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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04189042
Other study ID # 2019.19.164
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 11, 2019
Est. completion date May 31, 2021

Study information

Verified date February 2021
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date May 31, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Gazi University, Faculty of Health Sciences Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Unified Parkinson's Disease Rating Scale 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. 15 minutes
Secondary Hoehn and Yahr Scale 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). 1 minutes
Secondary Timed Up and Go Test 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. 10-15 seconds
Secondary Berg Balance Scale Berg Balance Scale (BBS) is a scale that using for assess postural stability. It ranges 0-56 with higher score indicates better stability. 10-15 minutes
Secondary 10 Meter Walk Test 10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance. 10-15 seconds
Secondary Activities-Specific Balance Confidence (ABC) Scale 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). 5 minutes
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