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 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT03843268
Eligibility Criteria:
Inclusion criteria:
* Patients with clinically chronic and stable PD, confirmed according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBC);
* Age 45 and older;
* Hoehn \& Yahr (H\&Y) stage equal or higher than 2 in ON state;
* Ability to walk autonomously or with minimal assistance for a 10 meters' distance in OFF state;
* Antiparkinsonian treatment at a stable and optimized daily dosage during the 4 weeks prior to the study.
Exclusion criteria
* Any advanced, severe or unstable disease other than PD, which may interfere with the primary and secondary study outcome evaluations (autonomic dysfunction, diabetes, renal or hepatic failure, neoplasia, balance and gait problems of other origin).
* Cognitive impairment with MoCA \< 18
* Any peripheral neurological or musculoskeletal conditions that may alter balance and/or gait.
* Severe lower limb injuries in the previous 6 months.
* History of neurosurgery or orthopedic surgery.
* History of epilepsy.
* Any drug treatment not intended to treat PD that may alter cognitive and/or motor performance.
* History of depression or other psychiatric disorders.
* Severe obesity defined as a BMI greater than 35.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT03843268
Study Brief:
Protocol Section:
NCT03843268