DiseaseNCT06857526
The Relationship of Hand Sensory and Strength Assessments with Functionality and Kinesiophobia in Individuals with Rheumatoid Arthritis
An observational study of Disease, run by Firat University.
Trial summary
Rheumatoid arthritis (RA) is a systemic inflammatory disease that can involve all tissues with synovium. The wrist and hand, which are of great importance in our daily activities, are involved early and specifically because they are rich in synovium, which is the target tissue in RA.In many patients with rheumatoid… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disease
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2025to 5 Jun 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with rheumatoid arthritis
Who may be able to join
- Female patients between 18-65 years of age
- Patients whose medical treatment has been stable for the last 3 months
Who cannot join
- Patients who have undergone surgery on the hand and wrist
- Patients with prosthesis
- Patients with neurological or orthopedic diseases
- Patients with another accompanying rheumatic disease
- Patients with malignancy
- Pregnant patients
About this study
Rheumatoid arthritis (RA) is a systemic inflammatory disease that can involve all tissues with synovium. The wrist and hand, which are of great importance in our daily activities, are involved early and specifically because they are rich in synovium, which is the target tissue in RA.In many patients with rheumatoid arthritis, hand and wrist involvement is seen from the early stages of the disease. Pain, stiffness and swelling in the joint are accompanied by decreased range of motion and muscle strength.Hand functions have a very important place due to the fact that the hand must be used in countless daily life activities.Kinesiophobia is defined as a state of fear and avoidance of activity and physical movement caused by painful injury and sensitivity to repeated injury.The aim of this study was to investigate the relationship between hand sensory and strength assessment, functionality and kinesiophobia in individuals with rheumatoid arthritis.
Read the detailed description
Rheumatoid arthritis (RA) is a systemic inflammatory disease that can involve all tissues with synovium. The wrist and hand, which are of great importance in our daily activities, are involved early and specifically because they are rich in synovium, which is the target tissue in RA.In many patients with rheumatoid arthritis, hand and wrist involvement is seen from the early stages of the disease. Pain, stiffness and swelling in the joint are accompanied by decreased range of motion and muscle strength.Hand functions have a very important place due to the fact that the hand must be used in countless daily life activities.Kinesiophobia is defined as a state of fear and avoidance of activity and physical movement caused by painful injury and sensitivity to repeated injury.The aim of this study was to investigate the relationship between hand sensory and strength assessment, functionality and kinesiophobia in individuals with rheumatoid arthritis.Thirty patients who were followed up in the Rheumatology outpatient clinic of Fırat University Hospital and diagnosed with RA according to the American College of Rheumatology (ACR) criteria will be included. SPSS program will be used in statistical analysis. Descriptive statistics will be used for the demographic characteristics of the groups. Qualitative variables will be defined by number and quantitative variables will be defined by mean and standard deviation.
- Conditions
- Disease
- Keywords
- hand force assessment, hand sensory evaluation, romatoid artrit
- Medical subject headings
- 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 |
|---|---|---|
| Romatoid artrit | Patient diagnosed with RA according to the American College of Rheumatology (ACR) criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand sensory evaluation
Semmes-Weinstein Monofilaments will be used to measure light touch sensation.This test is performed with the patient's head turned to the other side.The monofilaments are held perpendicular to the skin and pressed against the skin until there is a slight curvature. The test is performed 3 times for monofilaments from 1.65 to 4.08 to obtain a stimulus response. 1 time for monofilaments from 4.17 to 6.65. If the patient hidded this monofilament, the test is finished. If the patient does not respond to the stimulus, the test is switched to the thicker filament and continued until the patient feels it.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start5 Mar 2025 (estimated)
- Primary completion25 May 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857526
- Sponsor's protocol ID
- FiratU-FTR
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 4 Mar 2025
- 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 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Hand Sensory and Strength Assessments with Functionality and Kinesiophobia in Individuals with Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06857526
- Acronym / sponsor ID
- FiratU-FTR
- Conditions
- Disease
- Keywords
- hand force assessment, hand sensory evaluation, romatoid artrit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (estimated)
- Primary completion
- 25 May 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 4 Mar 2025 (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.
Rheumatoid arthritis (RA) is a systemic inflammatory disease that can involve all tissues with synovium. The wrist and hand, which are of great importance in our daily activities, are involved early and specifically because they are rich in synovium, which is the target tissue in RA.In many patients with rheumatoid arthritis, hand and wrist involvement is seen from the early stages of the disease. Pain, stiffness and swelling in the joint are accompanied by decreased range of motion and muscle strength.Hand functions have a very important place due to the fact that the hand must be used in countless daily life activities.Kinesiophobia is defined as a state of fear and avoidance of activity and physical movement caused by painful injury and sensitivity to repeated injury.The aim of this study was to investigate the relationship between hand sensory and strength assessment, functionality and kinesiophobia in individuals with rheumatoid arthritis.
Detailed description
Rheumatoid arthritis (RA) is a systemic inflammatory disease that can involve all tissues with synovium. The wrist and hand, which are of great importance in our daily activities, are involved early and specifically because they are rich in synovium, which is the target tissue in RA.In many patients with rheumatoid arthritis, hand and wrist involvement is seen from the early stages of the disease. Pain, stiffness and swelling in the joint are accompanied by decreased range of motion and muscle strength.Hand functions have a very important place due to the fact that the hand must be used in countless daily life activities.Kinesiophobia is defined as a state of fear and avoidance of activity and physical movement caused by painful injury and sensitivity to repeated injury.The aim of this study was to investigate the relationship between hand sensory and strength assessment, functionality and kinesiophobia in individuals with rheumatoid arthritis.Thirty patients who were followed up in the Rheumatology outpatient clinic of Fırat University Hospital and diagnosed with RA according to the American College of Rheumatology (ACR) criteria will be included. SPSS program will be used in statistical analysis. Descriptive statistics will be used for the demographic characteristics of the groups. Qualitative variables will be defined by number and quantitative variables will be defined by mean and standard deviation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Romatoid artrit | – | –Patient diagnosed with RA according to the American College of Rheumatology (ACR) criteria |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with rheumatoid arthritis
Key inclusion criteria (2 listed)
- Female patients between 18-65 years of age
- Patients whose medical treatment has been stable for the last 3 months
Key exclusion criteria (6 listed)
- Patients who have undergone surgery on the hand and wrist
- Patients with prosthesis
- Patients with neurological or orthopedic diseases
- Patients with another accompanying rheumatic disease
- Patients with malignancy
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
hand sensory evaluation
Time frame: 15 minutes
Semmes-Weinstein Monofilaments will be used to measure light touch sensation.This test is performed with the patient's head turned to the other side.The monofilaments are held perpendicular to the skin and pressed against the skin until there is a slight curvature. The test is performed 3 times for monofilaments from 1.65 to 4.08 to obtain a stimulus response. 1 time for monofilaments from 4.17 to 6.65. If the patient hidded this monofilament, the test is finished. If the patient does not respond to the stimulus, the test is switched to the thicker filament and continued until the patient feels it.
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 4 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease, run by Firat University.
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 6 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: opening soon, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
hand sensory evaluation (time frame: 15 minutes). 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 4 Mar 2025.