Distal Radius FractureNCT07341594
Minimal Clinically Important Difference of the Push-Off Test
An observational study of Distal Radius Fracture, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim was to determine the minimal clinically important difference of the push-off test in distal radius fractures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Physical therapy
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2026to 12 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Pamukkale University
Denizli
HANDE USTA OZDEMIR, PhD, +902582964279, husta@pau.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Distal Radius Fracture
- Being tested
- Physical therapy
- Keywords
- distal radius fracture, minimal clinically important difference, the push-off test
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| All patients | All patients diagnosed with distal radius fractures who were treated conservatively or surgically Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessments will be performed at the 12th and 18th weeks after the fracture.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start16 Jan 2026 (estimated)
- Primary completion5 Jun 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE USTA, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341594
- Sponsor's protocol ID
- E-60116787-020-804778
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will be shared upon reasonable request after publication of the study results.
Publications
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.
PubMed 24794466Mehta 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.
PubMed 29102478
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Minimal Clinically Important Difference of the Push-Off Test in Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT07341594
- Acronym / sponsor ID
- E-60116787-020-804778
- Conditions
- Distal Radius Fracture
- Keywords
- distal radius fracture, minimal clinically important difference, the push-off test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 16 Jan 2026 (estimated)
- Primary completion
- 5 Jun 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Other: Physical therapyAll patients diagnosed with distal radius fractures who were treated conservatively or surgically |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapyFor 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. | Other | All patients |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 24794466Vincent 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.
- Background: PubMed 29102478Mehta 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.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will be shared upon reasonable request after publication of the study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HANDE USTA OZDEMIR, PhD (+902582964279, husta@pau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (ROM) Measurement (time frame: Assessments will be performed at the 12th and 18th weeks after the fracture.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07341594, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.