Essential TremorNCT05244863
The Relationship of Muscle Strength With Functional Skills in Geriatric Individuals With Essential Tremor
An observational study of Essential Tremor, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Essential tremor is one of the most common movement disorders in the world and is characterized by postural and/or kinetic tremor. Although the prevalence studies show differences due to the absence of a biological marker of the disease, it has been shown that the disease affects 4% of the population over 40 years of… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Test
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 15 Mar 2021
- 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 60 to 85 years
- All sexes
- Adult, Older adult
Study population: geriatric individuals with and without tremor
Who may be able to join
- Voluntary geriatric individuals aged 60-85 years with and without tremor
- with a mini mental test score above 24,
Who cannot join
- have diabetic neuropathy
- have undergone hand surgery
- upper and lower motor paralysis
- a history of hand fracture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sutcu Imam University
Kahramanmaraş
About this study
Official title: The Relationship of Proximal and Distal Muscle Strength With Upper Extremity Functional Skills in Geriatric Individuals With Essential Tremor
Essential tremor is one of the most common movement disorders in the world and is characterized by postural and/or kinetic tremor.
Although the prevalence studies show differences due to the absence of a biological marker of the disease, it has been shown that the disease affects 4% of the population over 40 years of age and this rate may increase up to 14% in the population over 65 years of age. The annual incidence of Essential Tremor was found to be 616 per 100 thousand.
Read more
The incidence of the disease increases with age. An incidence study shows that the disease increases progressively with age, with a sharp increase after age 49. In another study, it was stated that the age of onset of the disease showed a bimodal distribution, reaching the highest level in the second and sixth decades. It is stated that the severity and disability of tremor increase with age. The female-to-male ratio of the disease was found to be equal, but it was shown that more head tremor developed in females.
Although the factors affecting essential tremor are aging, stress, family history, excessive caffeine consumption, smoking, muscle weakness, distal and proximal muscle strength differences were detected in young individuals with tremor. The aim of this study was to investigate the relationship between proximal and distal muscle strength and upper extremity functional skills in geriatric individuals with essential tremor.
Read the detailed description
In order for many elderly individuals to maintain their independence in functional activities, it is critical that the upper extremity dexterity is at a good level. Because the upper extremity needs to be functional in the realization of social relations such as writing, cooking, combing their hair, brushing their teeth, and participating in recreational activities. Due to the importance of maintaining functional independence in old age, many reviews have attempted to identify primary age-related neuromuscular changes that have an impact on the decreased function of most of the elderly. Age-related declines in function can be explained by increased motor unit firing rate variability of various central and peripheral nervous systems. It is thought to increase tremor in the altered synchronization between motor units in agonist and antagonist muscles, as well as impaired activation between agonist and antagonist muscles. Muscle strength differences in upper extremity functional skills were detected between proximal and distal muscle groups in young individuals with Essential Tremor. In a study investigating the effect of resistance exercise training on tremor in geriatrics, the changes in postural tremor with resistance training in healthy older adults were investigated. In this study; The frequency and severity of tremor of two different groups that received strength and coordination training were evaluated, and it was stated that there was a significant difference in the strength training group.
In this study, which is the only literature study in which strength training was applied to geriatric individuals with essential tremor, it was not specified on which muscle groups the strength training would be effective. In our study, determining the strength differences of the proximal and distal muscle groups of geriatric individuals with essential tremor will enable the creation of effective programs specific to the individual and muscle groups in the rehabilitation program.
- Conditions
- Essential Tremor
- Being tested
- Test
- Keywords
- muscle strength, Geriatric individuals, Functional manual dexterity
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestOther
Measurements
| Study group | Role | What they receive |
|---|---|---|
| One group | Geriatric individuals Receives: Other: Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
ahn-Tolosa-Marin Tremor Rating Scale
It is a widely used clinical assessment scale for tremor. The severity of tremor body parts is determined as 5 grades from 0 (absent) to 4 (severe)
Measured: At baseline
Proximal muscle strength
Digital dynamometer was used to evaluate muscle strength.
Measured: At baseline
Dİstal muscle strength
Jamar dynamometer was used to evaluate muscle strength.
Measured: At baseline
Disability Arm Shoulder Hand
The DASH-T questionnaire is completed by the individual and consists of 3 parts: the functional/symptom (DASH-FS), the business model (DASH-W), and the sports-musicians model (DASH-SM). The person answers all questions according to a 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not able to do at all). A score between 0-100 is obtained from each section. The higher the score, the higher the disability.
Measured: At baseline
Nine Holes Peg test
The test is performed with the patient in a sitting position. The patient is asked to line up the nine sticks inside the box on the table as quickly as possible into the holes of the other box, and remove them immediately after finishing. The test is started with the dominant hand, the time is measured with a stopwatch, and it is started when the hand touches the bars and ends when the last stick is placed in the box.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start15 Mar 2020
- Primary completion1 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University
- Investigators
- Zekiye İpek Katırcı Kırmacı, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244863
- Sponsor's protocol ID
- zipekkatirci
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Proximal and Distal Muscle Strength With Upper Extremity Functional Skills in Geriatric Individuals With Essential Tremor
- ClinicalTrials.gov ID
- NCT05244863
- Acronym / sponsor ID
- zipekkatirci
- Conditions
- Essential Tremor
- Keywords
- muscle strength, Geriatric individuals, Functional manual dexterity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 17 Feb 2022 (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.
Essential tremor is one of the most common movement disorders in the world and is characterized by postural and/or kinetic tremor.
Although the prevalence studies show differences due to the absence of a biological marker of the disease, it has been shown that the disease affects 4% of the population over 40 years of age and this rate may increase up to 14% in the population over 65 years of age. The annual incidence of Essential Tremor was found to be 616 per 100 thousand.
The incidence of the disease increases with age. An incidence study shows that the disease increases progressively with age, with a sharp increase after age 49. In another study, it was stated that the age of onset of the disease showed a bimodal distribution, reaching the highest level in the second and sixth decades. It is stated that the severity and disability of tremor increase with age. The female-to-male ratio of the disease was found to be equal, but it was shown that more head tremor developed in females.
Although the factors affecting essential tremor are aging, stress, family history, excessive caffeine consumption, smoking, muscle weakness, distal and proximal muscle strength differences were detected in young individuals with tremor. The aim of this study was to investigate the relationship between proximal and distal muscle strength and upper extremity functional skills in geriatric individuals with essential tremor.
Detailed description
In order for many elderly individuals to maintain their independence in functional activities, it is critical that the upper extremity dexterity is at a good level. Because the upper extremity needs to be functional in the realization of social relations such as writing, cooking, combing their hair, brushing their teeth, and participating in recreational activities. Due to the importance of maintaining functional independence in old age, many reviews have attempted to identify primary age-related neuromuscular changes that have an impact on the decreased function of most of the elderly. Age-related declines in function can be explained by increased motor unit firing rate variability of various central and peripheral nervous systems. It is thought to increase tremor in the altered synchronization between motor units in agonist and antagonist muscles, as well as impaired activation between agonist and antagonist muscles. Muscle strength differences in upper extremity functional skills were detected between proximal and distal muscle groups in young individuals with Essential Tremor. In a study investigating the effect of resistance exercise training on tremor in geriatrics, the changes in postural tremor with resistance training in healthy older adults were investigated. In this study; The frequency and severity of tremor of two different groups that received strength and coordination training were evaluated, and it was stated that there was a significant difference in the strength training group.
In this study, which is the only literature study in which strength training was applied to geriatric individuals with essential tremor, it was not specified on which muscle groups the strength training would be effective. In our study, determining the strength differences of the proximal and distal muscle groups of geriatric individuals with essential tremor will enable the creation of effective programs specific to the individual and muscle groups in the rehabilitation program.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group | – | Other: TestGeriatric individuals |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- geriatric individuals with and without tremor
Key inclusion criteria (2 listed)
- Voluntary geriatric individuals aged 60-85 years with and without tremor
- with a mini mental test score above 24,
Key exclusion criteria (4 listed)
- have diabetic neuropathy
- have undergone hand surgery
- upper and lower motor paralysis
- a history of hand fracture
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 |
|---|---|---|
| TestMeasurements | Other | One group |
Primary outcome
ahn-Tolosa-Marin Tremor Rating Scale
Time frame: At baseline
It is a widely used clinical assessment scale for tremor. The severity of tremor body parts is determined as 5 grades from 0 (absent) to 4 (severe)
Proximal muscle strength
Time frame: At baseline
Digital dynamometer was used to evaluate muscle strength.
Dİstal muscle strength
Time frame: At baseline
Jamar dynamometer was used to evaluate muscle strength.
Disability Arm Shoulder Hand
Time frame: At baseline
The DASH-T questionnaire is completed by the individual and consists of 3 parts: the functional/symptom (DASH-FS), the business model (DASH-W), and the sports-musicians model (DASH-SM). The person answers all questions according to a 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not able to do at all). A score between 0-100 is obtained from each section. The higher the score, the higher the disability.
Nine Holes Peg test
Time frame: At baseline
The test is performed with the patient in a sitting position. The patient is asked to line up the nine sticks inside the box on the table as quickly as possible into the holes of the other box, and remove them immediately after finishing. The test is started with the dominant hand, the time is measured with a stopwatch, and it is started when the hand touches the bars and ends when the last stick is placed in the box.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- 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.
Zekiye İpek Katırcı Kırmacı principal investigator
Kahramanmaras Sutcu Imam University
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 Essential Tremor, run by Kahramanmaras Sutcu Imam 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 2 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: finished, as of the sponsor's last update on 17 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ahn-Tolosa-Marin Tremor Rating Scale (time frame: At baseline). 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?
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 17 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.