- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07182487
- Original Trial
Postural Sway of Trunk and Upper Extremity Functional Skills in Atient With Parkinson Disease (pwPD)
December 18, 2025 updated by: Hatice Adiguzel, Kahramanmaras Sutcu Imam University
Relationship Between Postural Sway of Trunk and Upper Extremity Functional Skills in Patients With Parkinson's Disease(pwPD)
Parkinson's disease (PD) is the second most common neurodegenerative disease, characterized clinically by motor and non-motor symptoms, including bradykinesia, resting tremor, and/or rigidity.
Among the motor deficits observed in PD, decreased postural control often results in decreased balance.
Furthermore, losses in many upper extremity and manual skills are also observed in PD.
Loss of postural control is one of the key motor symptoms observed in the advanced stages of PD, increasing the risk of falls.
Analysis of postural control deficits is critical for assessing disease progression and treatment planning in PD.
In this context, gyroscope-based motion analysis systems are used as a reliable method for assessing trunk sway.Sensory deficits, such as decreased spatial and temporal tactile discrimination thresholds in the fingertips, are also observed in PD.
Reaching and grasping deficits are more common when patients have significant difficulty initiating movements toward a target.
These patients exhibit deficits in manipulating the hand relative to object geometry.
A loss of coordination between reach and grasp timing is observed.
These patients generally rely on visual cues to control movement.
They experience difficulties in optimal object manipulation due to difficulties planning finger placement.Studies have shown a strong relationship between postural control and fine motor functions.
For high-quality distal movement, better proximal stabilization is necessary.
During upper extremity functions, the body's center of gravity must shift with arm movements, allowing adaptation to changing gravity.
Good trunk control is essential for this dynamic process of maintaining balance.
Studies examining this link between trunk control, balance, and hand functions are available in the literature.
Among these studies conducted in diverse populations, studies involving PD are very few.
In light of this information, our study was designed to investigate the relationship between postural trunk sway and hand dexterity in PD.
Therefore, the aim of this study was to determine the relationship between postural sway and upper extremity functional abilities in PD.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Onikişubat
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Kahramanmaraş, Onikişubat, Turkey (Türkiye), 46100
- Kahramanmaras Sutcu Imam University
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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
Yes
Sampling Method
Probability Sample
Study Population
Individuals aged between 40 and 75 years (n=40±5) who applied to the Neurology Clinic of the Faculty of Medicine of KSÜ Training and Research Hospital, diagnosed with Idiopathic Parkinson's disease (PD) by a neurologist, having stage ≤4 on the Modified Hoehn&Yahr (m-HY) scale, and having scores of ≥22 in the educated and ≥18 in the uneducated according to the Mini Mental State Examination, and healthy individuals of a similar age group (n=40±5)
Description
Inclusion Criteria:
- Healthy individuals aged 40-75 years, diagnosed with idiopathic PD according to the UK Parkinson's Disease Association Brain Bank criteria by a specialist neurologist, with a Modified Hoehn & Yahr (m-HY) scale stage ≤4, and with a Mini Mental State Examination score of ≥22 for those with training and ≥18 for those without training, and with no known disease, volunteered to participate in the study.
- Individuals with no other known neurological and/or systemic disease
- Individuals without any upper extremity contractures
Exclusion Criteria:
- Individuals with severe balance and walking difficulties
- Individuals with diagnosed and/or treated psychiatric illnesses who are considered unable to complete the required tests
- Those taking neuroleptic medications or antidepressants
- Individuals with orthopedic conditions that interfere with manual dexterity tests, such as severe dyskinesia, carpal tunnel syndrome, tendon injuries, or finger amputations; rheumatological diseases such as rheumatoid arthritis and osteoarthritis; and individuals with any neurological disease other than PD
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
Cohorts and Interventions
Group / Cohort |
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1
Individuals between the ages of 40 and 75 diagnosed with idiopathic Parkinson's disease (n=40±5)
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2
Healthy individuals between the ages of 40-75 (n=40±5)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Gyko Device for postural truk stability
Time Frame: first day of the assessment
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This device, manufactured by Mikrogate and manufactured in Italy, is used as a portable inertial measurement unit for motion analysis and postural stability assessment.
A sensor placed on a sling is used to analyze the displacement of the patient's center of gravity using a computer.
The patient is asked to walk for 30 seconds.
The data collected includes postural data such as sway length and area, sway excursion speed, and sway frequency.
Studies have shown that the device has high absolute and relative reliability and provides measurements consistent with other validation methods .
The device's ease of use and portability make it preferred in clinical and sports settings.
Furthermore, the data accuracy it provides across different ground conditions and movement patterns has contributed to its widespread acceptance.
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first day of the assessment
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The 9-Hole Peg Test (DDPT)
Time Frame: Day 1
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The 9-Hole Peg Test (DDPT) is a validated test for PD that measures manual dexterity in seconds based on performance (21).
The test material consists of nine standard-sized small rods and a nine-hole platform on which to place them.
The test will be administered with the patient in a sitting position.
The patient will be asked to place nine rods in the round compartment of the box as quickly as possible into the holes of the box, starting from the edge farthest from the compartment and immediately withdraw them from the edge closest to the compartment.
The test will begin with the dominant hand, and the time will be measured with a stopwatch, starting when the hand touches the rods and ending when the last rod is placed in the box.
The same procedure will be applied to the other hand.
In this study, the arithmetic mean of the test times, repeated twice, will be recorded separately for each hand.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sosyodemographic form
Time Frame: Day 1
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Medical history (disease duration and symptoms), demographic information (age, height, weight, education level), habits, medications, level of dependency in mobility in daily life, use of assistive devices
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Day 1
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Modified Hoehn & Yahr (m-HY) scale
Time Frame: Day 1
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PD disability will be assessed with the m-HY scale: stage 1.0 (unilateral involvement only); stage 1.5 (unilateral and axial involvement); stage 2.0 (bilateral involvement without balance impairment); stage 2.5 (mild bilateral disease with improvement in the pull test); stage 3.0 (mild to moderate bilateral disease; some postural impairment; physically independent); stage 4.0 (severe disability; still able to walk or stand unaided).
Symptom severity in PD was graded using the Unified Parkinson's Disease Rating Scale (UPDRS): part I (mental dysfunction and mood); part II (activities of daily living); part III (motor component); part IV (treatment-related complications)
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Day 1
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Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: Day 1
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Symptom severity in PD is rated using the Unified Parkinson's Disease Rating Scale (UPDRS).
Several items on this scale assess upper extremity and hand function.
The Activities of Daily Living section assesses handwriting, cutting food, and grasping utensils.
The Motor section assesses finger tapping, hand movements, and rapid alternating hand movements.
These test items are scored from 0 to 4, with 4 representing maximum impairment and 0 representing normal movement ability.
The UPDRS is comprised of subsections: Section I (mental dysfunction and mood); Section II (activities of daily living); Section III (motor); and Section IV (treatment-related complications).
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Day 1
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Mini Mental State Examination(MMSE)
Time Frame: Day 1
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The test was developed by Folstein in 1975.
Its Turkish validity and reliability study was conducted by Güngen et al. in 2002.
The Mini Mental State Examination (MMSE), which assesses cognitive functions in five separate sections (orientation, registration, attention and calculation, recall, and language), is frequently used and is quite suitable for screening cognitive function in the elderly.
A score below 24 on the MMSE indicates dementia, 24-26 indicates mild cognitive impairment, and 26 or above indicates normal cognitive function.
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Deniz Tuncel Berktaş, Proffessor, Kahramanmaras Sutcu Imam University
- Study Chair: hatice adıgüzel tat, Associate Professor, Kahramanmaras Sutcu Imam University
- Principal Investigator: Yusuf Şinasi Kırmacı, Asisstant Prof, Kahramanmaras Sutcu Imam University
- Study Chair: Asiya Uzun, Asisstant Prof, Kahramanmaras Sutcu Imam University
- Study Chair: Abdulkadir Ertürk, Msc, Kahramanmaras Sutcu Imam University
- Study Chair: Tuğçe Simay Özbay, Msc, Kahramanmaras Sutcu Imam University
- Study Chair: Buket Tuğan Yıldız, Associate Professor, Kahramanmaras Sutcu Imam University
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)
April 30, 2025
Primary Completion (Actual)
December 15, 2025
Study Completion (Actual)
December 15, 2025
Study Registration Dates
First Submitted
September 5, 2025
First Submitted That Met QC Criteria
September 18, 2025
First Posted (Estimated)
September 19, 2025
Study Record Updates
Last Update Posted (Actual)
December 19, 2025
Last Update Submitted That Met QC Criteria
December 18, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gyko
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.
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