- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06866340
Evaluation of Limb Function and Perception in Rehabilitation After Traumatic Wrist Fracture Surgery
Evaluation of the Functionality and Perception of the Injured Limb in the Rehabilitation Process of Orthopedic Patients Undergoing Surgical Treatment for Traumatic Wrist Fracture
The goal of this observational study is to assess the functional and perceptual alterations of the affected limb during rehabilitation in adult orthopedic patients who underwent surgical treatment for distal radius fractures. The main questions it aims to answer are:
What is the correlation between functional and perceptual alterations of the affected limb at the beginning and end of rehabilitation? How do these alterations influence rehabilitation duration and effectiveness?
Participants will:
Complete the patient questionnaires ((QuickDASH and ALPQ). Undergo handgrip strength tests and digital dynamometer tests to assess forearm muscle strength.
Have their range of motion evaluated by a physiotherapist during outpatient visits.
No additional diagnostic or instrumental examinations are required beyond routine clinical practice. The study will recruit 100 adult patients, last 24 months, and provide insights into the role of body perception in rehabilitation after wrist fractures.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: TITO BASSANI, PhD
- Phone Number: +390283502244
- Email: tito.bassani@grupposandonato.it
Study Locations
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-
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Milano, Italy, 20157
- IRCCS Ospedale Galeazzi-Sant'Ambrogio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study will include adult orthopedic patients undergoing rehabilitation after surgical treatment for a traumatic distal radius fracture. Participants will be recruited from the Hand Surgery Unit at IRCCS Ospedale Galeazzi - Sant'Ambrogio (Milan, Italy).
Eligible patients must have undergone volar approach surgery for an isolated wrist fracture and will start a structured rehabilitation program following a 5-week immobilization period.
Excluded from participation are individuals with neurological, psychiatric, or cognitive disorders, prior fractures in the same limb, or those who are pregnant or breastfeeding.
A total of 100 participants will be consecutively enrolled to ensure a representative sample for statistical analysis.
Description
Inclusion Criteria:
- Adults (≥18 years old)
- Patients who have undergone surgical treatment with a volar approach for a traumatic distal radius fracture at IRCCS Ospedale Galeazzi - Sant'Ambrogio.
- Willingness and ability to provide written informed consent.
Exclusion Criteria:
- Pre-existing neurological, psychiatric, or cognitive disorders that could affect motor function or body perception.
- Previous fractures of the same limb.
- Pregnancy or breastfeeding (self-reported).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between functional and perceptual alterations at the beginning and end of rehabilitation
Time Frame: Measured at T1 (start of rehabilitation) and T2 (end of rehabilitation, 4-10 weeks later)
|
The study will evaluate the relationship between functional parameters (grip strength, range of motion, QuickDASH score) and perceptual parameters (ALPQ score for body perception).
|
Measured at T1 (start of rehabilitation) and T2 (end of rehabilitation, 4-10 weeks later)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of functional and perceptual alterations on rehabilitation duration and effectiveness
Time Frame: Measured at T0 (before rehabilitation, after immobilization), T1 (start of rehabilitation), and T2 (end of rehabilitation, 4-10 weeks later)
|
Examines how initial functional and perceptual impairments influence: Rehabilitation duration (measured in weeks and number of therapy sessions). Rehabilitation effectiveness (difference in QuickDASH, ALPQ, strength, and range of motion scores between T1 and T2). |
Measured at T0 (before rehabilitation, after immobilization), T1 (start of rehabilitation), and T2 (end of rehabilitation, 4-10 weeks later)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- POLSO24 (L3057)
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
product manufactured in and exported from the U.S.
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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