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RecruitingNCT06487364Updated Mar 5, 2025

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

An observational study in Parkinson Disease, sponsored by Emre Şenocak. Recruiting at 1 site in Turkey. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Emre Şenocak · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
39
Ages
40 Years to 80 Years
Sex
All
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Study 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.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • Parkinson
  • Minimal Detectable Change
  • Minimal Clinically Important Difference
  • Parkinson Disease Questionnaire-8
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 39 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Emre Şenocak is the lead sponsor of 10 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Parkinson Disease

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
39 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherRehabilitation

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

06

What researchers measure

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)

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Study locations

1 of 1 sites recruiting
  • Private Güney Hospital
    İstanbul, 34230, Turkey
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06487364
Lead sponsor
Emre Şenocak
Responsible party
Emre Şenocak (Research Assisstant, Karadeniz Technical University) — Sponsor-investigator
First posted
Jul 5, 2024
Start date
May 13, 2024
Primary completion
Jan 17, 2025
Completion
Sep 17, 2025 (estimated)
Last update
Mar 5, 2025

Study contacts

Emre Şenocak, PhD
Contact
emre.senocak@windowslive.com
+90 553 569 56 92
Murat Emirzeoğlu, PhD
study chair · Karadeniz Technical University
Adem Aktürk, PhD
study chair · İstanbul Gelişim University
Tuğba Eyigürbüz, PhD
study chair · Bağcılar Education and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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