Feasibility of Unsupervised Therapy After Neurological or Orthopaedical Injury in the Home Setting With a Hand Rehabilitation Device (ReHandyBot) and an Assistive Smartphone Application (RehabCoach)

Federal Institute of Technology (ETH) Zurich

Status: Not yet enrolling

Conditions: Rehabilitation After Neurological or Orthopaedic Injuries

Treatments: Device: Unsupervised Therapy with ReHandyBot and RehabCoach; Device: Supervised and minimally-supervised therapy with ReHandyBot and RehabCoach

Study type: Interventional

Funder types: Other

Identifiers

NCT07182734

RHB Home - RehabCoach

Details and patient eligibility

About

The goal of this clinical trial is to evaluate whether using the ReHandyBot hand rehabilitation device together with the RehabCoach smartphone app can support safe, independent, and effective home therapy in patients with stroke, traumatic brain injury, or orthopedic problems.

The main questions it aims to answer are:

• Can patients safely and independently use ReHandyBot and RehabCoach after leaving the clinic?
• Will patients follow the recommended daily therapy schedule when using these tools at home?
• How do patients experience the usability and acceptability of ReHandyBot and RehabCoach in everyday life?
• Can this type of home-based therapy be extended to populations beyond stroke, such as traumatic brain injury and orthopedic patients?

Participants will:

• Complete a screening and baseline assessment with a therapist.
• Use ReHandyBot in a supervised phase at the clinic (3 sessions of 30 minutes).
• Continue with a minimally supervised phase at the clinic (3-7 sessions of 30 minutes, with daily app use).
• If ready, enter the unsupervised phase, taking ReHandyBot home for daily 30-minute training sessions, supported by RehabCoach.
• Return for a final assessment including clinical and robotic evaluations and usability feedback.

Full description

Many neurological (e.g., stroke, traumatic brain injury) and orthopedic patients do not fully recover hand function, with a consequent decrease in independence and quality of life. Growing evidence shows that increasing the dose of upper limb therapy for in- and outpatients could improve functional outcomes. However, due to limited resources such as the low number of therapists, providing a higher dose of therapy to patients after discharge is highly challenging.

Unsupervised technology-assisted therapy, i.e., patients training with rehabilitation technologies without external supervision or intervention, may allow an increase in therapy dose (in clinical settings and at home) with little impact on the additional resources needed.

At the Rehabilitation Engineering Laboratory (RELab, ETH Zurich) we developed ReHandyBot, a portable device for hand rehabilitation. ReHandyBot was developed for unsupervised application in the home setting and preliminary results of an ongoing study show that stroke patients can learn how to use the device independently and bring it home to keep training with it after discharge from the clinic, increasing their therapy dose. However, during the unsupervised phase at home, patients' adherence to the recommended dose of therapy with ReHandyBot (i.e., at least one therapy session per day) was not always optimal.

At home, without the supervision of healthcare providers, patients often experience a decline in motivation and engagement over time. To address this, we developed RehabCoach, a smartphone application designed to support unsupervised therapy with ReHandyBot. RehabCoach incorporates chatbots (i.e., conversations with virtual assistants) and gamification elements designed to enhance therapy adherence. Until now, RehabCoach has been tested in some pilot usability studies, but a more extended evaluation has not been performed yet.

This study, therefore, investigates the use of ReHandyBot supported by RehabCoach at the homes of patients with stroke, traumatic brain injury, or orthopedic issues. The main objectives of this study are therefore to investigate (i) the feasibility of unsupervised therapy with ReHandyBot and RehabCoach within patients' home after discharge from the clinic, (ii) compliance to the therapy schedule after discharge, (iii) the usability of ReHandyBot and RehabCoach and user experience when using them, and (iv) the feasibility of extending therapy with ReHandyBot to populations other than stroke (i.e., patients with orthopedic problems or traumatic brain injury).

Sex and gender are not relevant for this study, as we do not expect the feasibility of using the device without supervision to be dependent on them.

The primary objective of this study is to investigate feasibility of unsupervised home therapy with the ReHandyBot supported by RehabCoach and to determine subjects' compliance to unsupervised robot-assisted therapy in the home setting as measured by the amount of self-administered dose of therapy with ReHandyBot.

Main secondary objectives comprise the evaluation of usability of ReHandyBot and RehabCoach and of user experience during robot-assisted therapy and when using the app, the feasibility of extending therapy with ReHandyBot to individuals with traumatic brain injury or orthopedic injury, functional recovery of the upper limb, parameters possibly influencing the use of ReHandyBot and RehabCoach, the impact of the goal and reward systems implemented on RehabCoach on motivation to train with ReHandyBot, as well as the feasibility and usability of the educational program delivered by the app.

The primary outcome of this study is the dose (e.g., therapy time, number of repetitions) of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.

Main secondary outcomes are the number of subjects who can use ReHandyBot and RehabCoach unsupervised at home out of the total number of tested subjects, attendance to the therapy schedule during the unsupervised phase at home, adherence to the interactions required by RehabCoach, the number of times and reasons why the investigators need to intervene to help participants with eventual issues during the phase at home, safety, usability of ReHandyBot and RehabCoach and user experience (System Usability Scale, mHealth App Usability Questionnaire for RehabCoach, Customer Satisfaction Score, Net Promoter Score, open interview, etc.), number of additional therapy sessions initiated by the patients compared to the minimum recommendations, functional recovery.

Participants will receive robot-assisted therapy sessions with the ReHandyBot in parallel to their conventional therapy program for a period of around nine weeks. Additionally, they will interact with an app, RehabCoach, which will motivate patients to maximize the amount of training they perform with ReHandyBot.

This study consists of the following phases:

• Preparation phase: This phase includes a screening visit and an evaluation session with a therapist to perform baseline clinical assessments.
• Supervised phase: During the first week, subjects perform 3 sessions of 30 minutes of therapy with ReHandyBot supervised by a therapist or researcher. This phase is performed at the clinic and is used to familiarize the subject with the rehabilitation device. Additionally, the participants are also introduced to RehabCoach.
• Minimally supervised phase: During the second week, subjects interact with RehabCoach daily and perform 3-7 sessions of 30 minutes of minimally supervised therapy with the device at the clinic. The supervisor is still present but helps only in case patients encounter problems or if they have any questions. At the end of this phase, the supervisor uses a checklist to determine if the subject can proceed to the unsupervised phase. If not, the participant stops the study at the end of the minimally supervised phase. At the end of the minimally supervised phase, subjects need to fill in some questionnaires to rate the usability of ReHandyBot and RehabCoach.
• Unsupervised phase: If patients are ready for unsupervised training, during the unsupervised phase they take the ReHandyBot home and have the opportunity to independently exercise with the robot, with the recommendation of training at least 30 minutes per day (i.e., one complete therapy session per day) but also informing them that the more they train, the better. Patients who can use RehabCoach at home will also continue with the daily interactions with the app.
• Final phase: At the end of the protocol, subjects repeat the clinical and robotic assessments and the usability evaluation.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility criteria for neurological patients

Inclusion criteria:

• Informed Consent signed by the subject.
• Female and male patients between 18 and 90 years old.
• Stroke or traumatic brain injury (recruitment within 6 months from event onset).
• Presence of a motor and/or sensory impairment of the upper limb as assessed by the responsible therapist.
• 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).

Eligibility criteria for orthopedic patients

Inclusion criteria:

• Informed Consent signed by the subject.
• Female and male patients between 18 and 90 years old.
• Clinic stay due to an orthopedic-related condition (e.g., surgery, trauma, burns).
• Presence of a motor and/or sensory impairment of the upper limb as assessed by the responsible therapist.
• Possibility (e.g., enough space) to set up the ReHandyBot at home.

Exclusion criteria:

• 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).

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

ReHandyBot + RehabCoach (neurological)

Experimental group

Description:

Participants will use the ReHandyBot hand rehabilitation device together with the RehabCoach smartphone app. All participants will: * Complete a preparation phase with screening and baseline clinical assessments. * Perform 3 supervised 30-minute training sessions with ReHandyBot in the clinic. * Perform 3-7 minimally supervised 30-minute training sessions in the clinic, with daily use of RehabCoach. * If ready, continue into an unsupervised phase, taking ReHandyBot home for daily training (recommended at least 30 minutes per day), supported by RehabCoach. * Return for a final evaluation including clinical and robotic assessments and usability feedback.

Treatment:

Device: Unsupervised Therapy with ReHandyBot and RehabCoach

Device: Supervised and minimally-supervised therapy with ReHandyBot and RehabCoach

ReHandyBot + RehabCoach (orthopaedic)

Experimental group

Description:

Participants will use the ReHandyBot hand rehabilitation device together with the RehabCoach smartphone app. All participants will: * Complete a preparation phase with screening and baseline clinical assessments. * Perform 3 supervised 30-minute training sessions with ReHandyBot in the clinic. * Perform 3-7 minimally supervised 30-minute training sessions in the clinic, with daily use of RehabCoach. * If ready, continue into an unsupervised phase, taking ReHandyBot home for daily training (recommended at least 30 minutes per day), supported by RehabCoach. * Return for a final evaluation including clinical and robotic assessments and usability feedback.

Treatment:

Device: Unsupervised Therapy with ReHandyBot and RehabCoach

Device: Supervised and minimally-supervised therapy with ReHandyBot and RehabCoach