Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot)

Official title

Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot): a Multicentric, Exploratory Study

Overview

The ReHandyBot (RHB) is a robot for hand rehabilitation after stroke. The aims of this study are to investigate (i) the generalizability of unsupervised therapy with the ReHandyBot within patients' home after discharge from a clinic, (ii) compliance, as measured by the amount of unsupervised robot-assisted therapy dose (e.g., therapy time) performed by the subjects after discharge, (iii) the usability of ReHandyBot and user experience during robot-assisted therapy, and (iv) the effect of the increase in therapy dose achieved with our device compared to standard care. The study consists of two primary phases. The first is a familiarization phase conducted at the clinic, where therapists teach participants how to perform the exercises using 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.

Interventions

• Device Supervised and minimally supervised therapy with ReHandyBot
  During the familiarization phase at the rehabilitation clinics, participants perform one week of supervised and one week of minimally supervised therapy with the ReHandyBot under the supervision of a supervisor (i.e., therapist or researcher). Minimally supervised therapy means that participants try to perform therapy with the device themselves, while the supervisor is still present but helps only if participants encounter problems or have questions. During the supervised and minimally supervise
• Device Unsupervised therapy
  After the familiarization phase, participants train without supervision at the clinic until discharge and then at home for six weeks. If the therapist thinks that the participant has properly learned how to use the device and can train with it safely, the participant can keep training with the device unsupervised (both at the clinic and at home). If participants are not ready for unsupervised therapy with the device, they stop the study at the end of the familiarization phase.

Primary outcome measures

• Dose of unsupervised therapy - Minutes [Time frame: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).]
• Dose of unsupervised therapy - Repetitions [Time frame: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).]
• Dose of unsupervised therapy - Percentual change in therapy time [Time frame: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).]

Secondary outcome measures (12)

• Feasibility - Adverse events [Time frame: 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).]
• Feasibility - Device deficiencies [Time frame: 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).]
• Feasibility - Subjects performing unsupervised robot-assisted training [Time frame: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).]
• Feasibility - Attendance [Time frame: This is calculated on completion of the study protocol, i.e., at the end of the six weeks of unsupervised therapy at home.]
• Generalizability of unsupervised therapy with the ReHandyBot [Time frame: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).]
• Usability as assessed by the System Usability Scale (1) [Time frame: This is measured at the end of the second week of intervention (at the end of the familiarization phase).]
• Usability as assessed by the System Usability Scale (2) [Time frame: Usability is measured again after 8 weeks of intervention.]
• Usability as assessed by the raw NASA Task Load Index (1) [Time frame: This is measured at the end of the second week of intervention (at the end of the familiarization phase).]
• Usability as assessed by the raw NASA Task Load Index (2) [Time frame: Usability is measured again after 8 weeks of intervention.]
• Usability as assessed by the Post-Study System Usability Questionnaire (1) [Time frame: This is measured at the end of the second week of intervention (at the end of the familiarization phase).]
• Usability as assessed by the Post-Study System Usability Questionnaire (2) [Time frame: Usability is measured again after 8 weeks of intervention.]
• Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale [Time frame: 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).]

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;
• after discharge the patient will go to an assisted living facility (e.g., care home).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Switzerland · 4 centers

• Rehaklinik Bellikon — Bellikon
• University Hospital, Geneva — Geneva
• Rehaklinik Valens — Valens
• Rehaklinik Zihlschlacht AG — Zihlschlacht

Identifiers

NCT: NCT07674238 · RHB Home SNR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗