- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07291492
Health Literacy Level and Functional Outcomes in Patients With Hand and Forearm Injuries
March 9, 2026 updated by: HANDE USTA, Pamukkale University
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
117
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: HANDE USTA OZDEMIR, PhD
- Phone Number: +902582965845
- Email: husta@pau.edu.tr
Study Locations
-
-
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Denizli, Turkey (Türkiye)
- Recruiting
- Pamukkale University
-
Contact:
- Hande Usta Ozdemir
- Phone Number: +902582964279
- Email: husta@pau.edu.tr
-
Denizli, Turkey (Türkiye), 20070
- Not yet recruiting
- Pamukkale University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- Aged 18-65 years
- Voluntarily agreed to participate
- Presented with hand and/or forearm injuries
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Conventional hand therapy will be applied (edema and scar management, exercises) for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
post-injury 12th week.
|
|
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
|
post-injury 12th week
|
|
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
|
post-injury 12th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Roy 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.
- Miclau 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2026
Primary Completion (Estimated)
March 23, 2026
Study Completion (Estimated)
March 23, 2026
Study Registration Dates
First Submitted
December 5, 2025
First Submitted That Met QC Criteria
December 5, 2025
First Posted (Actual)
December 18, 2025
Study Record Updates
Last Update Posted (Actual)
March 11, 2026
Last Update Submitted That Met QC Criteria
March 9, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-60116787-020-789611
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hand Injuries
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Poznan University of Medical SciencesCompletedWrist Injuries | Hand Injuries | Hand Injuries and Disorders | Hand Disease | Wrist DiseasePoland
-
McGill University Health Centre/Research Institute...CompletedAnesthesia, Local | Hand Injuries | Quality of Recovery | Hand Surgery | Hand Fracture | Hand Tendon InjuryCanada
-
Necmettin Erbakan UniversityKonya City HospitalRecruitingBurn Injuries | Hand Injuries | Hand BurnTurkey (Türkiye)
-
Istinye UniversityRecruitingTraumatic Hand InjuriesTurkey (Türkiye)
-
University of ZurichWithdrawnHand Osteoarthritis | Wrist Injuries | Wrist Fracture | Hand Injury Wrist | Wrist Arthritis | Hand Fracture | Hand Sprain
-
Hôpital du ValaisCompletedHand InjurySwitzerland
-
University of OxfordCompletedHand Injuries/Disease Requiring Surgery to the HandUnited Kingdom
-
Université de SherbrookeCompleted
-
Mayo ClinicCompletedInfection | Hand Injuries | Hand Injury Wrist | Hand Injuries and Disorders | Hand ArthritisUnited States
-
Chang Gung Memorial HospitalCompleted