Health TrialsbyHealthPanel

Balance Confidence and Kinesiophobia in Parkinson's Disease

ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorBeylikduzu State Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Parkinson disease and healthy controls

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Parkinson disease group1 intervention
Group B: Control group1 intervention

Trial outcomes

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.

Time frame
Baseline

Secondary outcomes

1

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).

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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).

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beylikduzu State Hospital

Lead sponsor

Source ClinicalTrials.gov
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