NCT07182487

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

September 5, 2025

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Day 1

Secondary Outcomes (4)

  • Sosyodemographic form

    Day 1

  • Modified Hoehn & Yahr (m-HY) scale

    Day 1

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    Day 1

  • Mini Mental State Examination(MMSE)

    Day 1

Study Arms (2)

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)

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü imam University

Kahramanmaraş, Onikişubat, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • hatice adıgüzel tat, Associate Professor

    Kahramanmaras Sutcu Imam University

    STUDY CHAIR
  • Yusuf Şinasi Kırmacı, Asisstant Prof

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR
  • Deniz Tuncel Berktaş, Proffessor

    Kahramanmaras Sutcu Imam University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 19, 2025

Study Start

April 30, 2025

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations