Figure-of-Eight Walk Test in Parkinson

Sponsor
Gazi University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04189042
Collaborator
(none)
30
1
17.6
1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessing Validity and Reliability of Figure-of-Eight Walk Test in People With Parkinson's Disease
    Actual Study Start Date :
    Dec 11, 2019
    Anticipated Primary Completion Date :
    Mar 30, 2021
    Anticipated Study Completion Date :
    May 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Parkinson Group

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

    Healthy Control

    Healthy People

    Outcome Measures

    Primary Outcome Measures

    1. Figure-of-Eight Walk Test [10-15 seconds]

      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.

    Secondary Outcome Measures

    1. Unified Parkinson's Disease Rating Scale [15 minutes]

      The Unified Parkinson's Disease Rating Scale (UPDRS) is a widely used measure of impairment and disability associated with Parkinson's Disease (PD) consisting of four sections: (1) Mentation, behavior, and mood; (2) Activities of daily living (ADLs); (3) Motor; and (4) Complications.Sections I through III are scored using a 5-point Likert-type scale (0 = no impairment; 4 = marked impairment). Although individual sections are scored and reported independently, scores from sections I through III are also summed to provide a UPDRS Total score. The UPDRS total score ranges between 0 and 199 points. Higher points indicates worse outcome.

    2. Hoehn and Yahr Scale [1 minutes]

      Disease stage is assessed by the Hoehn and Yahr Scale. The Hoehn and Yahr scale is a commonly used diagnostic tool for quantifying the progression of Parkinson's Disease symptoms. Stages range from 0 (no signs of disease) to 5 (requiring a wheelchair, or bedridden unless assisted).

    3. Timed Up and Go Test [10-15 seconds]

      Functional mobility is assessed by using the timed up and go test. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.

    4. Berg Balance Scale [10-15 minutes]

      Berg Balance Scale (BBS) is a scale that using for assess postural stability. It ranges 0-56 with higher score indicates better stability.

    5. 10 Meter Walk Test [10-15 seconds]

      10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance.

    6. Activities-Specific Balance Confidence (ABC) Scale [5 minutes]

      Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady.The ABC scale is a self-reported questionnaire providing information on balance confidence in the performance of 16 different daily activities, such as stair climbing, walking in the house, and walking on slippery floors. The questionnaire contains 16 items scored on a range from 0% to 100% (0 indicating no confidence and 100 indicating full confidence).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gazi University, Faculty of Health Sciences Ankara Turkey 06560

    Sponsors and Collaborators

    • Gazi University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Çağrı Gülşen, Principal Investigator, Gazi University
    ClinicalTrials.gov Identifier:
    NCT04189042
    Other Study ID Numbers:
    • 2019.19.164
    First Posted:
    Dec 6, 2019
    Last Update Posted:
    Feb 4, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2021