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NCT07182734Not yet recruiting

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)

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): an Exploratory Study

Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
3 Sept 2025
Start date
Sept 2025
Primary completion date
Aug 2028
Lead sponsor
Swiss Federal Institute of Technology
Diseases
Stroke
NCT number
NCT07182734

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From Sept 2025 to the primary completion date, Aug 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Functional impairment of the upper limb due to other pathologies.
  • Functional impairment of the upper limb due to other pathologies.

Other

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

Who the study is looking for

  • 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.
  • 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.

Criteria the registry did not label

  • Eligibility criteria for neurological patients

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.