Parkinson DiseaseNCT06146283
The Relationship Between Trunk Control and Hand Functions in Individuals With Parkinson's
An observational study of Parkinson Disease, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
The trunk, which plays an integral role in postural stabilization, controls extremity movements by providing dynamic stabilization during performance. Trunk stability is thought to be a prerequisite for upper extremity functions and it is assumed that trunk control has an effect on hand functions. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Jamar Hydraulic Hand Dynamometer
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We included individuals diagnosed with Parkinson's between the ages of 40-70.
Who may be able to join
- between the ages of 40 and 70,
- Being diagnosed with Parkinson's disease by a neurologist,
- Having a Mini Mental Test score of 24 and above,
- Modified Hoehn Yahr Scale score is 2 or less than 2,
- Having no additional neurological or orthopedic disease
Who cannot join
- Individuals with advanced cognitive problems and aphasia,
- Individuals with additional neurological disorders,
- Individuals who refuse to participate in the study,
- Individuals with vision and hearing problems will not be included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sanko University
Gaziantep, Şehitkamil, 27500
Nursena Kılıç, +905331549086, nursena.kilic@sankotip.com
About this study
The trunk, which plays an integral role in postural stabilization, controls extremity movements by providing dynamic stabilization during performance. Trunk stability is thought to be a prerequisite for upper extremity functions and it is assumed that trunk control has an effect on hand functions. There is thought to be a strong relationship between postural control and fine motor functions. There are very few studies in the literature examining the effect of trunk control on hand functions in Parkinson's patients. Based on this, the aim of this study is; To investigate the relationship between trunk control and hand functions.
- Hypotheses of the study;
- Ho: There is no relationship between Trunk Control and hand functions in individuals with Parkinson's disease.
- H1: There is a relationship between Trunk Control and hand functions in individuals with Parkinson's disease
Read the detailed description
Parkinson's Disease (PD) is a progressive and neurodegenerative central nervous system disease characterized by loss of dopaminergic neurons in the substantia nigra. Rest tremor, bradykinesia, rigidity and postural instability are the four basic findings of Parkinson's disease. The progression of the disease varies from person to person, generally starting with unilateral findings, and after the third year, bilateral findings appear and progress from distal to proximal. Balance and postural control disorders also occur within two or three years. The first symptom seen in 80% of patients is rest tremor, which begins in the distal upper extremities. The trunk, which plays an integral role in postural stabilization, controls extremity movements by providing dynamic stabilization during performance. Trunk stability is thought to be a prerequisite for upper extremity functions and it is assumed that trunk control has an effect on hand functions. There is thought to be a strong relationship between postural control and fine motor functions. There are very few studies in the literature examining the effect of trunk control on hand functions in Parkinson's patients. Based on this, the aim of this study is; To investigate the relationship between trunk control and hand functions. Sociodemographic information will be recorded taking into account the answers to the questions in the personal information form prepared by the researcher. Parkinson's patients who meet the inclusion criteria; Rough Grip (Jamar Dynamometer), Nine Hole Peg Test (DDPT), Hoehn and Yahr Scale (HYÖ), Mini Mental Test, Quick-DASH, Duruöz Hand Index and Trunk Impairment Scale (GBÖ) will be performed by Physiotherapist Nursena KILIÇ.
As descriptive statistics; Mean and standard deviation or median and minimum-maximum values will be given for continuous variables specified by measurement, and frequency and percentage values will be given for qualitative variables. The suitability of continuous variables to normal distribution will be evaluated with the Kolmogorov-Smirnov test. In independent group comparisons; For continuous variables specified by measurement, if parametric test conditions are met, the significance test of the difference between two means or one-way ANOVA will be used. In cases where parametric test conditions are not met, Mann-Whitney U test or Kruskal-Wallis test will be used. In dependent measurement comparisons, the significance test of the difference between two pairs will be used for normally distributed data, and the Wilcoxon paired two sample test will be used for non-normally distributed data. The relationship between two continuous variables will be evaluated with Pearson or Spearman Rank correlation coefficients. p<0.05 was considered statistically significant
- Conditions
- Parkinson Disease
- Being tested
- Jamar Hydraulic Hand Dynamometer
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jamar Hydraulic Hand DynamometerCombination product
This device measures hand grip strength. The individual should be in an upright sitting position. There should be no arm support on the sitting surface. ...
The knee angle should be 90 degrees. Elbow angle should be 90 degrees. The wrist should be held without deviation. The measurement should be performed 3 times with an interval of 10 seconds.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine Hole Peg Test (9DPT)
Nine Hole Peg Test (9DPT): It is a valid and reliable skill test frequently used to evaluate upper extremity function.
Measured: 1 weeks
Hand Grip Strength Measurement
Hand Grip Strength Measurement: It is recommended by the American Association of Hand Therapists (AETD) for measuring hand grip strength and has been found to have high validity and reliability in many studies and is therefore considered the gold standard.
Measured: 1 weeks
Hoehn and Yahr Scale (HYS)
Hoehn and Yahr Scale (HYS):t is a staging system developed by Hoehn and Yahr that provides information in a short time in determining the degree and symptoms of the disease in individuals with Parkinson's disease. The scale value is between 1-5
Measured: 1 weeks
Mini Mental Test (MMT)
Mini Mental Test (MMT):The test was produced as a cognitive assessment tool that takes a short time to apply in the examination of the elderly, especially the elderly with delirium and/or dementia, since the tests used to quantitatively evaluate cognitive performance within standard neuropsychiatric examination methods contain too many questions and take more than 30 minutes to apply.
Measured: 1 weeks
Quick-DASH
Quick-DASH:It is an evaluation questionnaire that measures activity and participation limitations in all upper extremity disorders. In the survey, patients' difficulties during daily living activities are questioned with 11 questions. Each question has 5 answer options according to difficulty level. If the patient can do the activity without difficulty, he/she marks 1, if he/she has mild difficulty, 2, if he/she has moderate difficulty, 3, if he/she has extreme difficulty, 4, and if he/she cannot do it at all, he/she marks option 5.
Measured: 1 weeks
Duruöz Hand Index
Duruöz Hand Index:It consists of 18 questions filled out by patients to evaluate hand disability. This scale includes questions divided into 5 categories: kitchen chores, dressing, personal hygiene, workplace and other activities. Answers are scored as: I don't have difficulty (=0), I have little difficulty (=1), I have some difficulty (=2), I have great difficulty (=3), it is almost impossible to do it (=4), I definitely cannot do it (=5). The total score consists of the sum of all scores. (0-90). High scores indicate impaired hand functions
Measured: 1 weeks
Trunk Impairment Scale
Trunk Impairment Scale:This scale consists of three subscales; static-dynamic sitting balance and trunk coordination. GDS value varies between 0-23 and a high score indicates good trunk control.
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Jun 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursena Kılıç, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146283
- Sponsor's protocol ID
- fztnursenakiliç
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Trunk Control and Hand Functions in Individuals With Parkinson's
- ClinicalTrials.gov ID
- NCT06146283
- Acronym / sponsor ID
- fztnursenakiliç
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 24 Nov 2023 (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.
The trunk, which plays an integral role in postural stabilization, controls extremity movements by providing dynamic stabilization during performance. Trunk stability is thought to be a prerequisite for upper extremity functions and it is assumed that trunk control has an effect on hand functions. There is thought to be a strong relationship between postural control and fine motor functions. There are very few studies in the literature examining the effect of trunk control on hand functions in Parkinson's patients. Based on this, the aim of this study is; To investigate the relationship between trunk control and hand functions.
- Hypotheses of the study;
- Ho: There is no relationship between Trunk Control and hand functions in individuals with Parkinson's disease.
- H1: There is a relationship between Trunk Control and hand functions in individuals with Parkinson's disease
Detailed description
Parkinson's Disease (PD) is a progressive and neurodegenerative central nervous system disease characterized by loss of dopaminergic neurons in the substantia nigra. Rest tremor, bradykinesia, rigidity and postural instability are the four basic findings of Parkinson's disease. The progression of the disease varies from person to person, generally starting with unilateral findings, and after the third year, bilateral findings appear and progress from distal to proximal. Balance and postural control disorders also occur within two or three years. The first symptom seen in 80% of patients is rest tremor, which begins in the distal upper extremities. The trunk, which plays an integral role in postural stabilization, controls extremity movements by providing dynamic stabilization during performance. Trunk stability is thought to be a prerequisite for upper extremity functions and it is assumed that trunk control has an effect on hand functions. There is thought to be a strong relationship between postural control and fine motor functions. There are very few studies in the literature examining the effect of trunk control on hand functions in Parkinson's patients. Based on this, the aim of this study is; To investigate the relationship between trunk control and hand functions. Sociodemographic information will be recorded taking into account the answers to the questions in the personal information form prepared by the researcher. Parkinson's patients who meet the inclusion criteria; Rough Grip (Jamar Dynamometer), Nine Hole Peg Test (DDPT), Hoehn and Yahr Scale (HYÖ), Mini Mental Test, Quick-DASH, Duruöz Hand Index and Trunk Impairment Scale (GBÖ) will be performed by Physiotherapist Nursena KILIÇ.
As descriptive statistics; Mean and standard deviation or median and minimum-maximum values will be given for continuous variables specified by measurement, and frequency and percentage values will be given for qualitative variables. The suitability of continuous variables to normal distribution will be evaluated with the Kolmogorov-Smirnov test. In independent group comparisons; For continuous variables specified by measurement, if parametric test conditions are met, the significance test of the difference between two means or one-way ANOVA will be used. In cases where parametric test conditions are not met, Mann-Whitney U test or Kruskal-Wallis test will be used. In dependent measurement comparisons, the significance test of the difference between two pairs will be used for normally distributed data, and the Wilcoxon paired two sample test will be used for non-normally distributed data. The relationship between two continuous variables will be evaluated with Pearson or Spearman Rank correlation coefficients. p<0.05 was considered statistically significant
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included individuals diagnosed with Parkinson's between the ages of 40-70.
Key inclusion criteria (5 listed)
- between the ages of 40 and 70,
- Being diagnosed with Parkinson's disease by a neurologist,
- Having a Mini Mental Test score of 24 and above,
- Modified Hoehn Yahr Scale score is 2 or less than 2,
- Having no additional neurological or orthopedic disease
Key exclusion criteria (4 listed)
- Individuals with advanced cognitive problems and aphasia,
- Individuals with additional neurological disorders,
- Individuals who refuse to participate in the study,
- Individuals with vision and hearing problems will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jamar Hydraulic Hand DynamometerThis device measures hand grip strength. The individual should be in an upright sitting position. There should be no arm support on the sitting surface. ... The knee angle should be 90 degrees. Elbow angle should be 90 degrees. The wrist should be held without deviation. The measurement should be performed 3 times with an interval of 10 seconds. | Combination product | – |
Primary outcome
Nine Hole Peg Test (9DPT)
Time frame: 1 weeks
Nine Hole Peg Test (9DPT): It is a valid and reliable skill test frequently used to evaluate upper extremity function.
Hand Grip Strength Measurement
Time frame: 1 weeks
Hand Grip Strength Measurement: It is recommended by the American Association of Hand Therapists (AETD) for measuring hand grip strength and has been found to have high validity and reliability in many studies and is therefore considered the gold standard.
Hoehn and Yahr Scale (HYS)
Time frame: 1 weeks
Hoehn and Yahr Scale (HYS):t is a staging system developed by Hoehn and Yahr that provides information in a short time in determining the degree and symptoms of the disease in individuals with Parkinson's disease. The scale value is between 1-5
Mini Mental Test (MMT)
Time frame: 1 weeks
Mini Mental Test (MMT):The test was produced as a cognitive assessment tool that takes a short time to apply in the examination of the elderly, especially the elderly with delirium and/or dementia, since the tests used to quantitatively evaluate cognitive performance within standard neuropsychiatric examination methods contain too many questions and take more than 30 minutes to apply.
Quick-DASH
Time frame: 1 weeks
Quick-DASH:It is an evaluation questionnaire that measures activity and participation limitations in all upper extremity disorders. In the survey, patients' difficulties during daily living activities are questioned with 11 questions. Each question has 5 answer options according to difficulty level. If the patient can do the activity without difficulty, he/she marks 1, if he/she has mild difficulty, 2, if he/she has moderate difficulty, 3, if he/she has extreme difficulty, 4, and if he/she cannot do it at all, he/she marks option 5.
Duruöz Hand Index
Time frame: 1 weeks
Duruöz Hand Index:It consists of 18 questions filled out by patients to evaluate hand disability. This scale includes questions divided into 5 categories: kitchen chores, dressing, personal hygiene, workplace and other activities. Answers are scored as: I don't have difficulty (=0), I have little difficulty (=1), I have some difficulty (=2), I have great difficulty (=3), it is almost impossible to do it (=4), I definitely cannot do it (=5). The total score consists of the sum of all scores. (0-90). High scores indicate impaired hand functions
Trunk Impairment Scale
Time frame: 1 weeks
Trunk Impairment Scale:This scale consists of three subscales; static-dynamic sitting balance and trunk coordination. GDS value varies between 0-23 and a high score indicates good trunk control.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Sanko 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nursena kiliç (+905331549086, nursena.kilic@sankotip.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine Hole Peg Test (9DPT) (time frame: 1 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2023.