Status:
NOT_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)
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
Rehaklinik Bellikon
Conditions:
Rehabilitation After Neurological or Orthopaedic Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
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 the...
Detailed 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 sh...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07182734
Start Date
September 15 2025
End Date
August 1 2028
Last Update
September 19 2025
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