Psychometric Measurement Properties of the Michigan Hand Questionnaire in Patients After Flexor Tendon Repair

June 8, 2023 updated by: University Hospital Inselspital, Berne

Psychometric Measurement Properties of the German Version of the Michigan Hand Questionnaire in Patients After Flexor Tendon Repair

The aim of the study is to investigate the psychometric properties of the German Version of the Michigan Hand Questionnaire in patients with flexor tendon injuries, including reliability, validity and interpretability.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

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

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with flexor tendon injuries in Zone I-V for in the fingers and/or thumb.

Description

Inclusion Criteria:

  • Informed consent as documented by signature
  • ≥ 18 years old
  • Understanding of the German language (written and oral)
  • Single and multiple finger injuries
  • Primary flexor tendon injuries in Zone I-V for the fingers and/ or thumb
  • Treated by the hand surgery department at the Inselspital Bern
  • Treated with at least a 4-strand core suture

Exclusion Criteria:

  • < 18 years old
  • Inability to follow the procedures of the study, e.g. due to language problems, diagnosed psychological disorders or dementia of the patients
  • Replantation of the injured finger
  • Fracture of the injured finger
  • Primary tendon reconstructions

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Michigan Hand Questionnaire (MHQ)
Time Frame: 6, 13, 13 1/2 and 26 weeks after tendon repair
The MHQ is a hand specific questionnaire used to measure the ability in daily function. The total score ranges from 0 to 100, with higher scores indicating better performance.
6, 13, 13 1/2 and 26 weeks after tendon repair

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of Shoulder, Arm and Hand Questionnaire
Time Frame: 6, 13 and 26 weeks after tendon repair]
The DASH questionnaire is a region-specific outcome instrument. The patient will rate 30-items about disability or symptoms by rating the degree of difficulty in doing various activities. The scores of all items are used to calculate a score ranging from 0 (no disability) to 100 (most severe disability). The DASH is a region-specific outcome instrument. The patient will rate 30-items about disability or symptoms by rating the degree of difficulty in doing various activities. The scores of all items are used to calculate a score ranging from 0 (no disability) to 100 (most severe disability).
6, 13 and 26 weeks after tendon repair]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Bernadette Tobler, Dr. phil., Inselspital, Bern University Hospital

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)

December 1, 2021

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-00929a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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