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:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT02350556
Eligibility Criteria:
Inclusion Criteria:
\-
For hemiplegic patients:
* Aged between 18-80 years of age, men and women
* Left or right hemispheric sustentoriel stroke :
oIschemic or hemorragic oFirst symptomatic episode or TIA without consequences oBetween one month and one year since the stroke
* Balance standing \> 30 sec without assistance in closed eyes condition
* FAC score included between 3 and 7
* Triceps Spasticity strictly less than 3 on the Modified Ashworth Scale with heel on the ground and an adductor spasticity up to 3 on the same scale.
* Free, informed and written consent signed by the investigator and by the patient or one of his/her relatives (in the case of a patient able to understand the information and to express his/her consent but with motor difficulties resulting in the inability to sign)
For healthy volunteers :
* Aged between 18-85 years of age, men or women, age-matched ( +/- 5 years ) with stroke patients
* Without a balance disorder
* Affiliated to social security
* Free, informed and written consent
Exclusion Criteria:
For hemiplegic patients:
* History of event affecting postural balance (orthopedic, rheumatological, neurological, ENT ...) before the stroke
* Pregnant women
* Patient with tiredness incompatible with the tests and instrumental assessments
* Patients under legal protection (according to French law) and detainees.
* Patients physically or mentally unable of giving informed consent
For healthy volunteers :
* History of event affecting postural balance (orthopedic, rheumatological, neurological, ENT ...)
* Receiving a psychotropic treatment (antidepressant, antipsychotic, anxiolytic)
* Pregnant women
* Within the period of exclusion in the French national register of persons suitable for biomedical research
* Patients under legal protection (according to French law) and detainees.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02350556
Study Brief:
Protocol Section:
NCT02350556