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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06487364
Enrollment
39
Registered
2024-07-05
Start date
2024-05-13
Completion date
2025-09-17
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

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

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.

Interventions

OTHERRehabilitation

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

Sponsors

Emre Şenocak
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Parkinson Disease Questionnaire-87 days before the Physiotherapy sessionIt is an 8-item form used to assess the quality of life in Parkinson's disease.

Secondary

MeasureTime frameDescription
Demographic Data FormFirst day of the physiotherapy sessionThis form was created by researchers and it consist of personal informations such as gender, education, age, body mass index, duration of disease
Modified Hoehn & Yahr ScaleFirst day of the physiotherapy sessionIt is used to determine the disease stage. It stages the disease between 1 and 5 points. As the stage progresses, disability also increases.
Unified Parkinson's Disease Rating Scale (UPDRS)First day of the physiotherapy sessionIt 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)
Global Rating of Patient-Perceived Changes (GRP-PC)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).

Countries

Turkey (Türkiye)

Contacts

Primary ContactEmre Şenocak, PhD
emre.senocak@windowslive.com+90 553 569 56 92

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026