- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06591975
The Relationship Between Upper Extremity Function and Balance and Functional Mobility in Parkinson's Disease
Investigation of 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: kader eldemir, PT, PhD
- Phone Number: +903464873152
- Email: fztkader2015@gmail.com
Study Locations
-
-
-
Sivas, Turkey
- Recruiting
- Sivas Cumhuriyet University
-
Contact:
- kader eldemir
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Individials with Parkinson's Disease
Parkinson's Disease patients will be included in this study.
Inclusion and exclusion criteria will be considered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Assessment will be conducted immediately after enrollment.
|
|
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.
|
Assessment will be conducted immediately after enrollment.
|
|
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).
|
Assessment will be conducted immediately after enrollment.
|
|
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.
|
Assessment will be conducted immediately after enrollment.
|
|
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.
|
Assessment will be conducted immediately after enrollment.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PD-hand-balance-mobility
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Parkinson Disease
-
Bezmialem Vakif UniversityRecruitingParkinson Disease | Parkinson | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseTurkey (Türkiye)
-
CND Life SciencesDigestive Disease Associates of CTRecruitingParkinson Disease | Parkinson | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
Neuron23 Inc.Roche Diagnostic Ltd.; Qiagen Manchester LimitedRecruitingParkinson Disease | Parkinson | Idiopathic Parkinson Disease | Parkinson Disease, Idiopathic | Early Parkinson Disease (Early PD)United States, Spain, Israel, Poland, Italy, United Kingdom
-
San Francisco Neurology and Sleep CenterRecruitingPARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
Haukeland University HospitalUniversity of Bergen; SPARK NSRecruitingParkinson Disease (PD) | Parkinson s DiseaseNorway
-
Bezmialem Vakif UniversityIstanbul University - CerrahpasaNot yet recruitingParkinson Disease | PARKINSON DISEASE (Disorder) | Parkinson Disease (PD), Postural Balance
-
CND Life SciencesOregon Health and Science UniversityRecruitingParkinson Disease | Parkinson | Parkinson's Disease and Parkinsonism | PARKINSON DISEASE (Disorder)United States
-
Università degli Studi dell'InsubriaUniversidade Nova de Lisboa; Associazione Parkinson Insubria (AsPI), Section... and other collaboratorsRecruitingParkinson Disease | Parkinson | Parkinson Disease, Idiopathic | PARKINSON DISEASE (Disorder)Italy
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
Duke UniversityMedical University of South Carolina; Massachusetts General Hospital; Mayo Clinic and other collaboratorsNot yet recruitingGut Microbiota | Gut Microbiome | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Prodromal Parkinsons DiseaseUnited States