- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03827746
The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey
- Marmara University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The population of the study consisted of patients with Parkinson's disease who were in 1-3 stages according to Hoehn-Yahr Scale.
The sample consisted of 60 patients who applied to Istanbul University Cerrahpaşa Medical Faculty Neurology Department Movement Disorders Unit, complied with the inclusion criteria, read the information form and signed an informed consent form.
Description
Inclusion Criteria:
- Being diagnosed with Parkinson's disease according to the criteria of United Kingdom Brain Bank and diagnosed as Parkinson's disease by neurologist
- According to Hoehn-Yahr scale 1-3
- Mini-Mental Test score 24 and above
Exclusion Criteria:
- Another disease that will prevent walking
- Visual impairment and vestibular dysfunction
- Cognitive impairment
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Kinesiophobia Scale (TSK)
Time Frame: 10 minutes
|
It is a 17-item self report checklist using a 4-point Likert scale
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10 minutes
|
|
Berg-Balance Test
Time Frame: 15-20 minutes
|
14-item scale designed to measure balance of the older adult in a clinical setting.
Scoring: A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function.
Total Score = 56 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk
|
15-20 minutes
|
|
Falls Efficacy Scale
Time Frame: 5-7 minutes
|
It is a 10 item scale where each item is rated on a scale of 1-10.
A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence.
Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
|
5-7 minutes
|
|
International Physical Activity Questionnaire - Short form
Time Frame: 5-10 minutes
|
This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days) 1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorousintensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week OR • 7 or more days of any combination of walki |
5-10 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2017.226
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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