- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07488351
"Self-Compassion and Self-Efficacy in Parkinson's Disease: Associations With Symptoms, Function, and Quality of Life"
"Associations of Self-Compassion and Self-Efficacy With Symptom Severity, Functional Status, and Quality of Life in Individuals With Parkinson's Disease: A Cross-Sectional Study"
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinically diagnosed Parkinson's disease
Hoehn and Yahr stage 1-3
Age between 40 and 85 years
Sufficient cognitive function to communicate (Mini-Mental State Examination [MMSE] score ≥ 24)
Patients attending the Movement Disorders Outpatient Clinic of the Neurology Department
Willingness to participate and provide informed consent
Exclusion Criteria:
- Presence of psychiatric disorders (e.g., major depression, psychotic disorders)
Diagnosis of advanced dementia
Presence of uncontrolled systemic chronic diseases (e.g., diabetes mellitus, hypertension) or severe cardiovascular or respiratory conditions
Presence of additional orthopedic or neurological conditions that may affect test performance
Severe visual or hearing impairments that could interfere with assessments
Inability to cooperate adequately with the physiotherapist during assessments
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Compassion Scale (SCS) Total Score
Time Frame: Baseline (at the time of questionnaire completion)
|
Self-compassion will be measured using the Self-Compassion Scale (SCS), a validated self-report instrument assessing multiple dimensions of self-compassion.
The total score will be calculated, with higher scores indicating greater self-compassion.
|
Baseline (at the time of questionnaire completion)
|
|
Self-Efficacy for Managing Chronic Disease 6-Item Scale Total Score
Time Frame: Baseline (at the time of questionnaire completion)
|
Self-efficacy will be measured using the Self-Efficacy for Managing Chronic Disease 6-Item Scale, a validated self-report measure.
The total score will be calculated, with higher scores indicating greater perceived self-efficacy.
|
Baseline (at the time of questionnaire completion)
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Time Frame: Baseline (at the time of questionnaire completion)
|
Symptom severity will be measured using the Unified Parkinson's Disease Rating Scale (UPDRS), a validated clinician-rated instrument assessing motor and non-motor symptoms.
Higher total scores indicate greater disease severity.
|
Baseline (at the time of questionnaire completion)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go (TUG) Test Completion Time in Seconds
Time Frame: Baseline (at the time of questionnaire completion)
|
Functional mobility will be measured using the Timed Up and Go (TUG) test.
The time required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds.
Longer times indicate poorer functional mobility.
|
Baseline (at the time of questionnaire completion)
|
|
Six-Minute Walk Test (6MWT) Distance in Meters
Time Frame: Baseline (at the time of questionnaire completion)
|
Functional exercise capacity will be measured using the Six-Minute Walk Test (6MWT).
The total distance walked in six minutes will be recorded in meters.
Greater distances indicate better functional capacity.
|
Baseline (at the time of questionnaire completion)
|
|
Mini-Balance Evaluation Systems Test (Mini-BESTest) Total Score
Time Frame: Baseline (at the time of questionnaire completion)
|
Dynamic balance will be measured using the Mini-Balance Evaluation Systems Test (Mini-BESTest), a 14-item performance-based assessment.
Total scores range from 0 to 28, with higher scores indicating better balance performance.
|
Baseline (at the time of questionnaire completion)
|
|
Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score
Time Frame: Baseline (at the time of questionnaire completion)
|
Quality of life will be measured using the Parkinson's Disease Questionnaire-39 (PDQ-39), a validated disease-specific instrument.
Total scores range from 0 to 100, with higher scores indicating poorer quality of life.
|
Baseline (at the time of questionnaire completion)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
- 2026-03-130
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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