Study Stopped
same study was published from another group
Italian Translation of the Michigan Hand Outcomes Questionnaire
Italian Translation and Cross-cultural Adaptation of the Michigan Hand Outcomes Questionnaire
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. Some of the most used Questionnaires, unfortunately, are not available in Italian.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2021
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
August 22, 2020
CompletedFirst Posted
Study publicly available on registry
August 26, 2020
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2021
CompletedJanuary 3, 2022
December 1, 2021
9 days
August 22, 2020
December 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Validity
Validity will be assessed as structural validity, i.e., "the degree to which the scores of the Health-Related Patient Reported Outcome (HR-PRO) are an adequate reflection of the dimensionality of the construct to be measured" (Mokkink et al., 2010).
3 months
Secondary Outcomes (1)
Reliability
3 months
Interventions
Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. The Michigan Hand Questionnaire is one of the most important.
Eligibility Criteria
Native Italian speaking patients followed by the Hand Therapy of the University Hospital Zürich and the Handtherapy Fairplay center of Bologna, IT, with a pathology of the hand/s and or wrist/s.
You may qualify if:
- age \> 18 years
- native Italian speakers
- wrist/hand pathology
- trauma (fractures, tendon injuries, etc.)
- chronic pathology, the pathology has been present for at least 1 month (tenosynovitis, chronic arthrosis pain, rheumatic hand or wrist disorders)
- in case of hand/wrist surgery: at least 4 weeks have elapsed since surgery to avoid that the patient could not perform certain actions evaluated by the scale, for example lifting a pan or shopping bags, due to normal post-operative precautions.
- full possession of mental capacity
You may not qualify if:
- age \< 18 years
- non-native Italian speakers of Italian, thus also excluding second generation Swiss Italians ("secundo")
- mental incapacity
- upper limb in cast/locked by splint (criterion in Chung's article 98) at the time of the evaluation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maurizio Calcagni, MD
University Hospital, Zürich
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 22, 2020
First Posted
August 26, 2020
Study Start
December 1, 2021
Primary Completion
December 10, 2021
Study Completion
December 10, 2021
Last Updated
January 3, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share
Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. Some of the most used Questionnaires, unfortunately, are not available in Italian. This poses a problem when evaluating Italian speaking patients. Our aim is to develop a culturally adapted Italian version of the Michigan Hand Questionnaire. There is no risk involved for the patients, as the task of the recruited patients is to answer a survey (online and in clinics).