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NCT Number: NCT06490809

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

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.

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Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Özel Öz İstanbul Tıp Merkezi

Istanbul, 34230, Turkey (Türkiye)

Location status: Recruiting

Location contact

Adem Aktürk, PhD

CONTACT

[email protected]

+90 533 310 23 15

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Emre Şenocak, PhD

CONTACT

[email protected]

+90 553 569 56 92

Sponsors and collaborators

Lead sponsor

Emre Şenocak

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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