Clinical trial NCT06866340: Evaluation of Limb Function and Perception in Rehabilitation After Traumatic Wrist Fracture Surgery
Official title: Evaluation of the Functionality and Perception of the Injured Limb in the Rehabilitation Process of Orthopedic Patients Undergoing Surgical Treatment for Traumatic Wrist Fracture
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Distal Radius Fractures
Rehabilitation
Body Perception
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
Collaborators: name: HES-SO Valais-Wallis
First posted: 2025-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Correlation between functional and perceptual alterations at the beginning and end of rehabilitation
timeFrame: Measured at T1 (start of rehabilitation) and T2 (end of rehabilitation, 4-10 weeks later)
Secondary outcomes:
measure: Effect of functional and perceptual alterations on rehabilitation duration and effectiveness
timeFrame: Measured at T0 (before rehabilitation, after immobilization), T1 (start of rehabilitation), and T2 (end of rehabilitation, 4-10 weeks later)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio
Study officials:
References: