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

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Milano, Italy, 20157
        • IRCCS Ospedale Galeazzi-Sant'Ambrogio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • POLSO24 (L3057)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Rehabilitation

Subscribe