Rheumatoid Arthritis (RA)NCT07141927
The Effects of Kinesiophobia and Proprioception on Disability and Function in Rheumatoid Hand
An observational study of Rheumatoid Arthritis (RA), run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
This is a cross-sectional study aimed at examining the effects of kinesiophobia and proprioception on disability and function in the rheumatoid hand, compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Measurements
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2023to 28 Jul 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteer patients receiving treatment and follow-up at the rheumatology outpatient clinic of a university hospital formed the study sample. The healthy control group included hospital staff and volunteer companions of these patients.
Who may be able to join
- Diagnosis of RA
- Volunteering
- Being between the ages of 18 and 65
- Being healthy.
- Being between 18-65 years old.
- Being a volunteer
Who cannot join
- The presence of another rheumatic disease or chronic illness that could affect function and cause disability.
- Pain, deformity, or other cooperation issues (such as severe mental, visual, or hearing impairments) that prevent participation in measurements.
- Sensory loss in the upper extremity, history of surgery, and injury in the last six months.
- Any diagnosis of chronic or acute illness.
- In the upper extremity, history of surgery injury in the last six months.
Trial locations and contacts
1 site in 1 country.
About this study
This is a cross-sectional study aimed at examining the effects of kinesiophobia and proprioception on disability and function in the rheumatoid hand, compared to healthy controls.
Read the detailed description
Rheumatoid arthritis (RA) is a fairly common chronic inflammatory disease. Up to 90% of wrist and finger joints are affected by RA. Thus, it is known that a decrease in performance-based function and disability occur in the hand. Kinesiophobia leads to avoidance behavior, especially in painful conditions. Kinesiophobia has been shown to be a significant mental factor leading to functional loss and disability in rheumatoid hand (RH). On the other hand, joint repositioning sense measurements, which show proprioceptive losses in the wrist and hand joints due to the effects of RA, have been demonstrated. However, as far as we know, the contributions of these mental and biological factors (kinesiophobia + proprioception) to the function and disability of RH have not been examined together.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Measurements
- Keywords
- Disability, Function, Joint reposition sense, Kinesiophobia, Rheumatoid hand, Muscle strength
- Medical subject headings
- Arthritis, Rheumatoid, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementsOther
First, the demographic characteristics of all participants were recorded. For those who met the inclusion criteria, primary and secondary outcome measurements were performed by the same physical therapist in a single session
| Study group | Role | What they receive |
|---|---|---|
| RA group | RA volunteers followed in the rheumatology outpatient clinic of a university hospital Receives: Other: Measurements | |
| Healthy controls | Hospital staff and volunteer companions of these RA patients Receives: Other: Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
The participant's fear-avoidance behavior toward physical activity was assessed using the Tampa Kinesiophobia Scale.
Measured: First day
Wrist-thumb proprioception
Joint position sense for wrist extension and thumb carpometacarpal flexion was assessed with goniometry. Joint position sense was measured by the ability to actively replicate a pre-determined target angle (30 degrees). During the measurement, the participant's evaluated joints was brought to the target angle and held in this position for three seconds. The participant was asked to hold this position in their memory, after which the joints will be passively returned to the starting position. Then, the participant was asked to actively move their hand to these pre-determined positions. The result was determined by the average deviation angle obtained from the measurements repeated at thirty-second intervals. These measurement were only taken with the dominant hand.
Measured: First day
Hand function
Hand function was evaluated with the Dellon Modifiye Moberg pickup test.
Measured: First day
Hand disability
Hand disability was evaluated with the Disabilities of the Arm, Shoulder, and Hand
Measured: First day
Secondary outcomes (4)
Demographic characteristics
Gender, age, employment and income status, smoking habits, and dominant hand information were recorded. Education below high school was categorized as low education. RA patients were also asked about the duration of their illness.
Measured: First day
Disease activity
RA disease activity was assessed using the DAS28- theDiseaseActivity Score 28
Measured: First day
Physical activity level
: Participants' physical activity levels were assessed using the International Physical Activity Questionnaire-Short Form. An IPAQ score of less than 600 metabolic equivalents (METs) was defined as low activity
Measured: First day
Isometric wrist extensor muscle strength measurement
Measurements were taken with the participant sitting upright, elbow close to the body and bent at 90 degrees, forearm supported on a surface in pronation, and the wrist-hand in space. Strength measurement was performed using the MAKE method with the wrist in 30 degrees of extension and a dynamometer placed on the back of the hand.. The average of three measurements taken one minute apart after a trial was recorded in kilograms. This measurement was only taken with the dominant hand.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start18 Apr 2023
- Primary completion28 Nov 2023
- Study completion28 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selvin BALKİ, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141927
- Sponsor's protocol ID
- SCU-FTR-SB-03
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Kinesiophobia and Proprioception on Disability and Function in Rheumatoid Hand
- ClinicalTrials.gov ID
- NCT07141927
- Acronym / sponsor ID
- SCU-FTR-SB-03
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Disability, Function, Joint reposition sense, Kinesiophobia, Rheumatoid hand, Muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Jul 2024 (actual)
- First posted
- 26 Aug 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.
This is a cross-sectional study aimed at examining the effects of kinesiophobia and proprioception on disability and function in the rheumatoid hand, compared to healthy controls.
Detailed description
Rheumatoid arthritis (RA) is a fairly common chronic inflammatory disease. Up to 90% of wrist and finger joints are affected by RA. Thus, it is known that a decrease in performance-based function and disability occur in the hand. Kinesiophobia leads to avoidance behavior, especially in painful conditions. Kinesiophobia has been shown to be a significant mental factor leading to functional loss and disability in rheumatoid hand (RH). On the other hand, joint repositioning sense measurements, which show proprioceptive losses in the wrist and hand joints due to the effects of RA, have been demonstrated. However, as far as we know, the contributions of these mental and biological factors (kinesiophobia + proprioception) to the function and disability of RH have not been examined together.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA group | – | Other: MeasurementsRA volunteers followed in the rheumatology outpatient clinic of a university hospital |
| Healthy controls | – | Other: MeasurementsHospital staff and volunteer companions of these RA patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer patients receiving treatment and follow-up at the rheumatology outpatient clinic of a university hospital formed the study sample. The healthy control group included hospital staff and volunteer companions of these patients.
Key inclusion criteria (6 listed)
- Diagnosis of RA
- Volunteering
- Being between the ages of 18 and 65
- Being healthy.
- Being between 18-65 years old.
Key exclusion criteria (5 listed)
- The presence of another rheumatic disease or chronic illness that could affect function and cause disability.
- Pain, deformity, or other cooperation issues (such as severe mental, visual, or hearing impairments) that prevent participation in measurements.
- Sensory loss in the upper extremity, history of surgery, and injury in the last six months.
- Any diagnosis of chronic or acute illness.
- In the upper extremity, history of surgery injury in the last six months.
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 |
|---|---|---|
| MeasurementsFirst, the demographic characteristics of all participants were recorded. For those who met the inclusion criteria, primary and secondary outcome measurements were performed by the same physical therapist in a single session | Other | Healthy controls, RA group |
Primary outcome
Kinesiophobia
Time frame: First day
The participant's fear-avoidance behavior toward physical activity was assessed using the Tampa Kinesiophobia Scale.
Wrist-thumb proprioception
Time frame: First day
Joint position sense for wrist extension and thumb carpometacarpal flexion was assessed with goniometry. Joint position sense was measured by the ability to actively replicate a pre-determined target angle (30 degrees). During the measurement, the participant's evaluated joints was brought to the target angle and held in this position for three seconds. The participant was asked to hold this position in their memory, after which the joints will be passively returned to the starting position. Then, the participant was asked to actively move their hand to these pre-determined positions. The result was determined by the average deviation angle obtained from the measurements repeated at thirty-second intervals. These measurement were only taken with the dominant hand.
Hand function
Time frame: First day
Hand function was evaluated with the Dellon Modifiye Moberg pickup test.
Hand disability
Time frame: First day
Hand disability was evaluated with the Disabilities of the Arm, Shoulder, and Hand
4 secondary outcomes
Demographic characteristics
Time frame: First day
Disease activity
Time frame: First day
Physical activity level
Time frame: First day
Isometric wrist extensor muscle strength measurement
Time frame: First day
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 26 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rheumatoid Arthritis (RA), run by Cumhuriyet 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 6 inclusion and 5 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 26 Aug 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?
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?
Kinesiophobia (time frame: First day). The study lists 4 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 26 Aug 2025.