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The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03587168
Recruitment Status : Not yet recruiting
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Fatih Söke, Gazi University

Brief Summary:
Difficulty in turning is common after Parkinson's Disease. Patients with Parkinson's Disease take a greater number of steps, longer duration, narrower base of support in turning. Thus, turning ability is systematically investigated in Parkinson's Disease. The aim of this study to invastigate reliability, validity, and responsiveness of the timed 360° turn test in Patients with Parkinson's Disease.

Condition or disease Intervention/treatment
Parkinson Disease Other: the timed 360° turn test Other: Berg Balance Scale Other: Four Square Step Test Other: Functional Reach Test Other: Trunk Impairment Scale Other: Timed Up and Go Test Other: Hoehn and Yahr Scale Other: Unified Parkinson's Disease Rating Scale

Detailed Description:
At baseline, the timed 360° turn test, Unified Parkinson's Disease Rating Scale, Hoehn and Yahr Scale, Berg Balance Scale, Functional Reach Test, Timed Up and Go Test, Four Square Step Test and Trunk Impairment Scale was applied to the patients with Parkinson's Disease when the patients were "on" period. The timed 360° turn test was repeated after seven days from the first application when patients with Parkinson's Disease were "on" period to evaluate its reliability.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's Disease
Estimated Study Start Date : July 20, 2018
Estimated Primary Completion Date : August 10, 2018
Estimated Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with Parkinson's Disease
Patients with Parkinson's Disease Parkinson's Disease (Hoehn and Yahr stage 1-4)
Other: the timed 360° turn test
Turning ability is assessed by using the timed 360° turn test.

Other: Berg Balance Scale
Functional balance is assessed by using the Berg Balance Scale.

Other: Four Square Step Test
The Four Square Step Test measures dynamic balance.

Other: Functional Reach Test
The Functional Reach Test assesses limits of stability.

Other: Trunk Impairment Scale
Trunk performance is assessed by using the trunk impairment scale.

Other: Timed Up and Go Test
Functional mobility is assessed by using the timed up and go test.

Other: Hoehn and Yahr Scale
Disease stage is assessed by the Hoehn and Yahr Scale.

Other: Unified Parkinson's Disease Rating Scale
The Unified Parkinson's Disease Rating Scale assesses disease severity.

Healthy Controls
Healthy People
Other: the timed 360° turn test
Turning ability is assessed by using the timed 360° turn test.




Primary Outcome Measures :
  1. The timed 360° turn test [ Time Frame: 10 seconds ]
    Turning ability is assessed by using the timed 360° turn test. In the timed 360° turn test, a piece of colored tape is placed on the floor to mark the starting position. Each subject was required to stand with arms by his/her side and feet comfortably apart and pointing to the tape. Timing was started from the word "go" and stopped when subject's shoulders were facing forward again. The time taken to complete the turn was recorded (in seconds) by a stopwatch.


Secondary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: 15 minutes ]
    Functional balance is assessed by using the Berg Balance Scale. During the test, participants are asked to perform 14 tasks frequently used in daily life activities. Each item is scored between 0 (unable to perform the task) and 4 (task is performed independently) according to the ability of the person while performing the task. The highest possible score is 56 points. A higher score indicates better balance.

  2. Trunk Impairment Scale [ Time Frame: 20 minutes ]
    Trunk performance is assessed by using the trunk impairment scale. The Trunk Impairment Scale consists of three subscales: static sitting balance, dynamic sitting balance and co-ordination. A higher score indicating a better performance.

  3. Functional Reach Test [ Time Frame: 15 seconds ]
    The Functional Reach Test assesses balance by measuring the limits while the patient reaches forwards as far as possible, having the arms in 90° flexion and without lifting the heels off the floor.

  4. Four Square Step Test [ Time Frame: 15 seconds ]
    The Four Square Step Test measures dynamic balance and clinically assesses the person's ability to step over objects forward, sideways, and backward. A square was formed by 4 canes resting flat on the floor. The participants were instructed to try and complete the sequence as fast as possible without touching the canes with both feet, making contact with the floor in each square.

  5. Timed Up and Go Test [ Time Frame: 10 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.

  6. 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).

  7. Unified Parkinson's Disease Rating Scale [ Time Frame: 15 minutes ]
    The Unified Parkinson's Disease Rating Scale is increasingly used as a gold standard reference scale and includes four components (Part I, Mentation, Behavior and Mood; Part II, Activities of Daily Living; Part III, Motor;Part IV, Complications). A lower score indicates lower disease severity.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 4,
  • were able to walk 10 m with or without aids

Exclusion Criteria:

  • visual, auditory, and orientational problems affecting study results
  • orthopedic problems affecting walking,
  • other neurologic conditions, cardiovascular, musculuskeletal, and vestibular disease

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): NCT03587168


Contacts
Contact: Faith Söke +90 506 932 81 02 fthsk_8993@hotmail.com
Contact: Arzu Güclü Gündüz arzuguclu@hotmail.com

Sponsors and Collaborators
Gazi University
Investigators
Principal Investigator: Fatih Söke Gazi University

Publications:
Responsible Party: Fatih Söke, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT03587168     History of Changes
Other Study ID Numbers: 441
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fatih Söke, Gazi University:
Parkinson's Disease
The Timed 360° Turn Test
Validity
Reliability

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases