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)

NCT07182734 | Not Yet Recruiting

• 1 other identifier: RHB Home - RehabCoach
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rehabilitation After Neurological or Orthopaedic Injuries

Keywords

rehabilitation; stroke; traumatic brain injury; robotic devices; unsupervised therapy; hand training; upper limb therapy

Outcome Measures

Primary Outcomes (3)

• Dose of unsupervised therapy - Minutes

  Dose in minutes of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.

  This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).

• Dose of unsupervised therapy - Repetitions

  Daily dose in number of task repetitions of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.

  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

  Percentage increase in therapy time due to the unsupervised robotic therapy compared to the case where the participants would perform conventional (i.e., normally prescribed) therapy only.

  This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).

Secondary Outcomes (45)

• Feasibility - Adverse events

  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

  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 - App deficiencies

  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 - Number of subjects performing unsupervised robot-assisted training

  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).

• Feasibility - Attendance

  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).

Study Arms (2)

ReHandyBot + RehabCoach (neurological)

EXPERIMENTAL

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.

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

ReHandyBot + RehabCoach (orthopaedic)

EXPERIMENTAL

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.

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

Interventions

Supervised and minimally-supervised therapy with ReHandyBot and RehabCoach DEVICE

During the familiarization phase at the rehabilitation clinic, participants perform one week of supervised and one week of minimally-supervised therapy with the ReHandyBot under the supervision of a therapist or researcher. Minimally-supervised therapy means that participants try to perform therapy independently with the device, while the supervisor is present to provide assistance only if problems occur or if participants have questions. A few days after the study begins, participants are introduced to the RehabCoach application, which provides conversational support, reminders, and educational content throughout the intervention. During the supervised and minimally-supervised phases (first 2 weeks), the intervention dose is 5 sessions of approximately 45 minutes per week. These sessions are performed in addition to the conventional therapy plan. In each session, the robot proposes a set of 3 exercises, each lasting between 10 and 15 minutes.

ReHandyBot + RehabCoach (neurological); ReHandyBot + RehabCoach (orthopaedic)

Unsupervised Therapy with ReHandyBot and RehabCoach DEVICE

After the familiarization phase, participants continue training without direct supervision at the clinic until discharge and then at home for six weeks. If the therapist considers the participant capable of training safely and effectively with the device, the participant will keep training with the ReHandyBot unsupervised, both at the clinic and at home, while supported by the RehabCoach application. RehabCoach provides reminders, motivational support, and educational material to guide the home-based therapy. If participants are not considered ready for unsupervised therapy with the device, they will not proceed to the unsupervised phase.

ReHandyBot + RehabCoach (neurological); ReHandyBot + RehabCoach (orthopaedic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Moderate to severe aphasia: Goodglass-Kaplan's scale \< 3.
• Moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) \< 9.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Rehaklinik Bellikon: collaborator

Related Publications (1)

• Devittori, G., Akeddar, M., Retevoi, A., Schneider, F., Cvetkova, V., Dinacci, D., Califfi, A., Rossi, P., Petrillo, C., Kowatsch, T., & Lambercy, O. (2024). Towards RehabCoach: Design and Preliminary Evaluation of a Conversational Agent Supporting Unsupervised Therapy After Stroke. 2024 10th IEEE RAS/EMBS International Conference for Biomedical Robotics and Biomechatronics (BioRob), 569-574. https://doi.org/10.1109/BIOROB60516.2024.10719881

  BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Olivier Lambercy, Prof. Dr.

  Swiss Federal Institute of Technology Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giada Devittori, Dr.

CONTACT

+41 44 510 72 31; giada.devittori@hest.ethz.ch

Alexandra Retevoi

CONTACT

+41 76 745 05 96; alexandra.retevoi@hest.ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 19, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share