NCT07614971

Brief Summary

The purpose of the study will to test the:

  • Face validity of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
  • Content validity of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
  • Concurrent validity of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
  • Feasibility of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
  • Internal consistency reliability of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
  • Test- retest reliability of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.

Trial Health

63
Monitor

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
4mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress44%
May 2026Dec 2026

Study Start

First participant enrolled

May 1, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 22, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

BurnHand functionMichigan Hand Outcomes QuestionnaireValidityReliability

Outcome Measures

Primary Outcomes (6)

  • Face validity of Arabic version of Michigan Hand Questionnaire

    Ten experts test the scale for clarity of instruction, items and response format (face validity) and to provide suggestions to improve its clarity using dichotomous question (clear -unclear).

    6 months

  • Content validity of Arabic version of Michigan Hand Questionnaire

    The extent to which a research instrument accurately measures all aspects of a construct.

    6 months

  • Concurrent validity of Arabic version of Michigan Hand Questionnaire

    It s the degree to which the results or scores on a test are related to the scores on another, already established, test administered at the same time, or to some other valid criterion available at the same time.

    6 months

  • Feasibility of Arabic version of Michigan Hand Questionnaire

    The medical committee agreed to judge feasibility using two factors (time and missing items) regarding translated instruments. the percent of missing items shouldn't be higher than 20 %.

    6 months

  • Internal consistency reliability of Arabic version of Michigan Hand Questionnaire

    The items within the scale reflect or measure the same concept. This means that the items within the scale correlate or are complementary to each other, assessed by using Cronbach's alpha.

    6 months

  • Test-Retest Reliability of Arabic version of Michigan Hand Questionnaire

    The reliability coefficient obtained by repetition of the same measure on a second time is called the test-retest reliability. When a questionnaire containing some items that are supposed to measure a concept is administered to a set of respondents now, and after some time ranging from few days to weeks or months, again administered on the same respondents. The correlation coefficient calculated between two set of data and if it is found to be high, better the test-retest reliability.

    6 months

Study Arms (1)

Post-burn patient

This study will be conducted on one hundred patients, aged from (20-35) years who suffered from second degree thermal burn injury with total body surface area (TBSA) for burn ranged from (20 -30%) with the burn injury involving the dorsal surface of the dominant hand. They will participate in the current study 1 month after burn injury.

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will include hundred Egyptian patients suffering from second degree thermal burn involving the dorsal surface of the dominant hand with total body surface area (TBSA) for burns ranged from 20% to 30%. They will be selected randomly from Assuit University Hospital and Otiefy Hospital, Assuit, Egypt.

You may qualify if:

  • Both genders are participated in this study.
  • All patients suffering from second degree thermal burn injury involving the dorsal surface of the dominant hand with TBSA ranged from 20% to30%.
  • All patients will be asked to fill the questionnaire after 1 month from burn injury and they will be asked to refill the questionnaire after 1 week.
  • All participants can read and write in Arabic.
  • All participants can understand items of the questionnaire easily.
  • All patients enrolled to the study had their informed consent

You may not qualify if:

  • Patients with cognitive and psychiatric disorders.
  • Patients with palmar and circumferential hand burn.
  • Patients with communication, vision and hearing disorders.
  • Patient who don't fill the questionnaire till the end.
  • Patient who aren't cooperative in filling the questionnaire.
  • Suicidal burn.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sawsan Monazae Abd El-Fattah

Asyut, Egypt

Location

Related Publications (3)

  • Corrales-Benitez C, Gonzalez-Peinado D, Gonzalez-Miranda A, Martinez-Mendez JR. Evaluation of burned hand function after enzymatic debridement. J Plast Reconstr Aesthet Surg. 2022 Mar;75(3):1048-1056. doi: 10.1016/j.bjps.2021.09.074. Epub 2021 Oct 22.

    PMID: 34848129BACKGROUND
  • Martinez-Fernandez MV, Sarabia-Cobo CM, Sanchez-Labraca N. Cross-cultural adaptation, reliability, validity and responsiveness of the Michigan Hand Outcomes Questionnaire (MHQ-Sp) in Spain. J Orthop Surg Res. 2024 Apr 22;19(1):256. doi: 10.1186/s13018-024-04723-x.

    PMID: 38649996BACKGROUND
  • Oksuz C, Akel BS, Oskay D, Leblebicioglu G, Hayran KM. Cross-cultural adaptation, validation, and reliability process of the Michigan Hand Outcomes Questionnaire in a Turkish population. J Hand Surg Am. 2011 Mar;36(3):486-92. doi: 10.1016/j.jhsa.2010.11.016. Epub 2011 Feb 4.

    PMID: 21295925BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Ayman Ahmed, Professor

    Cairo University

    STUDY DIRECTOR
  • Nesreen Abdel-Rashed

    Cairo University

    STUDY CHAIR

Central Study Contacts

Sawsan Abdel-Fattah, Master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Locations