Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:34 AM
Study NCT ID:
NCT07341594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-14
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimal Clinically Important Difference of the Push-Off Test
Sponsor:
Pamukkale University
Organization:
Study Overview
Official Title:
Determination of the Minimal Clinically Important Difference of the Push-Off Test in Distal Radius Fractures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim was to determine the minimal clinically important difference of the push-off test in distal radius fractures.
Detailed Description:
To interpret a treatment effect and a change that is meaningful for the patient, it is important to use the minimal clinically important difference (MCID) of the push-off test (POT). The MCID represents the smallest numerical change that can be perceived as beneficial by the patient. A numerical change smaller than the MCID, even if statistically significant, does not represent a clinically meaningful change. Because the MCID defines a difference that is considered important for patients, it can also serve as a basis for estimating the required sample size in the design of future studies.
Another important metric is the minimal detectable change (MDC). The MDC represents the smallest amount of change that exceeds the measurement error of an instrument. Therefore, any change smaller than the MDC may be the result of measurement variability. To ensure that the MDC is sufficiently small to detect the MCID, the MCID should be greater than the MDC. The MDC of the POT has been investigated in patients with wrist or elbow pathologies; however, to date, the MCID has not been established in patients with distal radius fractures.
In summary, the POT is a test that objectively evaluates axial loading of the upper extremity in the presence of hand or wrist pathology. However, to ensure the reliability of preliminary findings and to support its integration into hand therapy practice, further studies are needed to evaluate its measurement properties using specific patient samples.
Another important metric is the minimal detectable change (MDC). The MDC represents the smallest amount of change that exceeds the measurement error of an instrument. Therefore, any change smaller than the MDC may be the result of measurement variability. To ensure that the MDC is sufficiently small to detect the MCID, the MCID should be greater than the MDC. The MDC of the POT has been investigated in patients with wrist or elbow pathologies; however, to date, the MCID has not been established in patients with distal radius fractures.
In summary, the POT is a test that objectively evaluates axial loading of the upper extremity in the presence of hand or wrist pathology. However, to ensure the reliability of preliminary findings and to support its integration into hand therapy practice, further studies are needed to evaluate its measurement properties using specific patient samples.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: