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

ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-80
SponsorEmre Şenocak

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Having regular neurology follow-up and using medicine;

Hoehn and Yahr Scale Stage between 1-3 points;

Mini-Mental State Assessment Score >24 points;

Disqualifiers

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;

Trial population

Parkinson Disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Rehabilitation

    Other intervention

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

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: Physiotherapy Group1 intervention

Trial outcomes

Primary outcomes

1

Parkinson Disease Questionnaire-8

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

Time frame
7 days before the Physiotherapy session
2

Parkinson Disease Questionnaire-8

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

Time frame
First day of the physiotherapy session
3

Parkinson Disease Questionnaire-8

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

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

Secondary outcomes

1

Demographic Data Form

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

Time frame
First day of the physiotherapy session
2

Modified Hoehn & Yahr Scale

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

Time frame
First day of the physiotherapy session
3

Unified Parkinson's Disease Rating Scale (UPDRS)

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)

Time frame
First day of the physiotherapy session
4

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

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).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emre Şenocak

Lead sponsor

Karadeniz Technical University

Sponsor institution

Source ClinicalTrials.gov
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