Factors Associated with Falling in Parkinson's Disease (NCT04440033) | Clinical Trial Compass
CompletedNot Applicable
Factors Associated with Falling in Parkinson's Disease
Belgium10 participantsStarted 2020-10-12
Plain-language summary
The objective of this study will be to identify multidisciplinary fall risk factors in persons with stage 3 idiopathic Parkinson's Disease compared to age and sex-matched healthy adults. Both the relative contribution of each independent factor, as well as the interaction between these factors, will be examined. The study will include multidisciplinary assessments, including locomotor, speech, auditory, vestibular and opthalmologic assessments.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.