NCT05109897

Brief Summary

The principal motor features of Parkinson's disease (PD) include rigidity, tremor, bradykinesia, and postural instability. These motor deficits might cause gait dysfunction including reduced gait velocity, stride length, arm swing, and increased gait variability. Among these, increase in gait variability increased fall risk and served as a marker of disease progression. Previous studies reported that some factors might influence gait variability. However, which one contributes most has not yet been verified. Therefore, the purpose of the present study is to identify the more related influencing factors on gait variability in people with PD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

October 13, 2021

Last Update Submit

October 25, 2021

Conditions

Keywords

Parkinson's disease, Gait variability

Outcome Measures

Primary Outcomes (7)

  • Gait variability

    Using GAITRite system to measure coefficient of variation

    10 minutes

  • Walking speed

    Using GAITRite system to evaluate

    10 minutes

  • Sensory organization test

    Using NeuroCom Smart Balance Master to measure

    20 minutes

  • Part III of the Unified Parkinson's Disease Rating Scale

    The score ranged from 0 to 72. Higher scores show increased severity.

    20 minutes

  • Tinetti Balance Scale

    The score ranged from 0 to 28. Higher scores show better balance.

    10 minutes

  • New freezing of gait questionnaire

    The score ranged from 0 to 29. Higher scores show increased severity in freezing of gait.

    15 minutes

  • Montreal Cognitive Assessment

    The score ranged from 0 to 30. Higher scores show better cognitive function.

    20 minutes

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with Parkinson's disease

You may qualify if:

  • Idiopathic PD
  • Hoehn and Yahr stages I through III
  • Ability to stand and walk 5 m independently with or without any walking aids
  • Stable medication usage

You may not qualify if:

  • Unstable medical conditions
  • Any neurological, cardiopulmonary or orthopedic problem/diseases that may interfere with participating the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Yea-Ru Yang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 13, 2021

First Posted

November 5, 2021

Study Start

November 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 5, 2021

Record last verified: 2021-10

Locations