NCT07291492

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

December 5, 2025

Last Update Submit

March 9, 2026

Conditions

Keywords

Health LiteracyFunctional Outcomes

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    post-injury 12th week

Study Arms (1)

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

Other: Patients who were referred to the hand rehabilitation unit for hand or forearm injuries will be followed for 12 weeks

Interventions

Conventional hand therapy will be applied (edema and scar management, exercises) for 12 weeks.

Patients with hand and/or forearm injuries

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Aged 18-65 years
  • Voluntarily agreed to participate
  • Presented with hand and/or forearm injuries

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

NOT YET RECRUITING

Pamukkale University

Denizli, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 27765527BACKGROUND
  • 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.

    PMID: 30688895BACKGROUND
  • 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.

    PMID: 40347201BACKGROUND

Related Links

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

HANDE USTA OZDEMIR, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

January 15, 2026

Primary Completion

March 23, 2026

Study Completion

March 23, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations