Parkinson DiseaseNCT06591975
The Relationship Between Upper Extremity Function and Balance and Functional Mobility in Parkinson's Disease
An observational study of Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 30 Mar 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Cumhuriyet University
Sivas
kader eldemir
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease, upper extremity, balance, mobility
- 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 |
|---|---|---|
| Individials with Parkinson's Disease | Parkinson's Disease patients will be included in this study. Inclusion and exclusion criteria will be considered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Assessment will be conducted immediately after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Nov 2024
- Primary completion15 Dec 2024
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Cross-sectional
- Enrolment
- 26 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kader Eldemir, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591975
- Sponsor's protocol ID
- PD-hand-balance-mobility
- Status last verified
- Mar 2025
- First submitted
- 9 Sep 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 21227695Kalkan 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.
PubMed 32201026
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Upper Extremity Function and Balance and Functional Mobility in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06591975
- Acronym / sponsor ID
- PD-hand-balance-mobility
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease, upper extremity, balance, mobility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 19 Sep 2024 (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, 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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individials with Parkinson's Disease | – | –Parkinson's Disease patients will be included in this study. Inclusion and exclusion criteria will be considered. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 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.
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.
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).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 21227695Milosevic 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.
- Background: PubMed 32201026Kalkan 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.
- Individual participant dataSharing planned: No. 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.
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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.
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, run by Gazi 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kader eldemir, PT, PhD (+903464873152, fztkader2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Nine-Hole Peg Test (time frame: Assessment will be conducted immediately after enrollment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06591975, which also lists 2 linked publications.
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 18 Mar 2025; AzTrials last refreshed its copy on 27 Oct 2026.