NCT06565481|Unknown
Measurement Properties in People with Hemophilia
HEMOPRO
Measurement Properties (Reliability and Validity) of a Set of Assessments Evaluating Physical Function in People with Hemophilia
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HEMOPRO
Measurement Properties (Reliability and Validity) of a Set of Assessments Evaluating Physical Function in People with Hemophilia
Sponsor study identifier
interventional
50
1 country
1
Study Start
October 31, 2024
Actual (reported)Primary Completion
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 23, 2024
Actual (reported)August 22, 2024
Actual (reported)October 31, 2024
Actual (reported)May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Short Physical Performance Battery (SPPB)
SPPB comprises three components: Standing balance (open stand, half tandem stand and tandem stand), timed four meter usual paced walk, and timed test of five sit-to-stands from a standard chair. Each component is scored from 0 to 4, with maximum of 12and timed test of five sit-to-stands from a standard chair.
Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
Four Square Step Test (FSST)
The FSST is a performance-based outcome measure assessing dynamic balance. The test set up consists of four walking sticks of the same width in a cross formation. Participants step into each square in a clockwise sequence and back anticlockwise as fast as possible while not being allowed to hit the sticks.
Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
Timed up and Go (TUG)
The TUG is a performance-based outcome measure that assesses lower extremity function, mobility, and fall risk. In this test, the participant starts in a seated position, with his back against a standard height chair, without armrest. The participant gets up and walks in a comfortable pace for 10 feet (three meters), turns around and returns to a seated position in the chair. The time to perform the task is measured in seconds. Shorter time indicates better mobility.
Short Form 36
Baseline (Day 1)
Hemophilia Activities List
Baseline (Day 1)
Hemophilia Joint Health Score Version 2.1
Baseline (Day 1)
This study, including two time points, is performed to determine validity and reliability of performance based assessments using a one-arm sample. A test retest design is used to determine reliability and a cross-sectional design to determine validity. For each participant, the measures will be performed on two time points with a minimal recovery break of 2 days in one single centre in the Canton of Zurich (University Hospital Zurich).
This study evaluates the reliability (Test-Retest) of six health related instruments that assess physical function in people with hemophilia: Short Physical Performance Battery, Unipedal Stance Test, Four Square Step Test, Timed up and Go, 1 kg Arm Lift Test, 30 Second Chair Stand Test. This study is needed to determine the psychometric properties of these six assessments. Validity of these test will be determined with the Short Form 36, the Hemophilia Activities List and the Hemophilia Joint Health Score Methodology: Reliability (Test re-test study and validity (cross sectional study) of the six tests reported in patients with hemophilia. This intervention contains physiotherapie assessments, however, no drugs nor medical devices.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ruud Knols
Zurich, 8091, Switzerland
Ruud Knols, PhD
University of Zurich
First Submitted
July 23, 2024
First Posted
August 22, 2024
Study Start
October 31, 2024
Actual (reported)Personalized Medicine for Canadians With Hemophilia
Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
Unipedal Stance Test (UST)
The UST is a balance assessment that is widely used in clinical settings to monitor neurological and musculoskeletal conditions. Abnormal values may indicate conditions that may impair balance and will quantify balance status for those who are at increased risks for fall. The test is performed barefoot, hands crossed over the chest and once with eyes open and once with eyes closed. Patient stands on one leg unassisted; time begins when opposite foot leaves the ground. Time stops immediately when arms are uncrossed, the raised foot is used to maintain balance or touches the ground, weight-baring foot is moved, 45 second have elapsed or when eyes were opened on eyes closed trial. Each condition (eyes open or eyes closed) is performed three times, alternatively.
Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
30-Second Stair Stand Test
The 30-Second Chair Stand Test measures the muscle function of the lower extremity by counting how many times a patient rises from a seated position to a full stand at his/her own pace
Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
1 kg Arm Lift Test
The 1 kg arm lift test measures the muscle function of the upper extremity. It counts how many time a patient can lift a 1 kilogram weight above their head within 30 seconds at his/her own pace
Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
Contact the study team to confirm eligibility.
Primary Completion
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 14, 2025
Record last verified: 2024-08
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Source: ClinicalTrials.gov.
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