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Completed

NCT Number: NCT07772622

The Validity and Reliability of an Improved Paper Grasping Test for Parkinson's Disease

The study will include volunteer patients diagnosed with Parkinson's disease who applied to the Neurology Outpatient Clinic at SANKO University Sani Konukoğlu Application and Research Hospital.

Patients who meet the inclusion criteria will be evaluated by Dr. Hakan Polat and Physiotherapist Fatma Yılmaz in the application laboratory of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, SANKO University.

The assessment form prepared by the researchers will be completed face-to-face with the patients. First, demographic information and disease-related data (duration since Parkinson's diagnosis, disease stage, affected side, etc.) will be recorded. The Mini-BESTest will be used to evaluate balance and gait. The muscle strength of the ankle plantar flexor and dorsiflexor muscles will be assessed using a manual muscle testing device, and quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).

Since fall problems in patients may be related to balance impairments, lower limb muscle weakness, and reduced quality of life, these parameters will also be evaluated. Therefore, in this study, while examining the validity and reliability of the modified paper grip test in individuals with Parkinson's disease, its correlation with these parameters will also be investigated.

Before administering the tests, participants will receive a practical explanation of how the tests are performed and will be allowed to rest prior to assessment. The tests will be administered in the following order: first, the paper grip test by Dr. Hakan Polat, followed by the Mini-BESTest, assessment of ankle plantar and dorsiflexor muscle strength, and evaluation of quality of life.

One week after the initial assessment, only the paper grip test will be re-administered by Physiotherapist Fatma Yılmaz in the same environment. This approach will minimize the effect of environmental factors on the patients' performance.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanko Unıversıty

Gaziantep, 27090, Turkey (Türkiye)

About this study

Parkinson's disease is one of the most significant neurodegenerative disorders causing disability worldwide. It is characterized by progressive loss of dopaminergic neurons in the substantia nigra, leading to motor symptoms such as bradykinesia, rigidity, tremor, postural instability, and gait disturbances. Symptoms vary depending on disease stage and the affected neural pathways. Common symptoms observed in individuals with Parkinson's disease include muscle weakness, reduced upper limb function, gait difficulties, balance and coordination impairments, and, in some cases, cognitive and communication problems.

Patients with Parkinson's disease are at high risk of falling, particularly due to balance and postural instability. Consequently, fear of falling can lead to kinesiophobia (fear of movement), decreased engagement in activities of daily living, and difficulties in functional adaptation. Balance problems are among the primary motor deficits in Parkinson's disease and contribute significantly to gait disturbances, postural instability, and fall risk. Therefore, balance rehabilitation is a key focus in the management of Parkinson's disease, especially for fall prevention.

A detailed assessment of balance is essential for planning effective rehabilitation programs. According to the literature, balance evaluation in Parkinson's patients is generally performed using static and dynamic assessments. Commonly used tools include the Mini-BESTest, the Functional Reach Test, and the Timed Up and Go Test (TUG). However, a major contributor to balance problems is lower extremity muscle weakness, particularly in the ankle. While research shows a significant relationship between lower limb muscle weakness and increased fall risk in Parkinson's patients, existing assessment tools often lack direct quantitative measurements, which may reduce their clinical effectiveness.

The Enhanced Paper Grip Test (EPGT) can help address this gap. The EPGT provides a simple measurement of hallux plantar flexion strength without requiring specialized equipment. It can be used to assess fall risk in individuals with Parkinson's disease and has been suggested as a practical screening tool in geriatric populations. The validity and reliability of the test have also been demonstrated in individuals diagnosed with multiple sclerosis. The EPGT is easy to administer, requires minimal space, is low-cost, and quick to perform, making it a practical clinical tool. In this study, the researchers aimed to examine the validity and reliability of the modified paper grip test in Parkinson's patients.

Volunteer patients diagnosed with Parkinson's disease who applied to the SANKO University Sani Konukoğlu Application and Research Hospital Neurology Polyclinic will be included in the study. Patients who meet the inclusion criteria will be evaluated by Dr. Hakan Polat and Physiotherapist Fatma Yılmaz in the application laboratory of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, SANKO University. The role of Associate Professor Zekiye İpek Kırmacı in the study includes planning the study, formulating hypotheses, interpreting the results, and preparing the manuscript for publication.

The assessment form prepared by the researchers will be completed face-to-face with patients. First, demographic information and disease-related data (such as disease duration, affected side, and affected limb) will be recorded. Balance and gait will be assessed using the Mini-BESTest. The muscle strength of the ankle plantar and dorsiflexor muscles will be measured using a manual muscle testing device, and quality of life will be evaluated with the Parkinson's Disease Questionnaire-39 (PDQ-39).

Because fall risk in Parkinson's patients may be related to balance impairments, lower limb muscle weakness, particularly in the ankle, and reduced quality of life, these parameters will also be examined. Therefore, in this study, while evaluating the validity and reliability of the modified paper grip test in Parkinson's patients, its correlation with these parameters will also be investigated.

Before administering the tests, participants will receive a practical explanation of the procedures and will be allowed to rest prior to assessment. The order of testing will be as follows: first, the paper grip test performed by Dr. Hakan Polat, followed by the Mini-BESTest, assessment of ankle muscle strength, and evaluation of quality of life.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Individuals aged between 18 and 65 years who have been diagnosed with Parkinson's disease

Individuals who voluntarily agree to participate in the study -

Exclusion criteria

Individuals who are pregnant or within the first three months postpartum

Individuals who have taken any medication affecting walking ability within the last month or who have experienced an orthopedic injury within the last month

-

Treatment and study plan

Primary outcomes

  1. mini best test

    Time frame: Measured once, at baseline (Session 1)

    • Mini Best Test Description: This is one of the clinical tests used to assess walking and balance. It consists of four sub-parameters: preparatory movement, reactive postural control, sensory orientation, and dynamic walking, comprising a total of 14 items. It is a test scored out of a total of 28 points, taking an average of 10-15 minutes to complete. A high score indicates high function.
  2. Manual muscle testing device

    Time frame: Measured once, at baseline (Session 1)

    • Manual muscle testing device Description: muscle strength (right foot dorsiflexion, left foot dorsiflexion, right foot plantar flexion, left foot plantar flexion) will be measured using the Commander Echo brand manual muscle testing device. The participant will be a
  3. Enhanced Paper Grasping Test

    Time frame: Baseline (Session 1) and 1 week later (Session 2)

    Description: During measurement, participants will sit in a calm environment on a chair without armrests, with their feet and knees at a 90-degree angle, and their upper limbs comfortably placed alongside their torso. This test involves

Sponsors and collaborators

Lead sponsor

Sanko University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

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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