- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03587168
The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's Disease
October 23, 2018 updated by: Fatih Söke, Gazi University
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
86
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06560
- Fatih Söke
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders 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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with Parkinson's Disease
Patients with Parkinson's Disease Parkinson's Disease (Hoehn and Yahr stage 1-4)
|
Turning ability is assessed by using the timed 360° turn test.
Functional balance is assessed by using the Berg Balance Scale.
The Four Square Step Test measures dynamic balance.
The Functional Reach Test assesses limits of stability.
Trunk performance is assessed by using the trunk impairment scale.
Functional mobility is assessed by using the timed up and go test.
Disease stage is assessed by the Hoehn and Yahr Scale.
The Unified Parkinson's Disease Rating Scale assesses disease severity.
|
|
Healthy Controls
Healthy People
|
Turning ability is assessed by using the timed 360° turn test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
15 minutes
|
|
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.
|
20 minutes
|
|
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.
|
15 seconds
|
|
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.
|
15 seconds
|
|
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.
|
10 seconds
|
|
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).
|
1 minutes
|
|
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.
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fatih Söke, Gazi University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Stack E, Ashburn A. Dysfunctional turning in Parkinson's disease. Disabil Rehabil. 2008;30(16):1222-9. doi: 10.1080/09638280701829938.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2018
Primary Completion (Actual)
August 10, 2018
Study Completion (Actual)
August 20, 2018
Study Registration Dates
First Submitted
July 3, 2018
First Submitted That Met QC Criteria
July 13, 2018
First Posted (Actual)
July 16, 2018
Study Record Updates
Last Update Posted (Actual)
October 24, 2018
Last Update Submitted That Met QC Criteria
October 23, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
Bezmialem Vakif UniversityRecruitingParkinson Disease | Parkinson | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseTurkey (Türkiye)
-
CND Life SciencesDigestive Disease Associates of CTRecruitingParkinson Disease | Parkinson | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
Neuron23 Inc.Roche Diagnostic Ltd.; Qiagen Manchester LimitedRecruitingParkinson Disease | Parkinson | Idiopathic Parkinson Disease | Parkinson Disease, Idiopathic | Early Parkinson Disease (Early PD)United States, Spain, Israel, Poland, Italy, United Kingdom
-
San Francisco Neurology and Sleep CenterRecruitingPARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
Haukeland University HospitalUniversity of Bergen; SPARK NSRecruitingParkinson Disease (PD) | Parkinson s DiseaseNorway
-
Bezmialem Vakif UniversityIstanbul University - CerrahpasaNot yet recruitingParkinson Disease | PARKINSON DISEASE (Disorder) | Parkinson Disease (PD), Postural Balance
-
CND Life SciencesOregon Health and Science UniversityRecruitingParkinson Disease | Parkinson | Parkinson's Disease and Parkinsonism | PARKINSON DISEASE (Disorder)United States
-
Università degli Studi dell'InsubriaUniversidade Nova de Lisboa; Associazione Parkinson Insubria (AsPI), Section... and other collaboratorsRecruitingParkinson Disease | Parkinson | Parkinson Disease, Idiopathic | PARKINSON DISEASE (Disorder)Italy
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
Duke UniversityMedical University of South Carolina; Massachusetts General Hospital; Mayo Clinic and other collaboratorsNot yet recruitingGut Microbiota | Gut Microbiome | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Prodromal Parkinsons DiseaseUnited States
Clinical Trials on the timed 360° turn test
-
Kahramanmaras Sutcu Imam UniversityCompletedCerebral Palsy | Gait, Spastic | Gait Disorders in Children | Diplegic Cerebral Palsy | Hemiplegic Cerebral PalsyTurkey
-
Gazi UniversityCompletedMultiple SclerosisTurkey
-
Gazi UniversityCompletedMultiple Sclerosis, Relapsing-RemittingTurkey
-
Clalit Health ServicesUnknownElderly | Falls | Postural BalanceIsrael
-
Uskudar State HospitalRecruitingMultiple SclerosisTurkey
-
Centre d'Investigation Clinique et Technologique...Completed
-
Istinye UniversityCompletedStroke | Tele-assessment | The Timed Up & Go Test | 30second Chair-Stand TestTurkey
-
University of HaifaCompletedHealthy Aging | Gender | Swallowing Disorder
-
Istanbul University - Cerrahpasa (IUC)CompletedMultiple Sclerosis | Gait Disorders, Neurologic | Upper Extremity ProblemTurkey
-
Afyonkarahisar Health Sciences UniversityRecruiting