Determination of the Minimal Detectable Change of the Parkinson's Disease Questionnaire-8

NCT06487364 | Recruiting

• 1 other identifier: 2024/78
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson; Minimal Detectable Change; Minimal Clinically Important Difference; Parkinson Disease Questionnaire-8

Outcome Measures

Primary Outcomes (3)

• Parkinson Disease Questionnaire-8

  It is an 8-item form used to assess the quality of life in Parkinson's disease.

  7 days before the Physiotherapy session

• Parkinson Disease Questionnaire-8

  It is an 8-item form used to assess the quality of life in Parkinson's disease.

  First day of the physiotherapy session

• Parkinson Disease Questionnaire-8

  It is an 8-item form used to assess the quality of life in Parkinson's disease.

  6 weeks (5 physiotherapy sessions for 6 weeks)

Secondary Outcomes (4)

• Demographic Data Form

  First day of the physiotherapy session

• Modified Hoehn & Yahr Scale

  First day of the physiotherapy session

• Unified Parkinson's Disease Rating Scale (UPDRS)

  First day of the physiotherapy session

• Global Rating of Patient-Perceived Changes (GRP-PC)

  6 weeks (5 physiotherapy sessions for 6 weeks)

Study Arms (1)

Physiotherapy Group

There will be only one group in the study. Patients will only be applied to the physiotherapy program recommended by the specialist physician and physiotherapist. It is not possible to apply any additional treatment within the scope of the study.

Other: Rehabilitation

Interventions

Rehabilitation OTHER

A routine physical therapy program prescribed by a specialist physician and physiotherapist will be applied.

Physiotherapy Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Parkinson Disease

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emre Şenocak: lead

Study Sites (1)

Private Güney Hospital

Istanbul, 34230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Murat Emirzeoğlu, PhD

  Karadeniz Technical University

  STUDY CHAIR

• Adem Aktürk, PhD

  İstanbul Gelişim University

  STUDY CHAIR

• Tuğba Eyigürbüz, PhD

  Bağcılar Education and Research Hospital

  STUDY CHAIR

Central Study Contacts

Emre Şenocak, PhD

CONTACT

+90 553 569 56 92; emre.senocak@windowslive.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assisstant

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: May 13, 2024
• Primary Completion: January 17, 2025
• Study Completion: September 17, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

TU (1)