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Not yet recruiting NCT07341594

Minimal Clinically Important Difference of the Push-Off Test

— Observational Distal Radius Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical therapy.
Who it may be relevant to
Registry conditions: Distal Radius Fracture. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Determination of the Minimal Clinically Important Difference of the Push-Off Test in Distal Radius Fractures

Overview

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.

Interventions

  • Other Physical therapy
    For all patients treated conservatively or surgically, active range of motion exercises for the hand, wrist, and forearm will be initiated after cast removal or on the first postoperative day, respectively. To control edema, bandaging, contrast baths, and retrograde massage will be recommended. In the subsequent weeks of rehabilitation, resisted exercises for the hand, wrist, and forearm will be introduced. All patients will be followed with a home exercise program and will be scheduled for foll

Primary outcome measures

  • Range of Motion (ROM) Measurement [Time frame: Assessments will be performed at the 12th and 18th weeks after the fracture.]
  • Patient-Rated Wrist Evaluation (PRWE) [Time frame: Assessments will be performed at the 12th and 18th weeks after the fracture.]
  • Push-Off Test (POT) [Time frame: Assessments will be performed at the 12th and 18th weeks after the fracture.]
  • Gross Grip Strength Test [Time frame: Assessments will be performed at the 12th and 18th weeks after the fracture.]

Eligibility criteria

Inclusion criteria

  • Diagnosis of distal radius fracture (DRF) and treatment with either conservative or surgical methods
  • Voluntary participation
  • Age between 18 and 65 years
  • Having a cognitive level sufficient to understand the assessment methods and follow instructions

Exclusion criteria

  • Presence of concomitant musculoskeletal or neurovascular injuries in the affected extremity
  • Presence of a neurological, orthopedic, rheumatologic, or metabolic condition that could affect the affected extremity

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Pamukkale University — Denizli

Publications

  • Vincent JI, MacDermid JC, Michlovitz SL, Rafuse R, Wells-Rowsell C, Wong O, Bisbee L. The push-off test: development of a simple, reliable test of upper extremity weight-bearing capability. J Hand Ther. 2014 Jul-Sep;27(3):185-90; quiz 191. doi: 10.1016/j.jht.2014.03.002. Epub 2014 Mar 12. PMID 24794466
  • Mehta SP, George HR, Goering CA, Shafer DR, Koester A, Novotny S. Reliability, validity, and minimal detectable change of the push-off test scores in assessing upper extremity weight-bearing ability. J Hand Ther. 2019 Jan-Mar;32(1):103-109. doi: 10.1016/j.jht.2017.09.008. PMID 29102478

Identifiers

NCT: NCT07341594 · E-60116787-020-804778

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗