Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT07182734
Eligibility 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07182734
Study Brief:
Protocol Section:
NCT07182734