NCT07488351

Brief Summary

The aim of this study is to evaluate the associations of self-compassion and self-efficacy levels with symptom severity, functional status, and quality of life in individuals with Parkinson's disease.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

March 18, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Self-Compassion Scale (SCS) Total Score

    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

    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

    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 Outcomes (4)

  • Timed Up and Go (TUG) Test Completion Time in Seconds

    Baseline (at the time of questionnaire completion)

  • Six-Minute Walk Test (6MWT) Distance in Meters

    Baseline (at the time of questionnaire completion)

  • Mini-Balance Evaluation Systems Test (Mini-BESTest) Total Score

    Baseline (at the time of questionnaire completion)

  • Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score

    Baseline (at the time of questionnaire completion)

Interventions

This study does not involve any therapeutic intervention. Participants will complete a set of self-report questionnaires assessing self-compassion, self-efficacy, symptom severity, functional status, and quality of life. Data will be collected in a single session for observational analysis.

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of individuals diagnosed with Parkinson's disease who are classified as Hoehn and Yahr stage 1-3, aged between 40 and 85 years, and have sufficient cognitive function (MMSE ≥ 24). Participants will be recruited from patients attending the Movement Disorders Outpatient Clinic of the Neurology Department

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 23, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03