NCT04189042

Brief Summary

The aim of study is to assess validity and reliability of Figure-of-Eight Walk Test in people with Parkinson's Disease

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

December 11, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

December 4, 2019

Last Update Submit

February 2, 2021

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Figure-of-Eight Walk Test

    Figure-of-Eight Walk Test involves straight and curved paths in order to assess the advanced walking performance required in daily life.The subject walks a "figure 8" pattern around two cones spaced 5 ft apart, and the time and number of steps needed to complete the assessment are recorded.

    10-15 seconds

Secondary Outcomes (6)

  • Unified Parkinson's Disease Rating Scale

    15 minutes

  • Hoehn and Yahr Scale

    1 minutes

  • Timed Up and Go Test

    10-15 seconds

  • Berg Balance Scale

    10-15 minutes

  • 10 Meter Walk Test

    10-15 seconds

  • +1 more secondary outcomes

Study Arms (2)

Parkinson Group

Patients with Parkinson's Disease (Hoehn and Yahr stage 1-4)

Healthy Control

Healthy People

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Parkinson's Disease who apply to the Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.

You may qualify if:

  • at least 40 years of age
  • neurologist-diagnosed Parkinson's Disease
  • Hoehn \& Yahr (H\&Y) stages 1 to 3
  • able to walk at least 20 meters

You may not qualify if:

  • other neurologic disorder
  • visual, auditory, orientational problems that could affect study results
  • any orthopedic problem that prevents walking and standing
  • have a cardiovascular, pulmonary or hormonal disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University, Faculty of Health Sciences

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 6, 2019

Study Start

December 11, 2019

Primary Completion

March 30, 2021

Study Completion

May 31, 2021

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)