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

NCT06490809 | Recruiting

• 1 other identifier: E-13562490-050.01.04-51
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson; Box and Block Test; Minimal Clinically Important Difference

Outcome Measures

Primary Outcomes (3)

• Box and Block Test

  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

  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)

  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 Outcomes (1)

• Demographic Data Form

  Baseline of the study

Study Arms (1)

Routine Physiotherapy Group

EXPERIMENTAL

No action will be taken by the researchers on this group's treatment program.

Other: Physiotherapy

Interventions

Physiotherapy OTHER

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.

Routine Physiotherapy Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emre Şenocak: lead

Study Sites (1)

Özel Öz İstanbul Tıp Merkezi

Istanbul, 34230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Murat Emirzeoğlu, PhD

  Karadeniz Technical University

  STUDY CHAIR

• Tuğba Eyigürbüz, PhD

  Bağcılar Education and Research Hospital

  STUDY CHAIR

• Adem Aktürk, PhD

  İstanbul Gelişim University

  STUDY CHAIR

Central Study Contacts

Emre Şenocak, PhD

CONTACT

+90 553 569 56 92; emre.senocak@windowslive.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: An independent Researcher will perform a statistical analysis.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assisstant

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 8, 2024
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

TU (1)