Upper Extremity InjuriesNCT06715397
Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Adolfsson-Björnsson Upper Extremity Activity Scale (ABAS)
An observational study of Upper Extremity Injuries and Questionnaire and Survey, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Activity limitation is a common problem in individuals with upper extremity disorders. Many conditions involving the shoulder complex such as traumatic and non-traumatic upper extremity pain, subacromial impingement, postoperative pain, rotator sheath tears, rotator sheath tendinopathy, shoulder arthritis, adhesive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Extremity Injuries, Questionnaire and Survey, Reliability and Validity
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2025to 30 Dec 2026
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with upper extremity injuries who are able to read and write in Turkish and are aged 18 years and older will be included in the study. Only participants whose health status remains unchanged at the time of retesting will be included in the test-retest analysis. Patients with mental and neurological disorders (major depression, schizophrenia, psychosis, stroke, cerebral palsy, etc.) and/or rheumatological disease, active local or systemic infection, cancer history, severe visual impairment, need for emergency surgery, injection in the last 3 years, sensory problems that may affect the application of scales and cognitive impairment will be excluded from the study.
Who may be able to join
- -Patients with upper extremity injuries who are able to read and write in Turkish and are aged 18 years and older.
Who cannot join
- Mental and neurological disorders (major depression, schizophrenia, psychosis, stroke, cerebral palsy, etc.) and/or rheumatological disease, active local or systemic infection, cancer history, severe visual impairment, need for emergency surgery, injection in the last 3 years, sensory problems that may affect the application of scales and cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Adolfsson-Björnsson Upper Extremity Activity Scale (ABAS) in Individuals With Upper Extremity Injuries
Activity limitation is a common problem in individuals with upper extremity disorders. Many conditions involving the shoulder complex such as traumatic and non-traumatic upper extremity pain, subacromial impingement, postoperative pain, rotator sheath tears, rotator sheath tendinopathy, shoulder arthritis, adhesive capsulitis, shoulder instabilities may lead to limitations in activities of daily living due to pain and/or symptoms. Therefore, evaluation of upper extremity activities and determination of possible limitations have an important place in the management of the disease process.
Until now, symptom-related activities of daily living in patients with upper limb disorders have often been assessed with the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) and the Shoulder Pain and Disability Index (SPADI). However, in the development of these scales, only statements describing specific activities were used and items were not scored from easy to difficult according to activity level. There is no scale specifically developed for upper extremity pathologies that grades upper extremity activity level according to a certain level of difficulty. In order to fill this gap in the literature, Adolfsson et al. developed 'The Adolfsson-Björnsson Upper Extremity Activity Scale (ABAS)' to evaluate activities of daily living according to the perceived difficulty level in individuals with upper extremity injuries. Cross-cultural adaptation, validity and reliability of the Turkish version of the ABAS have not been studied.
The aim of this study was to make a cross-cultural Turkish adaptation of the 'The Adolfsson-Björnsson Upper Extremity Activity Scale (ABAS)' and to investigate the validity, reliability and psychometric properties of the Turkish version on individuals with upper extremity disorders.
Read the detailed description
The research will be conducted according to the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines.
Translation and cross-cultural adaptation of the ABAS will be carried out in five stages according to standard guidelines for scale translation and cross-cultural adaptation. It was planned to include a minimum of 90 individuals aged 18 years and older with upper extremity disorders in the study.
The data collection for this planned study will be solely through surveys. The design of the study is a cross-sectional study aimed at developing and assessing the validity and reliability." Surveys specific to the research will be implemented in the study.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with upper limb injuries | Patients with upper extremity injuries who are able to read and write in Turkish and are aged 18 years and older will be included in the study. Only participants whose health status remains unchanged at the time of retesting will be included in the test-retest analysis.
Patients with mental and neurological disorders (major depression, schizophrenia, psychosis, stroke, cerebral palsy, etc.) and/or rheumatological disease, active local or systemic infection, cancer history, severe visual impairment, need for emergency surgery, injection in the last 3 years, sensory problems that may affect the application of scales and cognitive impairment will be excluded from the study. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigating Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of The Adolfsson-Björnsson Activity Scale (ABAS) with upper ekstremity injuries
The scale items consist of 8 different categories. The increase in the mean of the questionnaire from category 1 to 8 indicates that the upper extremity is used in higher level activities.
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 posted4 Dec 2024
- Study start29 Dec 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity InjuriesStudies 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
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Hande Esen, Mustafa Kemal University
- Investigators
- Dilek Hande Esen, PhD, Principal investigator, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715397
- Sponsor's protocol ID
- E-77082166-604.01.02-809466
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hazar Kanik Z, Pala OO, Karabicak GO, Citaker S. Cross-cultural adaptation, validity, and reliability of the Turkish version of the Patient-Rated Elbow Evaluation. Clin Rheumatol. 2019 Nov;38(11):3289-3295. doi: 10.1007/s10067-019-04665-4. Epub 2019 Jul 6.
PubMed 31280380Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514.
PubMed 4048757Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Adolfsson-Björnsson Upper Extremity Activity Scale (ABAS) in Individuals With Upper Extremity Injuries
- ClinicalTrials.gov ID
- NCT06715397
- Acronym / sponsor ID
- E-77082166-604.01.02-809466
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Dec 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.
Activity limitation is a common problem in individuals with upper extremity disorders. Many conditions involving the shoulder complex such as traumatic and non-traumatic upper extremity pain, subacromial impingement, postoperative pain, rotator sheath tears, rotator sheath tendinopathy, shoulder arthritis, adhesive capsulitis, shoulder instabilities may lead to limitations in activities of daily living due to pain and/or symptoms. Therefore, evaluation of upper extremity activities and determination of possible limitations have an important place in the management of the disease process.
Until now, symptom-related activities of daily living in patients with upper limb disorders have often been assessed with the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) and the Shoulder Pain and Disability Index (SPADI). However, in the development of these scales, only statements describing specific activities were used and items were not scored from easy to difficult according to activity level. There is no scale specifically developed for upper extremity pathologies that grades upper extremity activity level according to a certain level of difficulty. In order to fill this gap in the literature, Adolfsson et al. developed 'The Adolfsson-Björnsson Upper Extremity Activity Scale (ABAS)' to evaluate activities of daily living according to the perceived difficulty level in individuals with upper extremity injuries. Cross-cultural adaptation, validity and reliability of the Turkish version of the ABAS have not been studied.
The aim of this study was to make a cross-cultural Turkish adaptation of the 'The Adolfsson-Björnsson Upper Extremity Activity Scale (ABAS)' and to investigate the validity, reliability and psychometric properties of the Turkish version on individuals with upper extremity disorders.
Detailed description
The research will be conducted according to the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines.
Translation and cross-cultural adaptation of the ABAS will be carried out in five stages according to standard guidelines for scale translation and cross-cultural adaptation. It was planned to include a minimum of 90 individuals aged 18 years and older with upper extremity disorders in the study.
The data collection for this planned study will be solely through surveys. The design of the study is a cross-sectional study aimed at developing and assessing the validity and reliability." Surveys specific to the research will be implemented in the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with upper limb injuries | – | Other: No interventionPatients with upper extremity injuries who are able to read and write in Turkish and are aged 18 years and older will be included in the study. Only participants whose health status remains unchanged at the time of retesting will be included in the test-retest analysis. Patients with mental and neurological disorders (major depression, schizophrenia, psychosis, stroke, cerebral palsy, etc.) and/or rheumatological disease, active local or systemic infection, cancer history, severe visual impairment, need for emergency surgery, injection in the last 3 years, sensory problems that may affect the application of scales and cognitive impairment will be excluded from the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with upper extremity injuries who are able to read and write in Turkish and are aged 18 years and older will be included in the study. Only participants whose health status remains unchanged at the time of retesting will be included in the test-retest analysis. Patients with mental and neurological disorders (major depression, schizophrenia, psychosis, stroke, cerebral palsy, etc.) and/or rheumatological disease, active local or systemic infection, cancer history, severe visual impairment, need for emergency surgery, injection in the last 3 years, sensory problems that may affect the application of scales and cognitive impairment will be excluded from the study.
Key inclusion criteria (1 listed)
- -Patients with upper extremity injuries who are able to read and write in Turkish and are aged 18 years and older.
Key exclusion criteria (1 listed)
- Mental and neurological disorders (major depression, schizophrenia, psychosis, stroke, cerebral palsy, etc.) and/or rheumatological disease, active local or systemic infection, cancer history, severe visual impairment, need for emergency surgery, injection in the last 3 years, sensory problems that may affect the application of scales and cognitive impairment
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 |
|---|---|---|
| No interventionNo intervention | Other | Patients with upper limb injuries |
Primary outcome
Investigating Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of The Adolfsson-Björnsson Activity Scale (ABAS) with upper ekstremity injuries
Time frame: 1 weeks
The scale items consist of 8 different categories. The increase in the mean of the questionnaire from category 1 to 8 indicates that the upper extremity is used in higher level activities.
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 11 Aug 2026.
- Results publication: PubMed 31280380Hazar Kanik Z, Pala OO, Karabicak GO, Citaker S. Cross-cultural adaptation, validity, and reliability of the Turkish version of the Patient-Rated Elbow Evaluation. Clin Rheumatol. 2019 Nov;38(11):3289-3295. doi: 10.1007/s10067-019-04665-4. Epub 2019 Jul 6.
- Results publication: PubMed 4048757Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514.
- Results publication: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
- 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.
Dilek Hande Esen, PhD principal investigator
Toros 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 Upper Extremity Injuries and Questionnaire and Survey, run by Mustafa Kemal 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. 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?
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?
Investigating Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of The Adolfsson-Björnsson Activity Scale (ABAS) with upper ekstremity injuries (time frame: 1 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06715397, which also lists 3 linked publications.
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 11 Aug 2026.