Multiple SclerosisNCT06167447
Evaluation of the Presence and Effects of Kinesiophobia in Multiple Sclerosis
An observational study of Multiple Sclerosis and Kinesiophobia, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the presence of kinesiophobia in multiple sclerosis and to investigate the effect of kinesiophobia on physical activity, functional status, quality of life and depression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Kinesiophobia
- What is being tested?
- questionnaire and examination
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Jun 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 90 people, 45 patients and 45 healthy controls, who applied to the Gazi University Medical School PM\&R and Neurology multiple sclerosis outpatient clinic between the ages of 18-65, were included in the study.
Who may be able to join
- Having a definitive diagnosis of MS according to the 2017 Revised McDonald Diagnostic Criteria
- Expanded Disability Status Scale (EDSS) score between 0-6.5
- Be between the ages of 18-65
- Volunteering to participate in the study
Who cannot join
- Having orthopedic, psychiatric and other chronic diseases other than MS that may affect physical and cognitive status
- Expanded Disability Status Scale (EDSS) score >6.5
- Being in the MS attack period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of The Existence Of Kinesiophobia In Patients With Multiple Sclerosis; Effect Of Kinesiophobia On Physical Activity,Functional Status, Quality Of Life and Depression
The aim of this study was to evaluate the presence of kinesiophobia in multiple sclerosis and to investigate the effect of kinesiophobia on physical activity, functional status, quality of life and depression.
Read the detailed description
90 people, including 45 patients and 45 healthy control groups, were included in the study. Demographic data of all participants were recorded. Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), Quality of Life Scale Short Form-36 (SF-36), International Physical Activity Questionnaire Short Form (IPAQ-SF), Functional Ambulation Classification (FAS), in addition to Multiple Sclerosis group, Functional Independence Measure (FIM), Expanded Disability Status Scale (EDSS) were implemented.
- Conditions
- Multiple Sclerosis, Kinesiophobia
- Being tested
- questionnaire and examination
- Keywords
- Multiple sclerosis, kinesiophobia, fear of movement
- Medical subject headings
- Multiple Sclerosis, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire and examinationOther
Demographic data of all participants, height, weight, body mass index, occupation, marriage status, education level, comorbidities, medications used, duration of illness and subtype will be recorded by the researcher. Questionnaires to be filled by patients. On the same day, the musculoskeletal system and neurological examination of the participants will be evaluated by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| multiple sclerosis group | Demographic data of all participants were recorded. Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), Quality of Life Scale Short Form-36 (SF-36), International Physical Activity Questionnaire Short Form (IPAQ-SF), Functional Ambulation Classification (FAS), Functional Independence Measure (FIM), Expanded Disability Status Scale (EDSS) were implemented. Receives: Other: questionnaire and examination | |
| control group | Demographic data of all participants were recorded. Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), Quality of Life Scale Short Form-36 (SF-36), International Physical Activity Questionnaire Short Form (IPAQ-SF), Functional Ambulation Classification (FAS) Receives: Other: questionnaire and examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Scale of Kinesiophobia
Tampa Scale of Kinesiophobia is a checklist of 17 questions developed to measure the fear of movement and re-injury. It is used in many situations such as Acute and chronic pain, Fibromyalgia Syndrome (FMS), musculoskeletal system related injuries, etc. Items in the scale are scored according to a 4-point Likert scoring. A total score of 37 points and above indicates a high level of kinesiophobia.
Measured: through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jan 2021
- Primary completion1 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Nur Kilinc, Gazi University
- Investigators
- Bilge Nur Kilinc, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167447
- Sponsor's protocol ID
- BNKilinc
- Status last verified
- Dec 2023
- First submitted
- 26 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dobson R, Giovannoni G. Multiple sclerosis - a review. Eur J Neurol. 2019 Jan;26(1):27-40. doi: 10.1111/ene.13819. Epub 2018 Nov 18.
PubMed 30300457Zalc B. One hundred and fifty years ago Charcot reported multiple sclerosis as a new neurological disease. Brain. 2018 Dec 1;141(12):3482-3488. doi: 10.1093/brain/awy287. No abstract available.
PubMed 30462211Walton C, King R, Rechtman L, Kaye W, Leray E, Marrie RA, Robertson N, La Rocca N, Uitdehaag B, van der Mei I, Wallin M, Helme A, Angood Napier C, Rijke N, Baneke P. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler. 2020 Dec;26(14):1816-1821. doi: 10.1177/1352458520970841. Epub 2020 Nov 11.
PubMed 33174475Kesselring J, Beer S. Symptomatic therapy and neurorehabilitation in multiple sclerosis. Lancet Neurol. 2005 Oct;4(10):643-52. doi: 10.1016/S1474-4422(05)70193-9.
PubMed 16168933
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Existence Of Kinesiophobia In Patients With Multiple Sclerosis; Effect Of Kinesiophobia On Physical Activity,Functional Status, Quality Of Life and Depression
- ClinicalTrials.gov ID
- NCT06167447
- Acronym / sponsor ID
- BNKilinc
- Conditions
- Multiple Sclerosis, Kinesiophobia
- Keywords
- Multiple sclerosis, kinesiophobia, fear of movement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 12 Dec 2023 (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 aim of this study was to evaluate the presence of kinesiophobia in multiple sclerosis and to investigate the effect of kinesiophobia on physical activity, functional status, quality of life and depression.
Detailed description
90 people, including 45 patients and 45 healthy control groups, were included in the study. Demographic data of all participants were recorded. Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), Quality of Life Scale Short Form-36 (SF-36), International Physical Activity Questionnaire Short Form (IPAQ-SF), Functional Ambulation Classification (FAS), in addition to Multiple Sclerosis group, Functional Independence Measure (FIM), Expanded Disability Status Scale (EDSS) were implemented.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiple sclerosis group | – | Other: questionnaire and examinationDemographic data of all participants were recorded. Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), Quality of Life Scale Short Form-36 (SF-36), International Physical Activity Questionnaire Short Form (IPAQ-SF), Functional Ambulation Classification (FAS), Functional Independence Measure (FIM), Expanded Disability Status Scale (EDSS) were implemented. |
| control group | – | Other: questionnaire and examinationDemographic data of all participants were recorded. Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), Quality of Life Scale Short Form-36 (SF-36), International Physical Activity Questionnaire Short Form (IPAQ-SF), Functional Ambulation Classification (FAS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 90 people, 45 patients and 45 healthy controls, who applied to the Gazi University Medical School PM\&R and Neurology multiple sclerosis outpatient clinic between the ages of 18-65, were included in the study.
Key inclusion criteria (4 listed)
- Having a definitive diagnosis of MS according to the 2017 Revised McDonald Diagnostic Criteria
- Expanded Disability Status Scale (EDSS) score between 0-6.5
- Be between the ages of 18-65
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- Having orthopedic, psychiatric and other chronic diseases other than MS that may affect physical and cognitive status
- Expanded Disability Status Scale (EDSS) score >6.5
- Being in the MS attack period
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 |
|---|---|---|
| questionnaire and examinationDemographic data of all participants, height, weight, body mass index, occupation, marriage status, education level, comorbidities, medications used, duration of illness and subtype will be recorded by the researcher. Questionnaires to be filled by patients. On the same day, the musculoskeletal system and neurological examination of the participants will be evaluated by the researcher. | Other | control group, multiple sclerosis group |
Primary outcome
Tampa Scale of Kinesiophobia
Time frame: through study completion, an average of 6 months.
Tampa Scale of Kinesiophobia is a checklist of 17 questions developed to measure the fear of movement and re-injury. It is used in many situations such as Acute and chronic pain, Fibromyalgia Syndrome (FMS), musculoskeletal system related injuries, etc. Items in the scale are scored according to a 4-point Likert scoring. A total score of 37 points and above indicates a high level of kinesiophobia.
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 12 Dec 2023.
- Background: PubMed 30300457Dobson R, Giovannoni G. Multiple sclerosis - a review. Eur J Neurol. 2019 Jan;26(1):27-40. doi: 10.1111/ene.13819. Epub 2018 Nov 18.
- Background: PubMed 30462211Zalc B. One hundred and fifty years ago Charcot reported multiple sclerosis as a new neurological disease. Brain. 2018 Dec 1;141(12):3482-3488. doi: 10.1093/brain/awy287. No abstract available.
- Background: PubMed 33174475Walton C, King R, Rechtman L, Kaye W, Leray E, Marrie RA, Robertson N, La Rocca N, Uitdehaag B, van der Mei I, Wallin M, Helme A, Angood Napier C, Rijke N, Baneke P. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler. 2020 Dec;26(14):1816-1821. doi: 10.1177/1352458520970841. Epub 2020 Nov 11.
- Background: PubMed 16168933Kesselring J, Beer S. Symptomatic therapy and neurorehabilitation in multiple sclerosis. Lancet Neurol. 2005 Oct;4(10):643-52. doi: 10.1016/S1474-4422(05)70193-9.
- Individual participant dataSharing planned: Undecided
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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.
Bilge Nur Kilinc study director
Gazi University
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 Multiple Sclerosis and Kinesiophobia, run by Gazi 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 4 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 12 Dec 2023. 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 Scale of Kinesiophobia (time frame: through study completion, an average of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06167447, which also lists 4 linked publications.
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 12 Dec 2023.