Secondary PreventionNCT06258928
Early Mobilisation of the Distal Radius Fracture
An observational study of Secondary Prevention, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial summary
The goal of this clinical trial is to demonstrate the effectiveness of early therapy in 14 patients with a distal radius fracture DRF resulting from injury, as the study group. Assess hand function of patients who underwent surgical repair of distal radius fractures using the open reduction internal fixation method… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Secondary Prevention
- What is being tested?
- Functional examination
- How many people
- 15 participants
- Where
- 1 sitePoland
- Study dates
- 4 Mar 2024to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with a distal radius fracture DRF resulting from injury
Who may be able to join
- age range 18-60 years
- distal radius fracture
- ORIF procedure
- hand stabilisation plate (Medartis)
Who cannot join
- delayed rehabilitation protocol
- algodystrophy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Terapia Ręki Magda Kolasińska
Warsaw, Masovian Voivodeship, 01-494
About this study
Official title: Early Mobilisation of the Distal Radius Fracture Isokinetic and Functional Evaluation
The goal of this clinical trial is to demonstrate the effectiveness of early therapy in 14 patients with a distal radius fracture DRF resulting from injury, as the study group. Assess hand function of patients who underwent surgical repair of distal radius fractures using the open reduction internal fixation method (ORIF), compared to their nonoperated limb, after 6 months of early rehabilitation.
The main questions it aims to answer are:
Read more
- Significantly faster recovery of independence from daily activities by the patient.
- For economic reasons, patients often expect to return to work as soon as possible.
Participants will be subjected to functional examination to assess hand function of patients who underwent surgical repair of distal radius fractures using the open reduction internal fixation method.
- Conditions
- Secondary Prevention
- Being tested
- Functional examination
- Keywords
- distal radius fracture, early therapy, exercise therapy
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional examinationDiagnostic test
Compared to nonoperated limb, after 6 months of early rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| patients with a distal radius fracture | Functional examination included evaluating range of motion (ROM), grip strength, and isokinetic evaluation of force moments (Biodex) for wrist flexion, extension, forearm pronation, and forearm supination. Michigan's questionnaire and the Disability of the Arm, Shoulder, and Hand (DASH) questionnaire were used to subjectively evaluate the effects of therapy. Receives: Diagnostic Test: Functional examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH -Disability of the Arm, Shoulder, and Hand
questionnaire assesses upper limb disability and consists of 30 questions in the general section and an additional work module with 4 questions and a sport/instrument playing module with 4 questions. Assess symptoms and the inability to perform certain activities based on health status.
Measured: 1 day
ROM - range of motion
Flexion, extension of the wrist, supination and pronation of the forearm using a 15 cm stainless steel Saehan finger goniometer
Measured: 1 day
Grip strength
Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength
Measured: 1 day
Isokinetic evaluation
Isokinetic evaluation of force moments of the biceps and triceps, and the muscles responsible for supination and pronation of the forearm using the Biodex System 4 Pro (Biodex, USA) dynamometer.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start4 Mar 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary PreventionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Kolasińska, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258928
- Sponsor's protocol ID
- Radius Fracture
- Status last verified
- Aug 2025
- First submitted
- 3 Feb 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilisation of the Distal Radius Fracture Isokinetic and Functional Evaluation
- ClinicalTrials.gov ID
- NCT06258928
- Acronym / sponsor ID
- Radius Fracture
- Conditions
- Secondary Prevention
- Keywords
- distal radius fracture, early therapy, exercise therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 14 Feb 2024 (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 goal of this clinical trial is to demonstrate the effectiveness of early therapy in 14 patients with a distal radius fracture DRF resulting from injury, as the study group. Assess hand function of patients who underwent surgical repair of distal radius fractures using the open reduction internal fixation method (ORIF), compared to their nonoperated limb, after 6 months of early rehabilitation.
The main questions it aims to answer are:
- Significantly faster recovery of independence from daily activities by the patient.
- For economic reasons, patients often expect to return to work as soon as possible.
Participants will be subjected to functional examination to assess hand function of patients who underwent surgical repair of distal radius fractures using the open reduction internal fixation method.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a distal radius fracture | – | Diagnostic Test: Functional examinationFunctional examination included evaluating range of motion (ROM), grip strength, and isokinetic evaluation of force moments (Biodex) for wrist flexion, extension, forearm pronation, and forearm supination. Michigan's questionnaire and the Disability of the Arm, Shoulder, and Hand (DASH) questionnaire were used to subjectively evaluate the effects of therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with a distal radius fracture DRF resulting from injury
Key inclusion criteria (4 listed)
- age range 18-60 years
- distal radius fracture
- ORIF procedure
- hand stabilisation plate (Medartis)
Key exclusion criteria (2 listed)
- delayed rehabilitation protocol
- algodystrophy
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 |
|---|---|---|
| Functional examinationCompared to nonoperated limb, after 6 months of early rehabilitation. | Diagnostic test | patients with a distal radius fracture |
Primary outcome
DASH -Disability of the Arm, Shoulder, and Hand
Time frame: 1 day
questionnaire assesses upper limb disability and consists of 30 questions in the general section and an additional work module with 4 questions and a sport/instrument playing module with 4 questions. Assess symptoms and the inability to perform certain activities based on health status.
ROM - range of motion
Time frame: 1 day
Flexion, extension of the wrist, supination and pronation of the forearm using a 15 cm stainless steel Saehan finger goniometer
Grip strength
Time frame: 1 day
Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength
Isokinetic evaluation
Time frame: 1 day
Isokinetic evaluation of force moments of the biceps and triceps, and the muscles responsible for supination and pronation of the forearm using the Biodex System 4 Pro (Biodex, USA) dynamometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Secondary Prevention, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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: finished, as of the sponsor's last update on 3 Sep 2025. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH -Disability of the Arm, Shoulder, and Hand (time frame: 1 day). 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?
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 3 Sep 2025.