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Italian Translation of the Michigan Hand Outcomes Questionnaire

Italian Translation and Cross-cultural Adaptation of the Michigan Hand Outcomes Questionnaire

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04527588
Enrollment
0
Registered
2020-08-26
Start date
2021-12-01
Completion date
2021-12-10
Last updated
2022-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Fracture, Hand Injury Wrist, Hand Osteoarthritis, Hand Sprain, Wrist Arthritis, Wrist Fracture, Wrist Injuries

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.

Detailed description

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).

Interventions

OTHERQuestionaire Michigan

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.

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Validity3 monthsValidity 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).

Secondary

MeasureTime frameDescription
Reliability3 monthsReliability will be assessed as internal consistency (i.e., the degree of the interrelatedness among the items \[Mokkink et al., 2010\]), test-retest reliability (i.e., the proportion of the total variance in the measurements which is due to 'true' differences between patients \[Mokkink et al., 2010\]), and measurement error (i.e., the systematic and random error of a patient's score that is not attributed to true changes in the construct to be measured \[Mokkink et al., 2010\]).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026