Virtual Rehabilitation for Spinal Fracture

(VIVA Trial)

Not currently recruiting at 5 trial locations

Overseen By Lora Giangregorio, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Waterloo

Disqualifiers: Cauda equina, Spinal cord injury, Traumatic fracture, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual rehabilitation program called VIVA for individuals with spine fractures from osteoporosis. The goal is to determine if VIVA can reduce pain and improve movement and quality of life. Participants will be divided into two groups: one starts the program immediately, and the other begins after 10 weeks. Those with a doctor-confirmed spine fracture in the last two years who can attend weekly online sessions may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance rehabilitation options for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual rehabilitation program is safe for people with spine fractures?

Research has shown that the Virtual Intervention for Vertebral Fractures (VIVA) program helps people with spine fractures. It focuses on pain management, safe movement, exercise, and nutrition. This online rehab program aims to ease recovery, particularly for those in areas with limited healthcare access.

Although specific safety data for VIVA is not yet available, the program is currently undergoing testing to assess the feasibility of a larger study. This indicates that the program is considered safe enough for this phase, though complete safety details remain unknown. However, virtual rehab programs generally pose low risk, as they do not involve medication or surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VIVA intervention for spinal fractures because it offers a fresh approach to rehabilitation using virtual technology. Unlike traditional treatments that rely heavily on physical therapy sessions, VIVA leverages virtual platforms to engage patients in rehabilitation exercises, potentially increasing accessibility and convenience. This innovative method focuses on behavior change techniques, encouraging patients to integrate these practices into their daily lives, which could lead to longer-lasting recovery benefits. By shifting rehabilitation to a virtual space, VIVA could make recovery more personalized and adaptable, addressing the diverse needs of patients more effectively than conventional methods.

What evidence suggests that the VIVA program is effective for spinal fracture rehabilitation?

Research has shown that virtual rehabilitation programs can aid recovery after spine fractures. The Virtual Intervention for Vertebral Fractures (VIVA) program is being tested in this trial to help individuals with spine fractures manage pain and enhance their physical abilities and overall quality of life. Participants in the immediate receipt group will receive the VIVA intervention during the first 8 weeks of the study, while those in the wait-list control and delayed receipt group will continue with their usual care for the first 10 weeks before receiving the VIVA intervention. This program includes exercises to improve movement and techniques to encourage positive behavior changes. Early results suggest that virtual programs like VIVA can be useful and accessible, especially for those in areas where in-person care is difficult to obtain. Although there is limited data on VIVA's effectiveness, similar programs have shown promise in addressing movement and pain issues. ^{1 2 3 5 6}

Who Is on the Research Team?

Lora Giangregorio, PhD

Principal Investigator

University of Waterloo

Are You a Good Fit for This Trial?

This trial is for individuals with spinal fractures, often related to osteoporosis. It's designed to help those who struggle with pain and mobility issues due to their fractures. The study aims at people who find it difficult to access rehabilitation services, possibly because they live in rural or remote areas.

Inclusion Criteria

Have access to internet and a smart device with a camera and microphone.

I am willing to join weekly online rehab sessions for 8 weeks.

I have had a spine fracture in the last 2 years, confirmed by an X-ray report.

Exclusion Criteria

I am already in a rehab program for spine fractures that includes exercise.

I have cauda equina syndrome or a spinal cord injury.

I had a major injury, an infection, or arthritis flare-up in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 months

Treatment

Participants receive the VIVA intervention, involving weekly 1:1 rehabilitation sessions for eight weeks

8 weeks

8 visits (virtual)

Behavior Change Techniques

Participants practice behavior change techniques following the initial intervention

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Intervention for Vertebral Fractures (VIVA)

Trial Overview The VIVA program, a virtual rehabilitation toolkit developed for spine fracture patients, is being tested. This pilot study will assess the feasibility of implementing VIVA across three provinces before expanding it further.

How Is the Trial Designed?

Group I: Wait-list control and delayed receipt group Experimental Treatment 1 Intervention

Participants in this group will continue with their usual care for the first 10 weeks of the study. At week 10, they will receive the same VIVA intervention.

Group II: Immediate receipt group Experimental Treatment 1 Intervention

Participants in this group will receive the VIVA intervention in the first 8 weeks of the study. After the 8-week period, participants will be asked to practice behaviour change techniques for the next 10 weeks.

Who Is Running the Clinical Trial?

University of Waterloo

Lead Sponsor

Trials

132

Recruited

221,000+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Unity Health

Collaborator

Trials

5

Recruited

22,900+

Arthritis Research Centre of Canada

Collaborator

Trials

16

Recruited

12,200+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

Published Research Related to This Trial

Vertebroplasty has been shown to provide no significant benefits over placebo for treating vertebral fractures, based on high-moderate quality evidence from five placebo-controlled trials.

There is a potential risk of serious adverse events associated with vertebroplasty, including symptomatic vertebral fractures and other complications, which suggests that patients should be fully informed about these risks before undergoing the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why we should stop performing vertebroplasties for osteoporotic spinal fractures. Buchbinder, R., Busija, L.[2020]

In a study of 515 patients who underwent percutaneous vertebral augmentation (PVA), 32.2% experienced subsequent vertebral fractures (SVF), highlighting the common risk of this complication in patients with low bone mineral density (BMD).

L1 trabecular attenuation measured by CT scans was found to be a significant predictor of SVF; specifically, an attenuation of 95 Hounsfield units or less indicated a higher risk of SVF, with a sensitivity of 70.5% and specificity of 79.9%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Use of CT Attenuation for the Prediction of Subsequent Vertebral Fracture in Patients with Osteoporosis. Zhang, SB., Xu, HW., Yi, YY., et al.[2021]

In a study of 182 osteoporotic patients treated with percutaneous vertebroplasty (PVP), 11.5% developed new vertebral compression fractures (VCFs) during an average follow-up of 26.4 months.

Higher body mass index (BMI) and a greater number of initial symptomatic fractures were significant risk factors for developing new VCFs after PVP, with the risk increasing 2.5 times for each additional initial fracture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors of new symptomatic vertebral compression fractures in osteoporotic patients undergone percutaneous vertebroplasty. Ren, HL., Jiang, JM., Chen, JT., et al.[2022]

A systematic review of 32 studies involving over 1,300 patients found that percutaneous vertebral augmentation (PVA) did not significantly increase the risk of subsequent clinical or radiological fractures compared to conservative treatment.

The analysis showed no significant differences in fracture rates between the PVA group and the conservative treatment group, suggesting that PVA is not associated with higher fracture risk at unoperated levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiological subsequent fractures after vertebral augmentation for treating osteoporotic vertebral compression fractures: a meta-analysis. Sun, HB., Jing, XS., Tang, H., et al.[2021]

In a study of 128 patients who underwent vertebral augmentation for osteoporotic fractures, key independent risk factors for subsequent refracture included previous fractures, cement leakage, and excessive correction of body angle (BA) beyond 3.45°.

The analysis revealed that patients in the refracture group had significantly higher rates of previous fractures and cement leakage, as well as greater postoperative lumbar lordosis, indicating that careful monitoring of these factors is crucial for preventing future fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of clinical, imaging, surgical risk factors for subsequent fracture following vertebral augmentation in osteoporotic patients. Chen, Z., Yao, Z., Wu, C., et al.[2022]

The VIVA virtual intervention, consisting of 7 one-on-one sessions with a physical therapist over 5 weeks, was well-received by participants, who reported improvements in pain and increased self-confidence.

Participants found VIVA easy to use and beneficial, with potential for significant improvements in their ability to plan and execute exercise routines, indicating its promise for nonpharmacological management of osteoporotic vertebral fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development, Acceptability, and Usability of a Virtual Intervention for Vertebral Fractures (VIVA). Ponzano, M., Tibert, N., Brien, S., et al.[2023]

Using a screw view model of navigation (SVMN) for unilateral percutaneous vertebroplasty (PVP) in a 59-year-old patient with a vertebral compression fracture resulted in a successful procedure with no complications over a 28-month follow-up period.

The SVMN technique not only improved the accuracy of needle placement but also reduced the operative time to 29.5 minutes and minimized radiation exposure compared to traditional fluoroscopy methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel computer navigation model guided unilateral percutaneous vertebroplasty for vertebral compression fracture: A case report. Xu, HT., Zheng, S., Kang, MY., et al.[2022]

A three-week rehabilitation program combining mechanotherapy, balance therapy, and specialized physiotherapy exercises significantly improved muscle strength and balance in 120 patients with osteoporotic vertebral fractures, indicating its efficacy in rehabilitation.

The program not only enhanced muscle function but also helped restore the center of gravity to a more physiological position, suggesting it effectively addresses both motor function and disability in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of back muscles training and balance therapy in rehabilitation of patients with osteoporotic vertebral fractures. Marchenkova, LA., Makarova, EV., Eryomushkin, MA., et al.[2022]

Virtual Fracture Clinics (VFCs) have been shown to be a safe and cost-effective alternative to traditional fracture clinics, improving patient care by standardizing treatment and reducing the need for outpatient appointments.

The implementation of VFCs in a District General Hospital led to a significant increase in new patient uptake from 0% to 56.1% within six months, demonstrating the effectiveness of a structured Quality Improvement approach involving careful planning and multidisciplinary feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adopting and sustaining a Virtual Fracture Clinic model in the District Hospital setting - a quality improvement approach. Logishetty, K.[2020]

Healthcare professionals (HCPs) view non-pharmacological treatments as beneficial for recovery from vertebral fractures, with treatment choices tailored to the fracture's acuity and individual patient needs.

While HCPs support the use of virtual care for managing vertebral fractures, they express concerns about patient access, costs, and the need for comprehensive assessments, indicating that further evaluation of this approach is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-pharmacological management of osteoporotic vertebral fractures: health-care professional perspectives and experiences. Tibert, N., Ponzano, M., Brien, S., et al.[2023]

Participants with osteoporotic vertebral fractures identified pain as the main barrier to recovery, significantly impacting their daily activities and overall well-being.

Non-pharmacological strategies like physiotherapy, education, and exercise were viewed as beneficial, but challenges in timely diagnosis and referral hindered access; participants also saw virtual rehabilitation as a promising alternative, despite concerns about technology and program customization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-pharmacological management of osteoporotic vertebral fractures: Patient perspectives and experiences. Tibert, N., Ponzano, M., Brien, S., et al.[2023]

Robot-assisted percutaneous vertebroplasty (PVP) significantly reduces operation time and radiation exposure compared to traditional freehand techniques, as shown in a study of 42 patients for each method.

The accuracy of the robot-assisted technique meets clinical requirements, and the learning curve for this method is short, indicating it can be quickly adopted by surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted percutaneous vertebroplasty for osteoporotic vertebral compression fractures: a retrospective matched-cohort study. Tan, L., Wen, B., Guo, Z., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40618179/

Virtual Intervention for Vertebral frActures (VIVA) The purpose of the study is to investigate the feasibility of a multicentre randomized controlled trial of an 8-week virtual rehabilitation intervention.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06650410

Virtual Intervention for Vertebral frActure: a Pilot, Feasibility ... As secondary outcomes, the research team will explore the effect of the intervention on physical function and balance, pain, fear of movement, falls, falls self ...

3. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-025-01665-x

Virtual Intervention for Vertebral frActures (VIVA): protocol for a ... The purpose of the study is to investigate the feasibility of a multicentre randomized controlled trial of an 8-week virtual rehabilitation intervention.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12228205/

Virtual Intervention for Vertebral frActures (VIVA) Secondary outcomes are guided by reach, effectiveness, adoption, implementation, and maintenance qualitative evaluation for systematic ...

5. arthritisresearch.ca arthritisresearch.ca/research/virtual-intervention-for-vertebral-fracture-viva-a-rehab-program-for-better-recovery-after-spine-fractures/

Virtual Intervention for Vertebral frActure (VIVA): A rehab ... The Virtual Intervention for Vertebral fracture (VIVA) is a virtual rehabilitation program designed to improve mobility and quality of life after spine ...

6. withpower.com withpower.com/trial/phase-spinal-fractures-10-2024-cb64e

Virtual Rehabilitation for Spinal Fracture (VIVA Trial) The VIVA medical study, being run by University of Waterloo, is evaluating whether Virtual Intervention for Vertebral Fractures (VIVA) will have tolerable ...