Factors Associated With Falling in Parkinson's Disease

G

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)

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

Trial contacts and locations

0

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Central trial contact

Nina Lefeber, PhD

Data sourced from clinicaltrials.gov

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