Minimal Clinically Important Difference of the Push-Off Test

NCT ID: NCT07341594

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-16

Study Completion Date

2026-06-12

Brief Summary

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

Detailed Description

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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.

Conditions

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Distal Radius Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

All patients diagnosed with distal radius fractures who were treated conservatively or surgically

Physical therapy

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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HANDE USTA

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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HANDE USTA OZDEMIR, PhD

Role: CONTACT

+902582964279

Facility Contacts

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HANDE USTA OZDEMIR, PhD

Role: primary

+902582964279

References

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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.

Reference Type BACKGROUND
PMID: 24794466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29102478 (View on PubMed)

Other Identifiers

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E-60116787-020-804778

Identifier Type: -

Identifier Source: org_study_id

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