Parkinson DiseaseNCT03827746
The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients
An observational study of Parkinson Disease and Kinesiophobia, run by Istanbul Kültür University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease, Kinesiophobia, Physical Activity
- What is being tested?
- Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy Scale
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Another disease that will prevent walking
- Visual impairment and vestibular dysfunction
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Parkinson Disease, Kinesiophobia, Physical Activity, Balance, Falling
- Being tested
- Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy Scale
- Keywords
- Parkinson's Disease, Kinesiophobia, Physical Activity, Balance, Falling
- Medical subject headings
- Parkinson Disease, Kinesiophobia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy ScaleOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Kinesiophobia Scale (TSK)
It is a 17-item self report checklist using a 4-point Likert scale
Measured: 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
Measured: 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.
Measured: 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)
- 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
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Apr 2018
- Primary completion1 Apr 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kültür University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University, Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Gamze Ertürk, Istanbul Kültür University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827746
- Sponsor's protocol ID
- 09.2017.226
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2019
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT03827746
- Acronym / sponsor ID
- 09.2017.226
- Conditions
- Parkinson Disease, Kinesiophobia, Physical Activity, Balance, Falling
- Keywords
- Parkinson's Disease, Kinesiophobia, Physical Activity, Balance, Falling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Kültür UniversityUniversity, hospital or other
- Collaborators
- Marmara University, Istanbul University - Cerrahpasa
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Another disease that will prevent walking
- Visual impairment and vestibular dysfunction
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy ScaleTampa 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 | Other | – |
Primary outcome
Tampa Kinesiophobia Scale (TSK)
Time frame: 10 minutes
It is a 17-item self report checklist using a 4-point Likert scale
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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Kinesiophobia, run by Istanbul Kültür University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Kinesiophobia Scale (TSK) (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.