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

77
On Track

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
8mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress34%
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

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

March 18, 2026

Last Update Submit

July 14, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Self-Compassion Scale (SCS) Total Score

    Self-Compassion Scale (SCS) total score. The Self-Compassion Scale consists of 26 items scored on a 1- to 5-point Likert scale. Total scores range from 1 to 5 (calculated as the mean of all items), with higher scores indicating greater self-compassion (better outcome).

    Baseline (at the time of questionnaire completion)

  • Self-Efficacy for Managing Chronic Disease 6-Item Scale Total Score

    Self-Efficacy for Managing Chronic Disease 6-Item Scale total score. The scale consists of 6 items scored from 1 (not at all confident) to 10 (totally confident). The total score is calculated as the mean of the six items, ranging from 1 to 10, with higher scores indicating greater self-efficacy for managing chronic disease (better outcome).

    Baseline (at the time of questionnaire completion)

  • Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

    Unified Parkinson's Disease Rating Scale (UPDRS) total score. The total score ranges from 0 to 199, with higher scores indicating greater Parkinson's disease severity and worse clinical status (worse outcome).

    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
Healthy VolunteersNo
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:

  • Clinical diagnosis of Parkinson's disease
  • Hoehn and Yahr stage 1-3
  • Age 40 to 85 years
  • Mini-Mental State Examination (MMSE) score ≥24
  • Sufficient cognitive function to communicate and complete study assessments
  • Attending the Movement Disorders Outpatient Clinic, Department of Neurology
  • Able and willing to provide written informed consent

You may not qualify if:

  • Major depressive disorder or psychotic disorder
  • Advanced dementia
  • Uncontrolled chronic systemic disease (e.g., diabetes mellitus or hypertension)
  • Severe cardiovascular or respiratory disease
  • Additional neurological or orthopedic conditions that may affect assessment performance
  • Severe visual or hearing impairment that could interfere with study assessments
  • Inability to cooperate with the physiotherapist during study assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, Turkey, +90, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Nuray Alaca

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

July 15, 2026

Record last verified: 2026-07

Locations