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Parkinson DiseaseNCT03587168

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

An observational study of Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
the timed 360° turn test, Berg Balance Scale and Four Square Step Test
How many people
86 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jul 2018to 20 Aug 2018
How long will I take part?
1 Week
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Fatih Söke

    Ankara, 06560

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
the timed 360° turn test, Berg Balance Scale, Four Square Step Test, Functional Reach Test, Trunk Impairment Scale
Keywords
Parkinson's Disease, The Timed 360° Turn Test, Validity, Reliability
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • the timed 360° turn testOther

    Turning ability is assessed by using the timed 360° turn test.

  • Berg Balance ScaleOther

    Functional balance is assessed by using the Berg Balance Scale.

  • Four Square Step TestOther

    The Four Square Step Test measures dynamic balance.

  • Functional Reach TestOther

    The Functional Reach Test assesses limits of stability.

  • Trunk Impairment ScaleOther

    Trunk performance is assessed by using the trunk impairment scale.

  • Timed Up and Go TestOther

    Functional mobility is assessed by using the timed up and go test.

  • Hoehn and Yahr ScaleOther

    Disease stage is assessed by the Hoehn and Yahr Scale.

  • Unified Parkinson's Disease Rating ScaleOther

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

Study groups in NCT03587168
Study groupRoleWhat they receive
Patients with Parkinson's DiseasePatients with Parkinson's Disease Parkinson's Disease (Hoehn and Yahr stage 1-4)
Receives: 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
Healthy ControlsHealthy People
Receives: Other: the timed 360° turn test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The timed 360° turn test

    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.

    Measured: 10 seconds

Secondary outcomes (7)

  1. Berg Balance Scale

    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.

    Measured: 15 minutes

  2. Trunk Impairment Scale

    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.

    Measured: 20 minutes

  3. Functional Reach Test

    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.

    Measured: 15 seconds

  4. Four Square Step Test

    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.

    Measured: 15 seconds

  5. 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.

    Measured: 10 seconds

  6. 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).

    Measured: 1 minutes

  7. Unified Parkinson's Disease Rating Scale

    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.

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2018
  2. Study start20 Jul 2018
  3. Primary completion10 Aug 2018
  4. Study completion20 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
86 participants (actual)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT03587168
Sponsor's protocol ID
441
Status last verified
Oct 2018
First submitted
3 Jul 2018
Last updated
24 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schenkman M, Cutson TM, Kuchibhatla M, Chandler J, Pieper C. Reliability of impairment and physical performance measures for persons with Parkinson's disease. Phys Ther. 1997 Jan;77(1):19-27. doi: 10.1093/ptj/77.1.19.

    PubMed 8996460

  • Stack E, Ashburn A. Dysfunctional turning in Parkinson's disease. Disabil Rehabil. 2008;30(16):1222-9. doi: 10.1080/09638280701829938.

    PubMed 18608364

  • Kluger BM, Brown RP, Aerts S, Schenkman M. Determinants of objectively measured physical functional performance in early to mid-stage Parkinson disease. PM R. 2014 Nov;6(11):992-8. doi: 10.1016/j.pmrj.2014.05.013. Epub 2014 May 28.

    PubMed 24880056

  • Stack EL, Ashburn AM, Jupp KE. Strategies used by people with Parkinson's disease who report difficulty turning. Parkinsonism Relat Disord. 2006 Mar;12(2):87-92. doi: 10.1016/j.parkreldis.2005.08.008. Epub 2005 Dec 9.

    PubMed 16338159

  • Shiu CH, Ng SS, Kwong PW, Liu TW, Tam EW, Fong SS. Timed 360 degrees Turn Test for Assessing People With Chronic Stroke. Arch Phys Med Rehabil. 2016 Apr;97(4):536-544. doi: 10.1016/j.apmr.2015.11.010. Epub 2015 Dec 13.

    PubMed 26694578

  • Giladi N, McMahon D, Przedborski S, Flaster E, Guillory S, Kostic V, Fahn S. Motor blocks in Parkinson's disease. Neurology. 1992 Feb;42(2):333-9. doi: 10.1212/wnl.42.2.333.

    PubMed 1736161

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The timed 360° turn test (time frame: 10 seconds). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03587168, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.

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