- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06751797
Balance Confidence and Kinesiophobia in Parkinson's Disease
Balance Confidence, Kinesiophobia, and Associated Factors in Parkinson's Disease: A Controlled Study
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Büşra Şirin Ahısha, MD
- Phone Number: 02124443322
- Email: bsrn080@gmail.com
Study Locations
-
-
Beylikdüzü
-
Istanbul, Beylikdüzü, Turkey, 34147
- Recruiting
- Beylikduzu State Hospital
-
Contact:
- Büşra Şirin
- Phone Number: 02124443322
- Email: bsrn080@gmail.com
-
Sub-Investigator:
- Nurdan Paker, Prof
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control group
Healthy controls
|
No intervention
|
|
Parkinson disease group
Patient with parkinson disease
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Level (Berg Balance Scale)
Time Frame: Baseline
|
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).
|
Baseline
|
|
Fear of Falling (Falls Efficacy Scale)
Time Frame: Baseline
|
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. |
Baseline
|
|
Kinesiophobia (Tampa Scale of Kinesiophobia)
Time Frame: Baseline
|
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. |
Baseline
|
|
Mental Status (MMSE)
Time Frame: Baseline
|
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).
|
Baseline
|
|
Functional status (MDS-UPDRS)
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BeylikduzuStateH13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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