NCT04527588

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

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Status
withdrawn

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

9 days

First QC Date

August 22, 2020

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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

Wrist InjuriesWrist Fractures

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Maurizio Calcagni, MD

    University Hospital, Zürich

    STUDY DIRECTOR
0

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).