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Figure-of-Eight Walk Test in Parkinson

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04189042
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Çağrı Gülşen, Gazi University

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
Parkinson Disease

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Assessing Validity and Reliability of Figure-of-Eight Walk Test in People With Parkinson's Disease
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 7, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Parkinson Group
Patients with Parkinson's Disease (Hoehn and Yahr stage 1-4)
Healthy Control
Healthy People



Primary Outcome Measures :
  1. Figure-of-Eight Walk Test [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04189042


Contacts
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Contact: Çağrı Gülşen, MSc 05555874415 fztcagri@gmail.com

Locations
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Turkey
Gazi University, Faculty of Health Sciences Recruiting
Ankara, Turkey, 06560
Contact: Çağrı Gülşen    05555874415    fztcagri@gmail.com   
Sponsors and Collaborators
Gazi University

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Responsible Party: Çağrı Gülşen, Principal Investigator, Gazi University
ClinicalTrials.gov Identifier: NCT04189042    
Other Study ID Numbers: 2019.19.164
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases