NCT03827746

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

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

Study Start

First participant enrolled

April 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 31, 2019

Last Update Submit

February 16, 2021

Conditions

Keywords

Parkinson's Disease, Kinesiophobia, Physical Activity, Balance, Falling

Outcome Measures

Primary Outcomes (4)

  • Tampa Kinesiophobia Scale (TSK)

    It is a 17-item self report checklist using a 4-point Likert scale

    10 minutes

  • 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

  • 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

  • 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

Interventions

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

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Another disease that will prevent walking
  • Visual impairment and vestibular dysfunction
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson DiseaseKinesiophobiaMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPhobic DisordersAnxiety DisordersMental DisordersBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 1, 2019

Study Start

April 1, 2018

Primary Completion

April 1, 2019

Study Completion

October 1, 2019

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations