Parkinson DiseaseNCT06751797
Balance Confidence and Kinesiophobia in Parkinson's Disease
An observational study of Parkinson Disease, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
31 patients aged 50-80 years diagnosed with idiopathic Parkinson's disease (Modified Hoehn-Yahr stages 1-3) and 31 healthy volunteers. At the start of the study, sociodemographic data for all participants will be recorded. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 20 Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- Adult, Older adult
Study population: Parkinson disease and healthy controls
Who may be able to join
- Diagnosis of Idiopathic Parkinson's Disease by a neurology specialist.
- Modified Hoehn-Yahr Staging Scale classification between stages 1-3.
- Mini-Mental State Examination (MMSE) score of 24 or higher.
- Age between 50-80 years.
- Volunteered to participate in the study.
Who cannot join
- Use of medications, apart from routine Parkinson's disease treatments, that could affect balance or muscle strength.
- Presence of neurological or musculoskeletal conditions other than Parkinson's disease.
- Refusal to participate in the study.
- Presence of psychiatric disorders.
- Presence of cognitive impairments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
Büşra Şirin, 02124443322, bsrn080@gmail.com
Nurdan Paker, Prof
About this study
Official title: Balance Confidence, Kinesiophobia, and Associated Factors in Parkinson's Disease: A Controlled Study
31 patients aged 50-80 years diagnosed with idiopathic Parkinson's disease (Modified Hoehn-Yahr stages 1-3) and 31 healthy volunteers. At the start of the study, sociodemographic data for all participants will be recorded. To assess the mental and functional status of Parkinson's disease patients, the Mini-Mental State Examination (MMSE) and the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used. Balance confidence levels will be assessed using the Activities-specific Balance Confidence Scale-6 (ABC-6), overall balance using the Berg Balance Scale (BBS), fear of falling using the Falls Efficacy Scale (FES), and kinesiophobia levels using the Tampa Scale of Kinesiophobia (TSK).
- Conditions
- Parkinson Disease
- Being tested
- No intervention
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Parkinson disease group | Patient with parkinson disease Receives: Other: No intervention | |
| Control group | Healthy controls Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Confidence (ABC-6 Scale)
Evaluated using the Activities-specific Balance Confidence Scale-6 (ABC-6), which measures participants' confidence in maintaining balance during various daily activities. Lower scores indicate reduced balance confidence, a common issue in Parkinson's disease.
In the ABC-6 scale, the minimum score is 0% (no confidence), the maximum score is 100% (full confidence), and the total score is calculated as the average of the percentages given for all activities.
Measured: Baseline
Secondary outcomes (5)
Balance Level (Berg Balance Scale)
Assessed using the Berg Balance Scale (BBS) to quantify participants' overall balance performance through functional balance tasks. Lower scores reflect greater balance impairment. In the Berg Balance Scale (BBS), the minimum score is 0 (indicating poor balance), and the maximum score is 56 (indicating excellent balance). The total score is the sum of the individual scores from 14 items, each rated on a 5-point scale (0-4).
Measured: Baseline
Fear of Falling (Falls Efficacy Scale)
Measured using the Falls Efficacy Scale (FES), which evaluates fear of falling during specific activities. Higher scores indicate a greater fear of falling, often linked to reduced mobility and participation.
In the Falls Efficacy Scale (FES), the minimum score is 10 (indicating no fear of falling), and the maximum score is 100 (indicating extreme fear of falling). The score is calculated by summing the ratings for 10 items, each scored on a 1-10 scale.
Measured: Baseline
Kinesiophobia (Tampa Scale of Kinesiophobia)
Assessed with the Tampa Scale of Kinesiophobia (TSK) to measure fear of movement or re-injury. Higher scores indicate greater kinesiophobia, potentially limiting physical activity in Parkinson's patients.
In the Tampa Scale of Kinesiophobia (TSK), the minimum score is 17 (indicating low kinesiophobia), and the maximum score is 68 (indicating high kinesiophobia). The total score is obtained by summing the ratings for 17 items, each scored on a 1-4 scale.
Measured: Baseline
Mental Status (MMSE)
The Mini-Mental State Examination (MMSE) evaluates cognitive function, including orientation, memory, attention, language, and visuospatial skills, with scores ranging from 0 (severe cognitive impairment) to 30 (normal cognitive function).
Measured: Baseline
Functional status (MDS-UPDRS)
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assesses functional status and disease severity in Parkinson's disease, encompassing non-motor and motor experiences of daily living, motor examination, and motor complications. The total score ranges from 0 (no symptoms) to 260 (severe symptoms), with higher scores indicating greater disease severity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start10 Dec 2024
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Jan 2025 (estimated)
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-control
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751797
- Sponsor's protocol ID
- BeylikduzuStateH13
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Confidence, Kinesiophobia, and Associated Factors in Parkinson's Disease: A Controlled Study
- ClinicalTrials.gov ID
- NCT06751797
- Acronym / sponsor ID
- BeylikduzuStateH13
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 30 Dec 2024 (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.
31 patients aged 50-80 years diagnosed with idiopathic Parkinson's disease (Modified Hoehn-Yahr stages 1-3) and 31 healthy volunteers. At the start of the study, sociodemographic data for all participants will be recorded. To assess the mental and functional status of Parkinson's disease patients, the Mini-Mental State Examination (MMSE) and the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used. Balance confidence levels will be assessed using the Activities-specific Balance Confidence Scale-6 (ABC-6), overall balance using the Berg Balance Scale (BBS), fear of falling using the Falls Efficacy Scale (FES), and kinesiophobia levels using the Tampa Scale of Kinesiophobia (TSK).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson disease group | – | Other: No interventionPatient with parkinson disease |
| Control group | – | Other: No interventionHealthy controls |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Parkinson disease and healthy controls
Key inclusion criteria (5 listed)
- Diagnosis of Idiopathic Parkinson's Disease by a neurology specialist.
- Modified Hoehn-Yahr Staging Scale classification between stages 1-3.
- Mini-Mental State Examination (MMSE) score of 24 or higher.
- Age between 50-80 years.
- Volunteered to participate in the study.
Key exclusion criteria (5 listed)
- Use of medications, apart from routine Parkinson's disease treatments, that could affect balance or muscle strength.
- Presence of neurological or musculoskeletal conditions other than Parkinson's disease.
- Refusal to participate in the study.
- Presence of psychiatric disorders.
- Presence of cognitive impairments.
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 |
|---|---|---|
| No interventionNo intervention | Other | Control group, Parkinson disease group |
Primary outcome
Balance Confidence (ABC-6 Scale)
Time frame: Baseline
Evaluated using the Activities-specific Balance Confidence Scale-6 (ABC-6), which measures participants' confidence in maintaining balance during various daily activities. Lower scores indicate reduced balance confidence, a common issue in Parkinson's disease. In the ABC-6 scale, the minimum score is 0% (no confidence), the maximum score is 100% (full confidence), and the total score is calculated as the average of the percentages given for all activities.
5 secondary outcomes
Balance Level (Berg Balance Scale)
Time frame: Baseline
Fear of Falling (Falls Efficacy Scale)
Time frame: Baseline
Kinesiophobia (Tampa Scale of Kinesiophobia)
Time frame: Baseline
Mental Status (MMSE)
Time frame: Baseline
Functional status (MDS-UPDRS)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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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.
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, run by Beylikduzu State Hospital 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Büşra Şirin Ahısha, MD (02124443322, bsrn080@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Confidence (ABC-6 Scale) (time frame: Baseline). 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 30 Dec 2024.