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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT00719433
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or more
* first-ever stroke (hemorrhagic or ischemic), verified by brain imaging
* stroke more than six months prior to the study
* termination of conventional therapy and stable recovery stage (outpatients)
* moderate to severe motor impairment of the arm (upper limb portion of FMA score between 8 and 38)
* ability to sit in a chair without any additional support and without leaning on the back rest
* written informed consent signed by the subject (or an authorized representative)
Exclusion Criteria:
* Excessive spasticity of the affected arm (mAS ≥ 3)
* any serious medical or psychiatric illness
* participation in any clinical investigation within 4 weeks prior to the start of this study
* anticipated need for any major surgery during the study
* women known to be pregnant or lactating
* Orthopedic, rheumatologic or other disease restricting movements of the paralyzed upper extremity
* shoulder subluxation (palpatory \> 2 fingers)
* diseased or damaged skin at the paralyzed arm
* inability to communicate effectively with the neurological examiner such that the validity of the patient's data could be compromised
* cyber sickness
* pace-maker or other implanted electric devices
* body weight \> 120kg
* serious cognitive deficits and aphasia preventing the performance of the ARMin treatment
* participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00719433
Study Brief:
Protocol Section:
NCT00719433