Factors Associated With Falling in Parkinson's Disease

Ghent University Hospital (UZ)

Status: Completed

Conditions: Parkinson Disease

Treatments: Other: Baseline assessment of demographic, anthropometric and clinical characteristics; Other: Speech assessments; Other: Locomotor assessments; Other: Audiology assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT04440033

BC-07392

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Parkinson's Disease group

Experimental group

Description:

Patients with stage 3 idiopathic Parkinson's Disease

Treatment:

Other: Audiology assessments

Other: Locomotor assessments

Other: Speech assessments

Other: Baseline assessment of demographic, anthropometric and clinical characteristics

Healthy control group

Active Comparator group

Description:

Age and sex-matched healthy adults

Treatment:

Other: Audiology assessments

Other: Locomotor assessments

Other: Speech assessments

Other: Baseline assessment of demographic, anthropometric and clinical characteristics