Rheumatoid ArthritisNCT06297694
Clinical Interpretation and Cutoff Scores for ABILHAND Questionnaire in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 Jul 2024
- How long will I take part?
- 6 Months
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PAU Romatology clinic
Who may be able to join
- People between the ages of 20-65, who were diagnosed with RA according to ACR criteria by the PAU Rheumatology clinic and who volunteered to participate in the study, will be included.
Who cannot join
- Patients with RA who have a neurological disease that may affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident), a psychiatric disease that affects cooperation, heart failure and lung pathology that affect daily living activities, and those with other concurrent autoimmune and rheumatic diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University School of Physical Therapy and Rehabilitation
Denizli
About this study
Official title: Clinical Interpretation and Cutoff Scores for Manual Ability Measured by the ABILHAND Questionnaire in Individuals With Rheumatoid Arthritis
In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity Score (DAS 28)
It is used to evaluate disease activity in individuals with rheumatoid arthritis. DAS28 is a tool consisting of 28 tender joint count (range 0-28), 28 swollen joint count (range 0-28), ESR (erythrocyte sedimentation rate) and overall health assessment on a visual analogue scale (range 0-100). The level of disease activity is low It is interpreted as (DAS28 ≤3.2), medium (3.2< DAS28 ≤ 5.1) or high (DAS28 > 5.1).
Measured: Baseline
Nine hole peg test
It is a battery that aims to measure the loss of skills in the hand. This device is a device consisting of a square platform and a storage box. There are 9 holes in the square area (12.7x2cm) and 9 cylinders suitable for these holes. The diameter of the holes was 0.71 cm, the diameter of the cylinders was 0.64 cm, the length was 3.2 cm, the distance between the holes was 3.2 cm, the hole depth was 1.3 cm and the size of the storage box was 13x13 cm. What is requested from the patients is to quickly take the 9 cylinders from the storage box, place them in the holes, quickly remove them from the holes and place them in the storage box, without taking a break. Meanwhile, the time is measured in seconds with a stopwatch. Three separate measurements will be made for the right and left hand and the average will be taken.
Measured: Baseline
Hand grip strength
Grip strength in the dominant and non-dominant hand will be evaluated in 'kg' unit with a JAMAR (Sammons Preston, USA) hand dynamometer. Patients will be measured in a sitting position with the elbow flexed at 90° and the wrist in the mid-position with the thumb pointing up. The measurement will be made three times consecutively and the average value will be used. Values will be recorded in kilogram units.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- 156 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Cagla Balkisli, Pamukkale University
- Investigators
- Bilge Basakci Calik, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297694
- Sponsor's protocol ID
- PamukkaleU.
- Status last verified
- Jan 2025
- First submitted
- 1 Mar 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Interpretation and Cutoff Scores for Manual Ability Measured by the ABILHAND Questionnaire in Individuals With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06297694
- Acronym / sponsor ID
- PamukkaleU.
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 7 Mar 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.
In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PAU Romatology clinic
Key inclusion criteria (1 listed)
- People between the ages of 20-65, who were diagnosed with RA according to ACR criteria by the PAU Rheumatology clinic and who volunteered to participate in the study, will be included.
Key exclusion criteria (1 listed)
- Patients with RA who have a neurological disease that may affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident), a psychiatric disease that affects cooperation, heart failure and lung pathology that affect daily living activities, and those with other concurrent autoimmune and rheumatic diseases.
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
Disease Activity Score (DAS 28)
Time frame: Baseline
It is used to evaluate disease activity in individuals with rheumatoid arthritis. DAS28 is a tool consisting of 28 tender joint count (range 0-28), 28 swollen joint count (range 0-28), ESR (erythrocyte sedimentation rate) and overall health assessment on a visual analogue scale (range 0-100). The level of disease activity is low It is interpreted as (DAS28 ≤3.2), medium (3.2< DAS28 ≤ 5.1) or high (DAS28 > 5.1).
Nine hole peg test
Time frame: Baseline
It is a battery that aims to measure the loss of skills in the hand. This device is a device consisting of a square platform and a storage box. There are 9 holes in the square area (12.7x2cm) and 9 cylinders suitable for these holes. The diameter of the holes was 0.71 cm, the diameter of the cylinders was 0.64 cm, the length was 3.2 cm, the distance between the holes was 3.2 cm, the hole depth was 1.3 cm and the size of the storage box was 13x13 cm. What is requested from the patients is to quickly take the 9 cylinders from the storage box, place them in the holes, quickly remove them from the holes and place them in the storage box, without taking a break. Meanwhile, the time is measured in seconds with a stopwatch. Three separate measurements will be made for the right and left hand and the average will be taken.
Hand grip strength
Time frame: Baseline
Grip strength in the dominant and non-dominant hand will be evaluated in 'kg' unit with a JAMAR (Sammons Preston, USA) hand dynamometer. Patients will be measured in a sitting position with the elbow flexed at 90° and the wrist in the mid-position with the thumb pointing up. The measurement will be made three times consecutively and the average value will be used. Values will be recorded in kilogram units.
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 3 Feb 2025.
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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.
Bilge Basakci Calik study director
Pamukkale 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 Rheumatoid Arthritis, run by Pamukkale 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 1 inclusion and 1 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 3 Feb 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?
Disease Activity Score (DAS 28) (time frame: Baseline). The study lists 3 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 3 Feb 2025.