Evaluation of Limb Function and Perception in Rehabilitation After Traumatic Wrist Fracture Surgery

NCT06866340 | Not Yet Recruiting

• 1 other identifier: POLSO24 (L3057)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Distal Radius Fractures; Rehabilitation; Body Perception

Outcome Measures

Primary Outcomes (1)

• Correlation between functional and perceptual alterations at the beginning and end of rehabilitation

  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 Outcomes (1)

• Effect of functional and perceptual alterations on rehabilitation duration and effectiveness

  Measured at T0 (before rehabilitation, after immobilization), T1 (start of rehabilitation), and T2 (end of rehabilitation, 4-10 weeks later)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead
• HES-SO Valais-Wallis: collaborator

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy, 20157, Italy

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

TITO BASSANI, PhD

CONTACT

+390283502244; tito.bassani@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-03

Locations

IT (1)