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NCT Number: NCT06591975

The Relationship Between Upper Extremity Function and Balance and Functional Mobility in Parkinson's Disease

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

Location status: Recruiting

Location contact

kader eldemir

CONTACT

About this study

According to the sample size calculation, at least 26 diagnosed PD will be included. Participants' demographic characteristics will be taken initially and the stage will be recorded according to the Hoehn and Yahr Scale. Then, upper extremity functions, balance, and functional mobility will be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. The Nine-Hole Peg Test

    Time frame: Assessment will be conducted immediately after enrollment.

    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.

  2. The Berg Balance Scale

    Time frame: Assessment will be conducted immediately after enrollment.

    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.

  3. The Timed Up and Go Test

    Time frame: Assessment will be conducted immediately after enrollment.

    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).

  4. The timed 360° turn test

    Time frame: Assessment will be conducted immediately after enrollment.

    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.

  5. Functional Reach Test

    Time frame: Assessment will be conducted immediately after enrollment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

kader eldemir, PT, PhD

CONTACT

[email protected]

+903464873152

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Investigation of the Relationship Between Upper Extremity Function and Balance and Functional Mobility in Parkinson's Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Mar 18, 2025

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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