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NCT Number: NCT07341594

Minimal Clinically Important Difference of the Push-Off Test

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

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

HANDE USTA OZDEMIR, PhD

CONTACT

[email protected]

+902582964279

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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