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:
NCT04440033
Eligibility Criteria:
Parkinson's Disease group
Inclusion criteria:
* Persons with idiopathic PD diagnosed by a medical doctor according to the United Kingdom PD Brain Bank Criteria
* Aged between 18 and 75 years-old
* Stage 3 on the Hoehn and Yahr scale in the on-medication state
* On a stable dose of PD medication (at least one week)
* Able to stand and walk on a treadmill without support for at least 3 minutes
* Able to give consent
Exclusion criteria:
* Atypical parkinsonism
* Unpredictable symptom fluctuations
* Previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)
* Duodopa pump therapy
* Dementia (Montreal Cognitive Assessment (MoCA) \< 21)\[1\]
* Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)
* Concurrent neurological disorders (e.g. stroke)
* Comorbidities that affect gait or balance (e.g. peripheral neuropathy)
* Acute illness
* Epilepsy or history of seizures
* Depression (MDS-UPDRS item 1.3 ≥ 2)
* Body weight over 120 kilograms
* Pregnancy
* Participation in other ongoing experimental trials
Healthy control group
Inclusion criteria:
* Age and sex-matched healthy adults
Exclusion criteria:
* Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)
* Body weight over 120 kilograms
* Pregnancy
* Participation in other ongoing experimental trials
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04440033
Study Brief:
Protocol Section:
NCT04440033