Minimal Clinically Important Difference of the Push-Off Test

January 6, 2026 updated by: HANDE USTA, Pamukkale University

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

The aim was to determine the minimal clinically important difference of the push-off test in distal radius fractures.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: HANDE USTA OZDEMIR, PhD
  • Phone Number: +902582964279
  • Email: husta@pau.edu.tr

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who were diagnosed with distal radius fractures, treated conservatively or surgically, and referred to the Hand Rehabilitation Unit from the Division of Hand Surgery, Department of Orthopedics and Traumatology, Pamukkale University Health Research and Application Center will be included in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
All patients diagnosed with distal radius fractures who were treated conservatively or surgically
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 follow-up visits once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion (ROM) Measurement
Time Frame: Assessments will be performed at the 12th and 18th weeks after the fracture.
Forearm pronation and supination, as well as wrist flexion, extension, radial deviation, and ulnar deviation, will be measured using a universal goniometer.
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.
The questionnaire assesses the severity of wrist pain and the level of disability in activities of daily living. It consists of two subscales comprising a total of 15 items. The pain subscale includes questions related to pain intensity and frequency, while the function subscale consists of six items related to specific activities and four items related to usual daily activities.
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.
The POT determines the amount of force that an individual can transmit through the upper extremity. The measurement is performed using a hand dynamometer with the dynamometer handle inverted. The test is conducted while the participant is standing at the edge of a high table, and compensatory movements are not permitted. The tested extremity is positioned with the shoulder in approximately 30° of extension, the elbow in 30° of flexion, and the forearm, wrist, and hand positioned in a manner comfortable for the individual. Measurements are repeated three times for each extremity, and the mean value is recorded in kilograms.
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.
Grip strength is measured using a hand dynamometer in accordance with the standard measurement protocol of the American Society of Hand Therapists.
Assessments will be performed at the 12th and 18th weeks after the fracture.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 16, 2026

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

June 12, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-60116787-020-804778

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) will be shared upon reasonable request after publication of the study results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Distal Radius Fracture

Clinical Trials on Physical therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe