32 Participants Needed

Virtual Rehabilitation for Spinal Fracture

(VIVA Trial)

Recruiting at 3 trial locations
LG
Overseen ByLora Giangregorio, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Waterloo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Spine fractures are the most common fracture due to osteoporosis. They happen during falls or activities of daily life, like bending to tie shoes. Fractures of the spine can result in pain, which can sometimes last for a long time. Spine fractures can affect breathing, appetite, digestion, and mobility, and can restrict or modify people's work or daily activities. There are no standard rehabilitation programs after spine fracture, and patients often have to pay for rehabilitation. Rehabilitation can be hard to access, especially in rural or remote locations. It can be hard to find health care or rehabilitation providers who specialize in treating spine fractures. After reviewing research and consulting patients and health care providers to understand their experiences with spine fracture rehabilitation, the research team developed a toolkit for a virtual rehabilitation program for people with spine fractures, called VIVA. The research team wants to submit a grant for a clinical trial to implement VIVA in five provinces and determine if VIVA reduces pain and improves physical functioning and quality of life, and if the benefits outweigh the costs. Before this, the team proposes to do a pilot study to test how feasible it is to do a study of VIVA in three provinces.

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 data supports the effectiveness of the treatment Virtual Intervention for Vertebral Fractures (VIVA)?

The Virtual Fracture Clinics (VFCs) model, which is similar to VIVA, has been shown to be a safe, cost-effective, and efficient way to manage musculoskeletal injuries, improving patient care by standardizing treatment and reducing the need for outpatient visits.12345

Is virtual rehabilitation for spinal fracture safe for humans?

The research does not provide specific safety data for virtual rehabilitation for spinal fractures, but it highlights potential risks associated with similar treatments like vertebroplasty, which can include serious complications such as spinal cord compression and infection.678910

How is the VIVA treatment for spinal fractures different from other treatments?

The VIVA treatment is unique because it uses a virtual intervention to follow international recommendations for non-drug management of spinal fractures, focusing on rehabilitation through virtual care, which is different from traditional physical therapies or surgical options.1231112

Research Team

LG

Lora Giangregorio, PhD

Principal Investigator

University of Waterloo

Eligibility Criteria

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

I am willing to join weekly online rehab sessions for 8 weeks.
Have access to internet and a smart device with a camera and microphone.
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.
See 2 more

Timeline

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

Treatment Details

Interventions

  • Virtual Intervention for Vertebral Fractures (VIVA)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Wait-list control and delayed receipt groupExperimental Treatment1 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 groupExperimental Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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.
Development, Acceptability, and Usability of a Virtual Intervention for Vertebral Fractures (VIVA).Ponzano, M., Tibert, N., Brien, S., et al.[2023]
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.
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.
Non-pharmacological management of osteoporotic vertebral fractures: Patient perspectives and experiences.Tibert, N., Ponzano, M., Brien, S., et al.[2023]

References

Development, Acceptability, and Usability of a Virtual Intervention for Vertebral Fractures (VIVA). [2023]
Non-pharmacological management of osteoporotic vertebral fractures: health-care professional perspectives and experiences. [2023]
Non-pharmacological management of osteoporotic vertebral fractures: Patient perspectives and experiences. [2023]
Adopting and sustaining a Virtual Fracture Clinic model in the District Hospital setting - a quality improvement approach. [2020]
Robot-assisted percutaneous vertebroplasty for osteoporotic vertebral compression fractures: a retrospective matched-cohort study. [2023]
Clinical and radiological subsequent fractures after vertebral augmentation for treating osteoporotic vertebral compression fractures: a meta-analysis. [2021]
Why we should stop performing vertebroplasties for osteoporotic spinal fractures. [2020]
Evaluation of the Use of CT Attenuation for the Prediction of Subsequent Vertebral Fracture in Patients with Osteoporosis. [2021]
Risk factors of new symptomatic vertebral compression fractures in osteoporotic patients undergone percutaneous vertebroplasty. [2022]
Assessment of clinical, imaging, surgical risk factors for subsequent fracture following vertebral augmentation in osteoporotic patients. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
A novel computer navigation model guided unilateral percutaneous vertebroplasty for vertebral compression fracture: A case report. [2022]
Efficiency of back muscles training and balance therapy in rehabilitation of patients with osteoporotic vertebral fractures. [2022]