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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03827746
Other study ID # 09.2017.226
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date October 1, 2019

Study information

Verified date February 2021
Source Istanbul Kültür University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The kinesiophobia; defined as irrational fear of movement, which may occur after painful injury and reduce physical activity. It develops the idea that movement in individuals will cause re-injury and cause additional pain to existing pain. Studies have shown that this situation leads to a decrease in physical fitness, avoidance of activity, decrease in quality of life and even depression in the long term. It is known that functional problems such as balance problems and decrease in physical activity level occur in patients with Parkinson's disease. However, in the literature, there is no study investigating the presence of kinesiophobia in patients with Parkinson's disease. Therefore, the aims of our study were to 1) determine the presence / absence of kinesiophobia in patients with Parkinson's disease 2) determine the relationship between kinesiophobia and falling, balance, physical activity level in the presence of kinesiophobia.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility 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 Design


Intervention

Other:
Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy Scale
Tampa Kinesiophobia Scale: The TSK is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury. Berg-Balance Test: 14-item scale designed to measure balance of the older adult in a clinical setting. International Physical Activity Questionnaire-Short Form: 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. Falls Efficacy Scale: A 16- item self-administered questionnaire designed to assess fear of falling in mainly older population

Locations

Country Name City State
Turkey Marmara University Istanbul

Sponsors (3)

Lead Sponsor Collaborator
Istanbul Kültür University Istanbul University-Cerrahpasa, Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tampa Kinesiophobia Scale (TSK) It is a 17-item self report checklist using a 4-point Likert scale 10 minutes
Primary Berg-Balance Test 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
Primary Falls Efficacy Scale 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
Primary International Physical Activity Questionnaire - Short form 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
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