- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06258928
Early Mobilisation of the Distal Radius Fracture
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:
- 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Poland, 01-494
- Terapia Ręki Magda Kolasińska
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age range 18-60 years
- distal radius fracture
- ORIF procedure
- hand stabilisation plate (Medartis)
Exclusion Criteria:
- delayed rehabilitation protocol
- algodystrophy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Compared to nonoperated limb, after 6 months of early rehabilitation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 day
|
|
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
|
1 day
|
|
Grip strength
Time Frame: 1 day
|
Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength
|
1 day
|
|
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.
|
1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Radius Fracture
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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