NCT07341594

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 16, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 6, 2026

Last Update Submit

January 6, 2026

Conditions

Keywords

distal radius fractureminimal clinically important differencethe push-off test

Outcome Measures

Primary Outcomes (4)

  • Range of Motion (ROM) Measurement

    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)

    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)

    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

    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.

Study Arms (1)

All patients

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

Other: Physical therapy

Interventions

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.

All patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Related Publications (2)

  • 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: 24794466BACKGROUND
  • 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: 29102478BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Central Study Contacts

HANDE USTA OZDEMIR, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 14, 2026

Study Start

January 16, 2026

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

June 12, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations