Distal Radius FracturesNCT06866340
Evaluation of Limb Function and Perception in Rehabilitation After Traumatic Wrist Fracture Surgery
An observational study of Distal Radius Fractures and Rehabilitation, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures, Rehabilitation, Body Perception
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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?
Read more
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
- Medical subject headings
- Wrist Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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: Measured at T0 (before rehabilitation, after immobilization), T1 (start of rehabilitation), and T2 (end of rehabilitation, 4-10 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Collaborators
- HES-SO Valais-Wallis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866340
- Sponsor's protocol ID
- POLSO24 (L3057)
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06866340
- Acronym / sponsor ID
- POLSO24 (L3057)
- Conditions
- Distal Radius Fractures, Rehabilitation, Body Perception
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Collaborators
- HES-SO Valais-Wallis
- Study start
- 1 May 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Distal Radius Fractures
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fractures and Rehabilitation, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TITO BASSANI, PhD (+390283502244, tito.bassani@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.