Shoulder ArthroplastyVIRNCT07282561
Role of Nutritional Status in Functional Recovery of Older Adults Undergoing Virtual Reality-augmented Shoulder Rehabilitation (VIR)
A study testing Oculus Quest in people with Shoulder Arthroplasty and Rehabilitation, run by Claudio Pedone at 1 site in Italy.
Trial summary
Malnutrition is a clinical syndrome defined by involuntary weight loss and/or a persistent imbalance between nutritional needs and intake, leading to functional decline. Its prevalence is particularly high among older adults-affecting about 17% of community-dwelling elders, 30% of those in rehabilitation settings, and… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Shoulder Arthroplasty, Rehabilitation, Virtual Reality
- What is being tested?
- Oculus Quest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2025to 30 Oct 2026
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 60 years old or older;
- Frailty defined according to the Clinical Frailty Scale (Cesari et al., 2018);
- Diagnosis of shoulder diseases with indication to elective surgery;
Who cannot join
- Diagnosis of rheumatic diseases;
- Shoulder fracture;
- Actual SARS-CoV-2 infection;
- Diagnosis of active cancer;
- Any contraindication to oral feeding;
- Malabsorptive diseases;
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- Cognitive impairment (MMSE<18);
- Severe chronic diseases (heart failure NYHA III-IV, lung failure, renal failure);
- Any contraindication to rehabilitation;
- Rehabilitation duration ≤ 14 days;
- Inability to provide an informed consent;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, 00128
Claudio Pedone, Prof, +39 06 22 541 1349, c.pedone@policlinicocampus.it
About this study
Malnutrition is a clinical syndrome defined by involuntary weight loss and/or a persistent imbalance between nutritional needs and intake, leading to functional decline. Its prevalence is particularly high among older adults-affecting about 17% of community-dwelling elders, 30% of those in rehabilitation settings, and between 20% and 60% of individuals in acute care environments. Malnutrition is therefore a common yet often underrecognized factor influencing health outcomes in geriatric populations.
Osteoarthritis (OA), a degenerative joint disease marked by the deterioration of articular cartilage, results in pain and reduced mobility. It affects approximately 9.6% of men and 18% of women over the age of 60. With global life expectancy rising and populations aging, OA is projected to become the fourth leading cause of disability by 2025. Joint replacement surgery provides significant relief for severe cases, and consequently, an increasing number of adults-averaging around 70 years of age-undergo elective joint replacement surgeries followed by rehabilitation for degenerative OA.
Read more
In this context, Virtual Reality (VR) technology is emerging as an innovative tool in rehabilitation. VR can create engaging, interactive environments that promote motor relearning by allowing clinicians to adjust practice intensity and provide real-time feedback. This adaptability enables personalized rehabilitation programs designed to enhance patient motivation and adherence. Preliminary studies have shown encouraging results, suggesting that VR-assisted therapy may improve motor recovery and functional outcomes, and its use in rehabilitation settings is rapidly expanding.
Previous research has identified a strong link between malnutrition and sarcopenia (loss of muscle mass) and reduced physical performance. However, findings remain inconsistent regarding how nutritional status influences functional recovery in elderly individuals undergoing rehabilitation. While some studies indicate a positive relationship between good nutrition and improved recovery, others suggest that nutritional status affects baseline functional capacity more than the rate or degree of functional improvement during rehabilitation.
It is also important to recognize that most available studies have focused on patients admitted for rehabilitation after hip fractures or stroke, conditions often associated with sudden functional decline. To date, only one known study has investigated elderly patients undergoing rehabilitation following hip or knee replacement surgery due to degenerative osteoarthritis. Interestingly, that study found a statistically significant positive association between nutritional status and functional recovery specifically in this subgroup-an association not observed among patients recovering from hip fractures or stroke.
Nonetheless, the study had limitations: nutritional status was measured using only the Mini Nutritional Assessment-Short Form (MNA-SF), and evaluation occurred post-surgery, without preoperative or long-term follow-up data. Moreover, there are no available data on rehabilitation outcomes for shoulder osteoarthritis, an increasingly common condition among older adults that significantly impacts autonomy in daily living.
Given these gaps, the current research aims to determine whether malnutrition modifies the effects of VR-enhanced shoulder rehabilitation after elective surgery on functional recovery-that is, the ability to perform activities of daily living (ADLs)-in frail elderly patients. The hypothesis is that poor nutritional status could reduce the benefits of intensive, technology-based rehabilitation, while adequate nutrition may enhance neuroplasticity, muscle strength, and overall recovery potential.
This investigation seeks to clarify three main aspects:
- The prevalence and severity of malnutrition among elderly individuals undergoing elective surgery and subsequent VR-based rehabilitation.
- The interaction between nutritional status and functional outcomes, examining whether malnutrition acts as an effect modifier or mediator in recovery trajectories.
- The specific contribution of VR technology in improving rehabilitation adherence, motivation, and overall functional independence compared to conventional therapy.
By exploring the intersection between nutrition, aging, and digital rehabilitation, this research could help tailor multidisciplinary interventions that integrate nutritional management and advanced rehabilitation technologies. Such an approach may optimize recovery outcomes, reduce disability, and improve quality of life in frail older adults undergoing joint replacement or shoulder surgery due to osteoarthritis.
- Being tested
- Oculus Quest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus QuestDevice
Virtual reality device to simulate specific exercises aimed at rehabilitating patients with musculoskeletal shoulder pathologies.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality-augmented shoulder rehabilitation | Active comparator | Not described Receives: Device: Oculus Quest |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malnutrition as effect modifier of the impact of shoulder rehabiliation
"Absolute functional gain" (AFG), defined as the difference between the modified Barthel Index at the end of rehabilitation minus the modified Barthel Index before the rehabilitation (i.e. after surgery).
Measured: From enrollment to the end of rehabilitation treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Nov 2025
- Primary completion30 Jun 2026
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroplastyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudio Pedone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudio Pedone, Fondazione Policlinico Universitario Campus Bio-Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282561
- Sponsor's protocol ID
- 37.25_CET2_CBM_VIR
- Other IDs
- PNC0000007 - "Fit4MedRob"
- Acronym
- VIR
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nutritional Status in Functional Recovery of Older Adults Undergoing Virtual Reality-augmented Shoulder Rehabilitation (VIR)
- ClinicalTrials.gov ID
- NCT07282561
- Acronym / sponsor ID
- VIR / 37.25_CET2_CBM_VIR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Claudio PedoneUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 15 Dec 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.
Malnutrition is a clinical syndrome defined by involuntary weight loss and/or a persistent imbalance between nutritional needs and intake, leading to functional decline. Its prevalence is particularly high among older adults-affecting about 17% of community-dwelling elders, 30% of those in rehabilitation settings, and between 20% and 60% of individuals in acute care environments. Malnutrition is therefore a common yet often underrecognized factor influencing health outcomes in geriatric populations.
Osteoarthritis (OA), a degenerative joint disease marked by the deterioration of articular cartilage, results in pain and reduced mobility. It affects approximately 9.6% of men and 18% of women over the age of 60. With global life expectancy rising and populations aging, OA is projected to become the fourth leading cause of disability by 2025. Joint replacement surgery provides significant relief for severe cases, and consequently, an increasing number of adults-averaging around 70 years of age-undergo elective joint replacement surgeries followed by rehabilitation for degenerative OA.
In this context, Virtual Reality (VR) technology is emerging as an innovative tool in rehabilitation. VR can create engaging, interactive environments that promote motor relearning by allowing clinicians to adjust practice intensity and provide real-time feedback. This adaptability enables personalized rehabilitation programs designed to enhance patient motivation and adherence. Preliminary studies have shown encouraging results, suggesting that VR-assisted therapy may improve motor recovery and functional outcomes, and its use in rehabilitation settings is rapidly expanding.
Previous research has identified a strong link between malnutrition and sarcopenia (loss of muscle mass) and reduced physical performance. However, findings remain inconsistent regarding how nutritional status influences functional recovery in elderly individuals undergoing rehabilitation. While some studies indicate a positive relationship between good nutrition and improved recovery, others suggest that nutritional status affects baseline functional capacity more than the rate or degree of functional improvement during rehabilitation.
It is also important to recognize that most available studies have focused on patients admitted for rehabilitation after hip fractures or stroke, conditions often associated with sudden functional decline. To date, only one known study has investigated elderly patients undergoing rehabilitation following hip or knee replacement surgery due to degenerative osteoarthritis. Interestingly, that study found a statistically significant positive association between nutritional status and functional recovery specifically in this subgroup-an association not observed among patients recovering from hip fractures or stroke.
Nonetheless, the study had limitations: nutritional status was measured using only the Mini Nutritional Assessment-Short Form (MNA-SF), and evaluation occurred post-surgery, without preoperative or long-term follow-up data. Moreover, there are no available data on rehabilitation outcomes for shoulder osteoarthritis, an increasingly common condition among older adults that significantly impacts autonomy in daily living.
Given these gaps, the current research aims to determine whether malnutrition modifies the effects of VR-enhanced shoulder rehabilitation after elective surgery on functional recovery-that is, the ability to perform activities of daily living (ADLs)-in frail elderly patients. The hypothesis is that poor nutritional status could reduce the benefits of intensive, technology-based rehabilitation, while adequate nutrition may enhance neuroplasticity, muscle strength, and overall recovery potential.
This investigation seeks to clarify three main aspects:
- The prevalence and severity of malnutrition among elderly individuals undergoing elective surgery and subsequent VR-based rehabilitation.
- The interaction between nutritional status and functional outcomes, examining whether malnutrition acts as an effect modifier or mediator in recovery trajectories.
- The specific contribution of VR technology in improving rehabilitation adherence, motivation, and overall functional independence compared to conventional therapy.
By exploring the intersection between nutrition, aging, and digital rehabilitation, this research could help tailor multidisciplinary interventions that integrate nutritional management and advanced rehabilitation technologies. Such an approach may optimize recovery outcomes, reduce disability, and improve quality of life in frail older adults undergoing joint replacement or shoulder surgery due to osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality-augmented shoulder rehabilitation | Active comparator | Device: Oculus Quest |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 60 years old or older;
- Frailty defined according to the Clinical Frailty Scale (Cesari et al., 2018);
- Diagnosis of shoulder diseases with indication to elective surgery;
Key exclusion criteria (11 listed)
- Diagnosis of rheumatic diseases;
- Shoulder fracture;
- Actual SARS-CoV-2 infection;
- Diagnosis of active cancer;
- Any contraindication to oral feeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oculus QuestVirtual reality device to simulate specific exercises aimed at rehabilitating patients with musculoskeletal shoulder pathologies. | Device | Virtual reality-augmented shoulder rehabilitation |
Primary outcome
Malnutrition as effect modifier of the impact of shoulder rehabiliation
Time frame: From enrollment to the end of rehabilitation treatment at 4 weeks
"Absolute functional gain" (AFG), defined as the difference between the modified Barthel Index at the end of rehabilitation minus the modified Barthel Index before the rehabilitation (i.e. after surgery).
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 1 Sep 2026.
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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?
A study testing Oculus Quest in people with Shoulder Arthroplasty and Rehabilitation, run by Claudio Pedone 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 11 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. 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 Claudio Pedone, Prof. (+39 06 22 541 1349, c.pedone@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malnutrition as effect modifier of the impact of shoulder rehabiliation (time frame: From enrollment to the end of rehabilitation treatment at 4 weeks). 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 1 Sep 2026.