NCT03587168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

July 20, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

21 days

First QC Date

July 3, 2018

Last Update Submit

October 23, 2018

Conditions

Parkinson Disease

Keywords

Parkinson's DiseaseThe Timed 360° Turn TestValidityReliability

Outcome Measures

Primary Outcomes (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.

    10 seconds

Secondary Outcomes (7)

  • Berg Balance Scale

    15 minutes

  • Trunk Impairment Scale

    20 minutes

  • Functional Reach Test

    15 seconds

  • Four Square Step Test

    15 seconds

  • Timed Up and Go Test

    10 seconds

  • +2 more secondary outcomes

Study Arms (2)

Patients with Parkinson's Disease

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

Other: the timed 360° turn testOther: Berg Balance ScaleOther: Four Square Step TestOther: Functional Reach TestOther: Trunk Impairment ScaleOther: Timed Up and Go TestOther: Hoehn and Yahr ScaleOther: Unified Parkinson's Disease Rating Scale

Healthy Controls

Healthy People

Other: the timed 360° turn test

Interventions

the timed 360° turn testOTHER

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

Healthy ControlsPatients with Parkinson's Disease
Berg Balance ScaleOTHER

Functional balance is assessed by using the Berg Balance Scale.

Patients with Parkinson's Disease
Four Square Step TestOTHER

The Four Square Step Test measures dynamic balance.

Patients with Parkinson's Disease
Functional Reach TestOTHER

The Functional Reach Test assesses limits of stability.

Patients with Parkinson's Disease
Trunk Impairment ScaleOTHER

Trunk performance is assessed by using the trunk impairment scale.

Patients with Parkinson's Disease
Timed Up and Go TestOTHER

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

Patients with Parkinson's Disease
Hoehn and Yahr ScaleOTHER

Disease stage is assessed by the Hoehn and Yahr Scale.

Patients with Parkinson's Disease
Unified Parkinson's Disease Rating ScaleOTHER

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

Patients with Parkinson's Disease

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Söke

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 8996460BACKGROUND

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

    PMID: 18608364BACKGROUND

  • 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.

    PMID: 24880056BACKGROUND

  • 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.

    PMID: 16338159BACKGROUND

  • 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.

    PMID: 26694578BACKGROUND

  • 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.

    PMID: 1736161BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Fatih Söke

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 16, 2018

Study Start

July 20, 2018

Primary Completion

August 10, 2018

Study Completion

August 20, 2018

Last Updated

October 24, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)