Minimal Clinically Important Difference of the Box and Block Test in Parkinson

March 4, 2025 updated by: Emre Şenocak

Examining the Clinical Significance of the Change in Manual Dexterity of Parkinson's Patients Receiving Conventional Physiotherapy

The aim of this study is to examine the level of clinical change in gross manual skills of Parkinson's patients who receive conventional physiotherapy. For this purpose, the Box-Block Test will be used, and the amount of change that must occur in the patient's hand functions will be determined for the test to be considered clinically meaningful.

Patients will continue their routine physical therapy sessions and the researchers will not interfere with this program. The treatment program will be created by the clinical specialist physician and physiotherapist.

Upper extremity rehabilitation programs for Parkinson's patients generally consist of methods such as stretching, strengthening, reaching, coordination and recreational activities. Patients will receive physiotherapy for 30 sessions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • İstanbul, Turkey, 34230
        • Recruiting
        • Özel Öz İstanbul Tıp Merkezi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being Hoehn & Yahr Stage between 1-3,
  • Individuals in the "On" phase,
  • Those who were not exposed to any physiotherapy intervention during the initial assessment

Exclusion Criteria:

  • Mini-mental status assessment < 24 points;
  • Presence of severe dyskinesia,
  • Those who experience fluctuations in the on-off phase,
  • Those who have undergone stereotaxic brain surgery for Parkinson's,
  • Individuals with changes in dopamine dose within three months,
  • Presence of unstable cardiac and respiratory disease
  • Those with an orthopedic problem or a history of surgery affecting upper extremity performance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Routine Physiotherapy Group
No action will be taken by the researchers on this group's treatment program.
Other: Physiotherapy
Parkinson's upper extremity rehabilitation generally consists of stretching, strengthening, coordination, recreational activities and skill activities. Exercises will be prescribed by the clinical specialist physician and physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block Test
Time Frame: Baseline of the study
This test assesses gross manual dexterity. The number of wooden blocks moved during 60 seconds gives the total score. A high score indicates good dexterity.
Baseline of the study
Box and Block Test
Time Frame: 6 weeks (5 session days for 6 weeks)
This test assesses gross manual dexterity. The number of wooden blocks moved during 60 seconds gives the total score. A high score indicates good dexterity.
6 weeks (5 session days for 6 weeks)
Global Rating of Patient-Perceived Changes (GRP-PC)
Time Frame: 6 weeks (5 session days 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). This form will only be used to classify patients' satisfaction with treatment at the end of the study.
6 weeks (5 session days for 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Data Form
Time Frame: Baseline of the study
This form was created by researchers and it consist of personal informations such as gender, education, age, body mass index, dominant and affected extremity, disease duration, using medicine
Baseline of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emre Şenocak

Investigators

  • Study Chair: Murat Emirzeoğlu, PhD, Karadeniz Technical University
  • Study Chair: Adem Aktürk, PhD, Istanbul Gelisim University
  • Study Chair: Tuğba Eyigürbüz, PhD, Bağcılar Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-13562490-050.01.04-51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe