PARKINSON DISEASE (Disorder)NCT07182487
Postural Sway of Trunk and Upper Extremity Functional Skills in Atient With Parkinson Disease (pwPD)
An observational study of PARKINSON DISEASE (Disorder) and Postural Instability, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Postural Instability, Trunk Stability Impairment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2025to 15 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü imam University
Kahramanmaraş, Onikişubat, 46100
About this study
Official title: 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.
- Conditions
- PARKINSON DISEASE (Disorder), Postural Instability, Trunk Stability Impairment, Upper Extremity
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Individuals between the ages of 40 and 75 diagnosed with idiopathic Parkinson's disease (n=40±5) | |
| 2 | Healthy individuals between the ages of 40-75 (n=40±5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Gyko Device for postural truk stability
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.
Measured: first day of the assessment
The 9-Hole Peg Test (DDPT)
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.
Measured: Day 1
Secondary outcomes (4)
Sosyodemographic form
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
Measured: Day 1
Modified Hoehn & Yahr (m-HY) scale
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)
Measured: Day 1
Unified Parkinson's Disease Rating Scale (UPDRS)
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).
Measured: Day 1
Mini Mental State Examination(MMSE)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start30 Apr 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
- Investigators
- hatice adıgüzel tat, Associate Professor, Study chair, Kahramanmaras Sutcu Imam UniversityYusuf Şinasi Kırmacı, Asisstant Prof, Principal investigator, Kahramanmaras Sutcu Imam UniversityAsiya Uzun, Asisstant Prof, Study chair, Kahramanmaras Sutcu Imam UniversityAbdulkadir Ertürk, Msc, Study chair, Kahramanmaras Sutcu Imam UniversityTuğçe Simay Özbay, Msc, Study chair, Kahramanmaras Sutcu Imam UniversityBuket Tuğan Yıldız, Associate Professor, Study chair, Kahramanmaras Sutcu Imam UniversityDeniz Tuncel Berktaş, Proffessor, Study chair, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182487
- Sponsor's protocol ID
- Gyko
- Status last verified
- Dec 2025
- First submitted
- 5 Sep 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Postural Sway of Trunk and Upper Extremity Functional Skills in Patients With Parkinson's Disease(pwPD)
- ClinicalTrials.gov ID
- NCT07182487
- Acronym / sponsor ID
- Gyko
- Conditions
- PARKINSON DISEASE (Disorder), Postural Instability, Trunk Stability Impairment, Upper Extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Individuals between the ages of 40 and 75 diagnosed with idiopathic Parkinson's disease (n=40±5) |
| 2 | – | –Healthy individuals between the ages of 40-75 (n=40±5) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Gyko Device for postural truk stability
Time frame: first day of the assessment
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.
The 9-Hole Peg Test (DDPT)
Time frame: Day 1
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.
4 secondary outcomes
Sosyodemographic form
Time frame: Day 1
Modified Hoehn & Yahr (m-HY) scale
Time frame: Day 1
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: Day 1
Mini Mental State Examination(MMSE)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hatice adıgüzel tat, Associate Professor study chair
Kahramanmaras Sutcu Imam University
Yusuf Şinasi Kırmacı, Asisstant Prof principal investigator
Kahramanmaras Sutcu Imam University
Asiya Uzun, Asisstant Prof study chair
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PARKINSON DISEASE (Disorder) and Postural Instability, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Gyko Device for postural truk stability (time frame: first day of the assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.