NCT07329400

Brief Summary

The goal of this observational study is to evaluate the validity and reliability of the Turkish adaptation of the Burnt Hand Outcome Tool (BHOT) in adults with a history of hand burns. The participant population will include adults aged 18 years and older who have experienced unilateral or bilateral hand burns and can read and understand Turkish.The main questions this study aims to answer are: Does the Turkish version of the BHOT demonstrate high internal consistency, test-retest reliability, and construct validity? How strongly are BHOT scores associated with objective hand function measures such as grip strength and sensory evaluation? Participants will not be assigned to comparison groups, as this is a methodological validation study. Participants will: Complete a sociodemographic information form. Complete the Turkish version of the BHOT and the QuickDASH questionnaire. Undergo objective assessments including hand grip strength using a dynamometer and sensory evaluation using Semmes-Weinstein monofilaments. Participate in repeated assessments at baseline, 1 month, 3 months and 6 months for reliability analyses.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Nov 2025Nov 2026

Study Start

First participant enrolled

November 17, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

November 29, 2025

Last Update Submit

January 11, 2026

Conditions

Keywords

Hand BurnsBurnt Hand Outcome Tool (BHOT)Validation StudyReproducibility of ResultsBurn Injuries

Outcome Measures

Primary Outcomes (2)

  • Reliability of the Turkish Version of the Burnt Hand Outcome Tool (BHOT)

    Total score of the Turkish version of the Burnt Hand Outcome Tool (BHOT-T), a patient-reported outcome measure assessing functional, aesthetic, sensory, and psychosocial outcomes in adults with hand burns. The BHOT-T consists of 20 items, each scored on a Likert scale. Total scores range from 0 to 80, with higher scores indicating worse outcomes / greater negative impact of hand burns on hand function and quality of life.

    Baseline , 1 month, 3 months, and 6 months

  • Construct Validity of Burnt Hand Outcome Tool-Turkish

    Construct validity will be assessed using confirmatory factor analysis (CFA) to evaluate the factor structure of the Turkish version of Burnt Hand Outcome Tool.

    baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (4)

  • Convergent Validity With QuickDASH

    Baseline, 1 month, 3 months, and 6 months

  • Hand Grip Strength

    Baseline

  • Sensory Function Assessment

    Baseline

  • Discriminant Validity by Clinical Characteristics

    Baseline

Interventions

Assessment using the Turkish version of the Burnt Hand Outcome Tool (BHOT) for validity and reliability evaluation; no treatment is applied.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18 years and older with a history of second-degree or higher burn injury in one or both hands who are receiving outpatient or inpatient care at the burn unit. All participants are able to read and understand Turkish and provide informed consent.

You may qualify if:

  • Age 18 years or older
  • History of second-degree or higher burn injury in one or both hands
  • Ability to read and understand Turkish
  • Willingness to participate and provision of written informed consent

You may not qualify if:

  • History of trauma, surgery, or rheumatologic disease affecting hand function prior to the burn injury
  • Age under 18 years
  • Cognitive impairment or psychiatric disorder preventing completion of the questionnaires
  • Refusal to participate or withdrawal from the study at any time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital (Konya Şehir Hastanesi)

Konya, Meram, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hand InjuriesBurns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Pariya Puriyamanesh

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc student in Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

November 29, 2025

First Posted

January 9, 2026

Study Start

November 17, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations