Feasibility of Unsupervised Therapy After Neurological or Orthopaedical Injury in the Home Settin… (NCT07182734) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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)
30 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose of unsupervised therapy - Minutes
Timeframe: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
2
Dose of unsupervised therapy - Repetitions
Timeframe: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
3
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).