Clinical trial NCT06487364: Determination of the Minimal Detectable Change of the Parkinson's Disease Questionnaire-8
Official title: Determination of the Minimal Detectable Change and Minimum Clinically Important Change Score of the Parkinson's Disease Questionnaire-8
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson
Minimal Detectable Change
Minimal Clinically Important Difference
Parkinson Disease Questionnaire-8
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parkinson Disease

Brief summary: This study is conducted to determine how many units of improvement the Parkinson's Disease Questionnaire-8 (PDQ-8), used to evaluate the quality of life of Parkinson's patients, should have to express a significant change in the quality of life. Patients for whom a 30-session physiotherapy program is recommended will be included in the study. Patients will be asked to express the change in their quality of life at the end of treatment. The PDQ-8 survey and Global Rating of Patient-Perceived Changes (GRP-PC) forms will be used to determine these changes. Evaluations will be repeated at the beginning of the treatment program and at the end of the 30th session.


Eligibility criteria: Inclusion Criteria:

* Having regular neurology follow-up and using medicine;
* Hoehn and Yahr Scale Stage between 1-3 points;
* Mini-Mental State Assessment Score \&gt;24 points;

Exclusion Criteria:

* Having a secondary neurological disease;
* Any surgery and/or trauma affecting the upper extremity
* Having complaints of pain before the treatment program;
* There was a change in medical treatment during the study;
* With symptoms of anxiety and depression;
* Those who use alcohol and drugs;
* Individuals with vision defects that cannot be corrected by the use of glasses and those with hearing loss

Primary outcomes:
measure: Parkinson Disease Questionnaire-8
timeFrame: 7 days before the Physiotherapy session
measure: Parkinson Disease Questionnaire-8
timeFrame: First day of the physiotherapy session
measure: Parkinson Disease Questionnaire-8
timeFrame: 6 weeks (5 physiotherapy sessions for 6 weeks)
Secondary outcomes:
measure: Demographic Data Form
timeFrame: First day of the physiotherapy session
measure: Modified Hoehn & Yahr Scale
timeFrame: First day of the physiotherapy session
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: First day of the physiotherapy session
measure: Global Rating of Patient-Perceived Changes (GRP-PC)
timeFrame: 6 weeks (5 physiotherapy sessions for 6 weeks)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Private Güney Hospital
Study officials:
affiliation: Karadeniz Technical University
name: Murat Emirzeoğlu, PhD
role: STUDY_CHAIR
affiliation: İstanbul Gelişim University
name: Adem Aktürk, PhD
role: STUDY_CHAIR
affiliation: Bağcılar Education and Research Hospital
name: Tuğba Eyigürbüz, PhD
role: STUDY_CHAIR
References: