- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04267341
Effect of Dual Task on Upper and Lower Extremity Skills in Parkinson's Disease
December 1, 2020 updated by: Elvan ÖZCAN GÜLŞEN, Hacettepe University
Examining The Change of Upper and Lower Extremity Skills With The Effect of Dual Task in Parkinson's Disease Patients
The aim of the study is to investigate the change of lower and upper extremity skills with dual task in Parkinson's disease patients and to determine the differences between Parkinson's disease patients with different stages of disease and the healthy controls regarding the change of lower and upper extremity skills with dual task.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
45
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
-
-
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Ankara, Turkey, 06100
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation
-
-
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
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with Parkinson's Disease who apply to the Hacettepe University, Faculty of Physiotherapy and Rehabilitation, Department of Neurological Rehabilitation will be invited to this study.
Description
Inclusion Criteria:
- Modified Hoehn & Yahr (H&Y) stages 1 to 3
- at least 40 years of age
- 21 or more MoCA score.
Exclusion Criteria:
- other neurologic disorder
- any orthopedic problem that could prevent to participate in the study
- severe dyskinesia or tremor
- visual or speech problems
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: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Mild Stage Parkinson's Disease Patients
Modified Hoehn and Yahr stage 1-2
|
It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again
10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance
Purdue Pegboard test evaluates the fine manuel dexterity
|
|
Moderate Stage Parkinson's Disease Patients
Modified Hoehn and Yahr stage 2.5-3
|
It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again
10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance
Purdue Pegboard test evaluates the fine manuel dexterity
|
|
Healthy Control
Healthy People
|
It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again
10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance
Purdue Pegboard test evaluates the fine manuel dexterity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go Test
Time Frame: 10-15 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.
|
10-15 seconds
|
|
10 Meter Walk Test
Time Frame: 10-15 seconds
|
10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance.
|
10-15 seconds
|
|
Purdue Pegboard Test
Time Frame: 3-5 minutes
|
Purdue Pegboard Test assesses the speed and motor dexterity of each hand and the manual dexterity using both hands at the same time.
The PPT consists of a board with two columns with 25 holes each and a specific number of pins, washers and collars placed in four containers across the top of the board.
|
3-5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Hoehn and Yahr Scale
Time Frame: 1 minute
|
Modified Hoehn and Yahr Scale allocates stages from 0 to 5 to indicate the relative level of disability and stage of disease.
Higher level indicates worse physical condition.
|
1 minute
|
|
Montreal Cognitive Assessment (MoCA)
Time Frame: 10-15 minutes
|
Montreal Cognitive Assessment (MoCA) will be used in order to evaluate cognition.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.It' score ranged from 0 to 30 and higher points indicates better cognitive outcomes.
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10-15 minutes
|
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Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)
Time Frame: 1-2 minutes
|
The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients.
It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all).
The total score ranges from 0 to 32.
Higher scores indicates poorer quality of life.
|
1-2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2020
Primary Completion (Actual)
March 15, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
February 11, 2020
First Submitted That Met QC Criteria
February 11, 2020
First Posted (Actual)
February 12, 2020
Study Record Updates
Last Update Posted (Actual)
December 3, 2020
Last Update Submitted That Met QC Criteria
December 1, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/24-01
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.
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