Balance Confidence and Kinesiophobia in Parkinson's Disease

NCT06751797 | Recruiting

• 1 other identifier: BeylikduzuStateH13
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Balance Level (Berg Balance Scale)

  Baseline

• Fear of Falling (Falls Efficacy Scale)

  Baseline

• Kinesiophobia (Tampa Scale of Kinesiophobia)

  Baseline

• Mental Status (MMSE)

  Baseline

• Functional status (MDS-UPDRS)

  Baseline

Study Arms (2)

Parkinson disease group

Patient with parkinson disease

Other: No intervention

Control group

Healthy controls

Other: No intervention

Interventions

No intervention OTHER

No intervention

Control group; Parkinson disease group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson disease and healthy controls

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beylikduzu State Hospital: lead

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Büşra Şirin Ahısha, MD

CONTACT

02124443322; bsrn080@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 30, 2024
• Study Start: December 10, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)