Hand FractureNCT04527588
Italian Translation of the Michigan Hand Outcomes Questionnaire
An observational study of Hand Fracture and Hand Osteoarthritis, run by University of Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Fracture, Hand Osteoarthritis, Hand Injury Wrist
- What is being tested?
- Questionaire Michigan
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 10 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Italian Translation and Cross-cultural Adaptation of the Michigan Hand Outcomes Questionnaire
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.
Read the 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).
- Conditions
- Hand Fracture, Hand Osteoarthritis, Hand Injury Wrist, Hand Sprain, Wrist Injuries, Wrist Fracture
- Being tested
- Questionaire Michigan
- Medical subject headings
- Wrist Injuries, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionaire MichiganOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (1)
Reliability
Reliability 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]).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Dec 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Why it stopped: same study was published from another group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand FractureStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Calcagni, University of Zurich
- Investigators
- Maurizio Calcagni, MD, Study director, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527588
- Sponsor's protocol ID
- Michigan2020.USZ
- Status last verified
- Dec 2021
- First submitted
- 22 Aug 2020
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Translation and Cross-cultural Adaptation of the Michigan Hand Outcomes Questionnaire
- ClinicalTrials.gov ID
- NCT04527588
- Acronym / sponsor ID
- Michigan2020.USZ
- Conditions
- Hand Fracture, Hand Osteoarthritis, Hand Injury Wrist, Hand Sprain, Wrist Injuries, Wrist Fracture
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: same study was published from another group
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionaire MichiganPatient-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. | Other | – |
Primary outcome
Validity
Time frame: 3 months
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).
1 secondary outcome
Reliability
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Calcagni, MD study director
University Hospital, Zürich
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Fracture and Hand Osteoarthritis, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.