NCT06591975

Brief Summary

Parkinson's Disease (PD) is the second most common neurodegenerative disease, affecting 2-3% of the population aged 65 and over, characterized by the loss of dopaminergic neurons. The basal ganglia play a significant role in the pathogenesis of PD. The lesions of the basal ganglia impair the ability of patients to perform complex, goal-oriented, and skill-requiring movements. Consequently, motor symptoms such as bradykinesia, rigidity, hypokinesia, and tremor, which are progressively worse, are added to the clinical picture of the disease. These symptoms, which cause movement and activity limitations in individuals with PD, also affect upper extremity functions, balance, and functional mobility. Impairment of upper extremity functions, commonly seen from the early stages of the disease, can affect many basic activities of daily living, including buttoning clothes, tying shoelaces, sewing, writing, eating, and using various modern devices. Balance and mobility disorders are among the most debilitating features of the disease, as they lead to the deterioration of physical functions in PD. Balance and mobility issues in PD are identified as key determinants of the increasing fear of falling and the resulting decline in quality of life. Various factors such as rigidity, bradykinesia, impaired postural adjustments, and decreased sensory integration contribute to the negative impact on balance and mobility in individuals with PD. Proper balance and mobility performance are achieved through synergistic control during both dynamic and static postures between proximal body segments such as the trunk, spine, and pelvis. This contributes to the mobility of distal segments and the functionality of the upper extremities. Additionally, the contribution of upper extremity functions to balance and mobility has been demonstrated in healthy populations. Current literature also reveals that treatment programs targeting the upper extremities can improve mobility and balance, especially in neurological patient populations. In conclusion, balance and mobility disorders in Parkinson's disease can reduce proximal stability and affect hand dexterity. This study aims to examine the relationship between hand dexterity, balance, and functional mobility in individuals with PD.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

September 9, 2024

Last Update Submit

March 17, 2025

Conditions

Keywords

parkinson diseaseupper extremitybalancemobility

Outcome Measures

Primary Outcomes (5)

  • The Nine-Hole Peg Test

    The Nine-Hole Peg Test (9-HPT) will be used to assess upper extremity functions. The 9-HPT evaluates hand dexterity based on performance. The test consists of nine pegs and nine holes (peg length: 32 mm, peg diameter: 7 mm, hole diameter: 7.5 mm, hole depth: 13 mm). In the test, the participant is asked to pick up the pegs one by one and place them into the holes as quickly as possible, and once all the pegs are placed, they are asked to collect them again without delay. The test begins with the command "start" and the test duration is recorded in seconds using a stopwatch. It is performed separately for both the right and left hands. The 9-HPT has been determined to be valid and reliable in individuals with Parkinson's Disease.

    Assessment will be conducted immediately after enrollment.

  • The Berg Balance Scale

    The balance assessment will be conducted using the Berg Balance Scale (BBS). The BBS measures the ability to maintain balance during different positions, postural changes, and movements. It is widely used in Parkinson's Disease (PD) and is a highly reliable and valid scale. The scale consists of 14 tests, each rated on a 4-point scale. The highest score is 56; a score of 0-20 indicates balance impairment (high risk of falling), 21-40 suggests acceptable balance (moderate risk of falling), and 41-56 indicates good balance (low risk of falling). Lower scores point to a loss of static or dynamic balance during daily activities, indicating the presence of a higher risk of falls and functional limitations.

    Assessment will be conducted immediately after enrollment.

  • The Timed Up and Go Test

    Functional mobility will be assessed using the Timed Up and Go Test (TUG). During the test, the individual is asked to rise from a chair, walk 3 meters, turn to the right or left, and then walk back to the chair at a brisk pace without running, and sit down again. The test begins with the command "go" and the time is recorded using a stopwatch. In our study, the TUG will be performed three times, and the best score will be used for analysis. The TUG has been found to be valid and reliable in individuals with Parkinson's Disease (PD).

    Assessment will be conducted immediately after enrollment.

  • The timed 360° turn test

    The timed 360° turn test is an easily administered, not time-consuming, and specific measurement tool to assess turning ability. It measures the time taken for an individual to 360° turn around in a standing position. The timed 360° turn test is also correlated with balance and functional mobility.

    Assessment will be conducted immediately after enrollment.

  • Functional Reach Test

    The Functional Reach Test assesses balance by measuring the limits while the patient reaches forwards as far as possible, having the arms in 90° flexion and without lifting the heels off the floor.

    Assessment will be conducted immediately after enrollment.

Study Arms (1)

Individials with Parkinson's Disease

Parkinson's Disease patients will be included in this study. Inclusion and exclusion criteria will be considered.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referred with a diagnosis of Parkinson's Disease (PD) to the Department of Physiotherapy and Rehabilitation at the University by a specialist physician from the Department of Neurology at the University Medical Faculty Research and Application Hospital will be included in the study

You may qualify if:

  • Having accepted participation in the study after being provided with detailed information about the research
  • Having been diagnosed with only Parkinson's Disease by a specialist physician
  • Having a Standardized Mini-Mental Test score greater than 24
  • Being in stages 1 to 3 according to the Hoehn and Yahr Scale

You may not qualify if:

  • Having any vision, hearing, or perceptual issues that could affect the research outcomes
  • Having an orthopedic problem in the upper extremity that could impact hand dexterity, balance, or mobility
  • Having a cardiovascular, pulmonary, or hormonal disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Milosevic M, McConville KM, Masani K. Arm movement improves performance in clinical balance and mobility tests. Gait Posture. 2011 Mar;33(3):507-9. doi: 10.1016/j.gaitpost.2010.12.005. Epub 2011 Jan 11.

    PMID: 21227695BACKGROUND
  • Kalkan AC, Kahraman T, Ugut BO, Colakoglu BD, Genc A. A comparison of the relationship between manual dexterity and postural control in young and older individuals with Parkinson's disease. J Clin Neurosci. 2020 May;75:89-93. doi: 10.1016/j.jocn.2020.03.018. Epub 2020 Mar 20.

    PMID: 32201026BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

kader eldemir, PT, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

November 15, 2024

Primary Completion

December 15, 2024

Study Completion

March 30, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data but when the statistical analysis of all data is made, all results will be shared.

Locations