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NCT Number: NCT06751797

Balance Confidence and Kinesiophobia in Parkinson's Disease

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).

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Location status: Recruiting

Location contact

Büşra Şirin

CONTACT

[email protected]

02124443322

Nurdan Paker, Prof

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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).

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Büşra Şirin Ahısha, MD

CONTACT

[email protected]

02124443322

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Balance Confidence, Kinesiophobia, and Associated Factors in Parkinson's Disease: A Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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