure: Content of robotic therapy - Effective time ratio
timeFrame: This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
measure: Parameters influencing unsupervised robot-assisted therapy
timeFrame: This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).
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: