Hand InjuriesNCT07291492
Health Literacy Level and Functional Outcomes in Patients With Hand and Forearm Injuries
An observational study of Hand Injuries and Forearm Fractures, run by Pamukkale University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the association between health literacy, patient-reported outcome measures, and grip strength in a cohort of patients with hand injuries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hand Injuries, Forearm Fractures
- What is being tested?
- Patients who were referred to the hand rehabilitation unit for hand or forearm injuries will be followed for 12 weeks
- How many people
- 117 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 23 Mar 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were referred to the hand rehabilitation unit for hand or forearm injuries, aged 18-65 years who voluntarily agreed to participate will be included to the study
Who may be able to join
- Aged 18-65 years
- Voluntarily agreed to participate
- Presented with hand and/or forearm injuries
Who cannot join
- Concomitant shoulder or elbow injuries
- History of surgery due to neurological, rheumatological, or metabolic conditions affecting the entire upper extremity
- Employment in a health-related profession
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Pamukkale University
Denizli, 20070
- Recruiting
Pamukkale University
Denizli
Hande Usta Ozdemir, +902582964279, husta@pau.edu.tr
About this study
Official title: Examining the Relationship Between Health Literacy Level and Functional Outcomes in Patients With Hand and Forearm Injuries
The aim of this study is to examine the association between health literacy, patient-reported outcome measures, and grip strength in a cohort of patients with hand injuries.
- Conditions
- Hand Injuries, Forearm Fractures
- Being tested
- Patients who were referred to the hand rehabilitation unit for hand or forearm injuries will be followed for 12 weeks
- Keywords
- Health Literacy, Functional Outcomes
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients who were referred to the hand rehabilitation unit for hand or forearm injuries will be followed for 12 weeksOther
Conventional hand therapy will be applied (edema and scar management, exercises) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hand and/or forearm injuries | Patients aged 18-65 years who voluntarily agreed to participate and who presented with hand and/or forearm injuries Receives: Other: Patients who were referred to the hand rehabilitation unit for hand or forearm injuries will be followed for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Health Literacy Scale
The scale is based on a conceptual framework comprising three health-related domains (treatment, disease prevention, and health promotion) as well as four information-processing stages (accessing, understanding, appraising/decision-making, and applying health information). The instrument contains 47 items rated on a four-point Likert scale.The total score is standardized to range from 0 to 50. Health literacy levels are categorized as follows: (0-25): insufficient, (>25-33): problematic-limited, (>33-42): sufficient, (>42-50): excellent
Measured: post-injury 12th week.
Michigan Hand Outcomes Questionnaire
The MHOQ assesses hand and wrist status across six domains: function, activities of daily living, work performance, pain, aesthetics, and patient satisfaction. It consists of 63 items addressing both hands. Each item is scored on a 1-5 scale, and each domain score is converted to a 0-100 scale. Except for the pain domain, higher scores indicate better outcomes
Measured: post-injury 12th week
Grip strength
Grip strength was assessed according to the procedure recommended by the American Society of Hand Therapists. A Jamar dynamometer was used to evaluate gross grip strength. Measurements were performed with the patient seated without elbow support, the arm in adduction and neutral rotation, the elbow flexed at 90°, the forearm in a neutral position, and the wrist positioned in approximately 30° extension. Beginning with the dominant hand, measurements were taken on both sides. The mean value of three trials was recorded
Measured: post-injury 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start15 Jan 2026
- Primary completion23 Mar 2026 (estimated)
- Study completion23 Mar 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 Hand InjuriesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE USTA, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291492
- Sponsor's protocol ID
- E-60116787-020-789611
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We may share de-identified IPD upon reasonable request and subject to appropriate data-use agreements, provided that sharing aligns with participant consent and institutional policies.
Publications
Roh YH, Lee BK, Park MH, Noh JH, Gong HS, Baek GH. Effects of health literacy on treatment outcome and satisfaction in patients with mallet finger injury. J Hand Ther. 2016 Oct-Dec;29(4):459-464. doi: 10.1016/j.jht.2016.06.004. Epub 2016 Oct 17.
PubMed 27765527Roy M, Okrainec K, Novak CB, von Schroeder HP, Urbach DR, McCabe SJ. Universal Measures of Support Are Needed: A Cross-Sectional Study of Health Literacy in Patients with Dupuytren's Disease. Plast Reconstr Surg. 2019 Feb;143(2):350e-358e. doi: 10.1097/PRS.0000000000005209.
PubMed 30688895Miclau KR, Kwong JW, Tapp E, Mulakaluri A; sALLud Consortium; Shapiro LM. Evaluating the Association Between Health Literacy and Patient-Reported Outcome Measures After Distal Radius Fracture. J Hand Surg Am. 2026 Feb;51(2):173.e1-173.e10. doi: 10.1016/j.jhsa.2025.03.022. Epub 2025 May 9.
PubMed 40347201
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Relationship Between Health Literacy Level and Functional Outcomes in Patients With Hand and Forearm Injuries
- ClinicalTrials.gov ID
- NCT07291492
- Acronym / sponsor ID
- E-60116787-020-789611
- Conditions
- Hand Injuries, Forearm Fractures
- Keywords
- Health Literacy, Functional Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 23 Mar 2026 (estimated)
- Study completion
- 23 Mar 2026 (estimated)
- First posted
- 18 Dec 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.
The aim of this study is to examine the association between health literacy, patient-reported outcome measures, and grip strength in a cohort of patients with hand injuries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hand and/or forearm injuries | – | Other: Patients who were referred to the hand rehabilitation unit for hand or forearm injuries will be followed for 12 weeksPatients aged 18-65 years who voluntarily agreed to participate and who presented with hand and/or forearm injuries |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were referred to the hand rehabilitation unit for hand or forearm injuries, aged 18-65 years who voluntarily agreed to participate will be included to the study
Key inclusion criteria (3 listed)
- Aged 18-65 years
- Voluntarily agreed to participate
- Presented with hand and/or forearm injuries
Key exclusion criteria (3 listed)
- Concomitant shoulder or elbow injuries
- History of surgery due to neurological, rheumatological, or metabolic conditions affecting the entire upper extremity
- Employment in a health-related profession
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 |
|---|---|---|
| Patients who were referred to the hand rehabilitation unit for hand or forearm injuries will be followed for 12 weeksConventional hand therapy will be applied (edema and scar management, exercises) for 12 weeks. | Other | Patients with hand and/or forearm injuries |
Primary outcome
European Health Literacy Scale
Time frame: post-injury 12th week.
The scale is based on a conceptual framework comprising three health-related domains (treatment, disease prevention, and health promotion) as well as four information-processing stages (accessing, understanding, appraising/decision-making, and applying health information). The instrument contains 47 items rated on a four-point Likert scale.The total score is standardized to range from 0 to 50. Health literacy levels are categorized as follows: (0-25): insufficient, (>25-33): problematic-limited, (>33-42): sufficient, (>42-50): excellent
Michigan Hand Outcomes Questionnaire
Time frame: post-injury 12th week
The MHOQ assesses hand and wrist status across six domains: function, activities of daily living, work performance, pain, aesthetics, and patient satisfaction. It consists of 63 items addressing both hands. Each item is scored on a 1-5 scale, and each domain score is converted to a 0-100 scale. Except for the pain domain, higher scores indicate better outcomes
Grip strength
Time frame: post-injury 12th week
Grip strength was assessed according to the procedure recommended by the American Society of Hand Therapists. A Jamar dynamometer was used to evaluate gross grip strength. Measurements were performed with the patient seated without elbow support, the arm in adduction and neutral rotation, the elbow flexed at 90°, the forearm in a neutral position, and the wrist positioned in approximately 30° extension. Beginning with the dominant hand, measurements were taken on both sides. The mean value of three trials was recorded
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 Mar 2026.
- Background: PubMed 27765527Roh YH, Lee BK, Park MH, Noh JH, Gong HS, Baek GH. Effects of health literacy on treatment outcome and satisfaction in patients with mallet finger injury. J Hand Ther. 2016 Oct-Dec;29(4):459-464. doi: 10.1016/j.jht.2016.06.004. Epub 2016 Oct 17.
- Background: PubMed 30688895Roy M, Okrainec K, Novak CB, von Schroeder HP, Urbach DR, McCabe SJ. Universal Measures of Support Are Needed: A Cross-Sectional Study of Health Literacy in Patients with Dupuytren's Disease. Plast Reconstr Surg. 2019 Feb;143(2):350e-358e. doi: 10.1097/PRS.0000000000005209.
- Background: PubMed 40347201Miclau KR, Kwong JW, Tapp E, Mulakaluri A; sALLud Consortium; Shapiro LM. Evaluating the Association Between Health Literacy and Patient-Reported Outcome Measures After Distal Radius Fracture. J Hand Surg Am. 2026 Feb;51(2):173.e1-173.e10. doi: 10.1016/j.jhsa.2025.03.022. Epub 2025 May 9.
- World Health Organization (WHO). (2016). Health literacy: The solid facts.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We may share de-identified IPD upon reasonable request and subject to appropriate data-use agreements, provided that sharing aligns with participant consent and institutional policies.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Injuries and Forearm Fractures, run by Pamukkale University at 2 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact HANDE USTA OZDEMIR, PhD (+902582965845, husta@pau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Health Literacy Scale (time frame: post-injury 12th week.). 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?
On the ClinicalTrials.gov record for NCT07291492, 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 Mar 2026.