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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01746433
Eligibility Criteria:
Inclusion Criteria:
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient must be in stable medical condition (no complications for the last 10 days)
* The patient is incapable of changing from a laying position to a sitting position by his/herself in \<10 secondes, and requires help for such movement
* The patient has a sitting-balance score \> 2/4 (Brun et al 1991: Actual Rééduc Réadaptat: (16):412-7))
Exclusion Criteria:
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient has fractured vertebrae or pelvis
* The patient has a weak heart
* The patient has joint pain localized to the dorso-lumbar region
* The patient has behavioral disorders (opposition, agitation, dementia)
* The patient has a medical prescription for physical restraint by bed rails.
* The patient is incapable of understanding the utility of the proposed technical aide, and using it for rolling and sitting up (notion of compliance).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01746433
Study Brief:
Protocol Section:
NCT01746433