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NCT Number: NCT06487364

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

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

rehabilitation

Other

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

Primary outcomes

  1. Parkinson Disease Questionnaire-8

    Time frame: 7 days before the Physiotherapy session

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

  2. Parkinson Disease Questionnaire-8

    Time frame: First day of the physiotherapy session

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

  3. Parkinson Disease Questionnaire-8

    Time frame: 6 weeks (5 physiotherapy sessions for 6 weeks)

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

Secondary outcomes

  1. Demographic Data Form

    Time frame: First day of the physiotherapy session

    This form was created by researchers and it consist of personal informations such as gender, education, age, body mass index, duration of disease

  2. Modified Hoehn & Yahr Scale

    Time frame: First day of the physiotherapy session

    It is used to determine the disease stage. It stages the disease between 1 and 5 points. As the stage progresses, disability also increases.

  3. Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: First day of the physiotherapy session

    It can assess Parkinson's disease with its different clinical features, including motor and non-motor. It consists of 4 subsections and 55 items in total. This study will use part III of the UPDRS score (between subsections 3.1 and 3.18)

  4. Global Rating of Patient-Perceived Changes (GRP-PC)

    Time frame: 6 weeks (5 physiotherapy sessions for 6 weeks)

    GRP-PC will used to assess patient-perceived hand dexterity changes after the routine intervention. The patient will first asked, "Has your hand dexterity changed compared to when you did not receive interventions?". If the answer is no, the person will given a score of 0 (i.e. no change). In the case of positive response, the patient will asked, "How much better or worse is your hand dexterity" and the patient response will scored on the following 14-point Likert scale: +7 (very much better), +6 (much better), +5 (better), +4 (relatively better), +3 (somewhat better), +2 (a little better), +1 (very little better), -1 (very little worse), -2 (a little worse), -3 (somewhat worse), -4 (relatively worse), -5 (worse), -6 (much worse), and -7 (very much worse).

Study contacts

Contact information is provided by the study sponsor or research team.

Emre Şenocak, PhD

CONTACT

[email protected]

+90 553 569 56 92

Sponsors and collaborators

Lead sponsor

Emre Şenocak

Other

Registry information

Official study title

Determination of the Minimal Detectable Change and Minimum Clinically Important Change Score of the Parkinson's Disease Questionnaire-8

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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