Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565481
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Measurement Properties in People With Hemophilia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Measurement Properties Reliability and Validity of a Set of Assessments Evaluating Physical Function in People With Hemophilia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEMOPRO
Brief Summary:
The aim of this project is to determine the measurement properties namely reliability and validity of a set of clinical assessments measuring different aspects of physical function
Detailed Description:
The medical treatment of hemophilia has advanced greatly in recent years There are now medications that reduce the physical symptoms of hemophilia Nevertheless those affected by hemophilia suffer from restricted mobility reduced strength reduced balance and pain as a result of the repeated bleeding In order to make well-founded decisions regarding possible supportive therapeutic or medical measures it is important to be able to estimate the extent of such limitations and whether these will change or remain stable
The study is needed to validate the measurement properties of measurement instruments used to measure the effects of physical training interventions in participants with hemophilia Clinical questions can only be solved if measuring instruments with sufficient measuring properties are used These measurement properties must be evaluated in a relevant population Otherwise health professionals cannot assess whether measures or treatment are not effective or whether measured changes are not large enough to detect an actual change Therefore research is required to ensure that adequately studied measurement instruments are available for clinical assessment of those affected by adult participants with hemophilia
Some of the tests such as the Unipedal Stance Test or Four Square Step Test have already been studied in children with hemophilia or in participants with other diseases Since hemophilia is a disease with specific effects the measuring instruments must also be researched in this participant group There is still a research gap that the investigators would like to close with this study For the study the investigators selected tests that are already being used on adult participants with hemophilia and have had good experiences in practice The tests are safe and can be carried out with little strain
The study is needed to validate the measurement properties of measurement instruments used to measure the effects of physical training interventions in participants with hemophilia Clinical questions can only be solved if measuring instruments with sufficient measuring properties are used These measurement properties must be evaluated in a relevant population Otherwise health professionals cannot assess whether measures or treatment are not effective or whether measured changes are not large enough to detect an actual change Therefore research is required to ensure that adequately studied measurement instruments are available for clinical assessment of those affected by adult participants with hemophilia
Some of the tests such as the Unipedal Stance Test or Four Square Step Test have already been studied in children with hemophilia or in participants with other diseases Since hemophilia is a disease with specific effects the measuring instruments must also be researched in this participant group There is still a research gap that the investigators would like to close with this study For the study the investigators selected tests that are already being used on adult participants with hemophilia and have had good experiences in practice The tests are safe and can be carried out with little strain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None