NCT04440033Completed
Factors Associated with Falling in Parkinson's Disease
Factors Associated with Falling in Parkinson's Disease: a Multidisciplinary Prospective Study
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 3 Jun 2020
- Start date
- 12 Oct 2020
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- University Hospital, Ghent
- Diseases
- Parkinson disease
- NCT number
- NCT04440033
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 12 Oct 2020 to the primary completion date, 1 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)
- Duodopa pump therapy
- Concurrent neurological disorders (e.g. stroke)
Other illness
- Dementia (Montreal Cognitive Assessment (MoCA) \< 21)\[1\]
- Acute illness
- Epilepsy or history of seizures
Other
- Atypical parkinsonism
- Unpredictable symptom fluctuations
- Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)
- Comorbidities that affect gait or balance (e.g. peripheral neuropathy)
- Depression (MDS-UPDRS item 1.3 ≥ 2)
- Body weight over 120 kilograms
- Pregnancy
- Participation in other ongoing experimental trials
- Healthy control group
- Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)
- Body weight over 120 kilograms
- Pregnancy
- Participation in other ongoing experimental trials
Who the study is looking for
- 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
- Age and sex-matched healthy adults
Criteria the registry did not label
- Parkinson's Disease group
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ghent University Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.