- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07008430
- Original Trial
Angle Specific Torque Profiles After Distal Radius Fracture
Angle-Specific Torque Profiles of Wrist, Forearm and Elbow Movements After Distal Radius Fracture
Distal radius fracture (DRF) is one of the most common upper extremity injuries and can lead to long-term kinesiological and anatomical alterations despite proper surgical fixation and rehabilitation. This retrospective cohort study aims to analyze the angle-specific torque characteristics of wrist (flexion/extension), forearm (supination/pronation), and elbow (flexion/extension) movements in patients with a history of DRF treated by volar plate fixation.
The study will utilize archived raw data of 37 eligible patients who underwent isokinetic strength testing during the post-rehabilitation period. Data will be extracted from Cybex NORM® and Humac isokinetic dynamometer systems and analyzed using Statistical Parametric Mapping (SPM) with the open-source spm1d package in MATLAB. This analysis will generate 101-point angle-dependent torque curves for each joint movement and will be used to evaluate interlimb asymmetry, angle of peak torque production, and unilateral agonist/antagonist torque ratios.
Additionally, radiographic images archived during the treatment period will be analyzed to measure radial inclination, palmar tilt, and ulnar variance using the Dresdner scoring system. The torque profiles and radiological parameters will be statistically analyzed with SPSS. Between-limb comparisons and symmetry indices will be calculated using repeated-measures ANOVA, t-tests or non-parametric alternatives, depending on data distribution.
This research is expected to provide new insights into the kinesiological consequences of DRF by presenting detailed angle-specific torque characteristics, going beyond conventional peak torque and range of motion assessments commonly seen in the literature.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Çiğli
-
İzmir, Çiğli, Turkey, 35620
- Izmir Katip Çelebi University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with distal radius fractures reduced with a volar plate will be included.
Exclusion Criteria:
- Patients with bilateral injuries, fractures in bones other than the radius, stabilization methods other than volar plate, and any other neurological or orthopedic condition that may affect the evaluation will be excluded from the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Angle Specific Torque Profiles
Time Frame: 1 year
|
Raw data files of both the injured and uninjured upper limbs of eligible patients will be obtained from the system records of the isokinetic dynamometer. These raw data will be analyzed using the open-source spm1d package within the MATLAB software (R2021b, The MathWorks Inc., Natick, MA) through statistical parametric mapping (SPM). Accordingly, torque/angle data produced during the full range of motion on the isokinetic dynamometer will be divided into 101 intervals to construct angle-dependent torque profiles (SPM analysis) for each movement. SPM analysis will be conducted for wrist flexors and extensors, forearm supinators and pronators, and elbow flexors and extensors. Through this analysis, the following parameters will be examined: the angle-dependent torque characteristics of the injured and uninjured limbs, the unilateral angle-dependent agonist/antagonist torque profiles, and the angle at which peak torque occurs. |
1 year
|
Collaborators and Investigators
Sponsor
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8
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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