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Minimal Clinically Important Difference of the Push-Off Test

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07341594
Enrollment
109
Registered
2026-01-14
Start date
2026-01-16
Completion date
2026-06-12
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture

Keywords

distal radius fracture, minimal clinically important difference, the push-off test

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.

Interventions

OTHERPhysical 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.

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Range of Motion (ROM) MeasurementAssessments 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.
Patient-Rated Wrist Evaluation (PRWE)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.
Push-Off Test (POT)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.
Gross Grip Strength TestAssessments 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactHANDE USTA OZDEMIR, PhD
husta@pau.edu.tr+902582964279

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026