Balance Confidence and Kinesiophobia in Parkinson's Disease

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).

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 62

Contacts and Locations

• Study Contact: Name: Büşra Şirin Ahısha, MD; Phone Number: 02124443322; Email: bsrn080@gmail.com

Study Locations

• Turkey
  • Beylikdüzü
    • Istanbul, Beylikdüzü, Turkey, 34147
      • Recruiting
      • Beylikdüzü 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: N/A

• Sampling Method: Non-Probability Sample

Study Population

Parkinson disease and healthy controls

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Healthy controls	Other: No intervention; No intervention
Parkinson disease group; Patient with parkinson disease	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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).	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.	Baseline

Collaborators and Investigators

• Sponsor: Beylikduzu State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): January 20, 2025
• Study Completion (Estimated): January 20, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Phobic Disorders; Anxiety Disorders; Kinesiophobia; Parkinson Disease
• Other Study ID Numbers: BeylikduzuStateH13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No