50 Participants Needed

Motion Analysis for Spinal Deformity

KS
RR
Overseen ByRebecca Ranfranz
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand how spinal deformities affect movement and stability in daily life. Researchers will use a small device called a triaxial accelerometer (a motion-sensing device) to track participants' activity both in a lab and during their normal routines. It suits those diagnosed with degenerative thoracolumbar (lower/middle back) deformity who are scheduled for corrective surgery involving a specific type of spinal fusion. Participants must be able to return to the Mayo Clinic for follow-up visits.

As an unphased trial, this study allows participants to contribute to valuable research that may enhance future treatment strategies.

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. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this motion analysis testing is safe for spinal deformity patients?

Research has shown that triaxial accelerometers are safe and comfortable for measuring movement and posture. One study used these devices to assess walking and balance after spinal surgery, finding that they accurately tracked changes without causing harm. Another study demonstrated that triaxial accelerometers effectively detect posture changes with minimal error. This consistency and accuracy make them reliable for monitoring movement in patients with spinal issues.12345

Why are researchers excited about this trial?

Researchers are excited about the Motion Analysis for Spinal Deformity trial because it uses a triaxial accelerometer to assess how people with spinal deformities move in their everyday lives. Unlike traditional methods that rely on static X-rays or MRI scans, this approach captures real-time movement data, providing a more dynamic and comprehensive view of how the spine functions during daily activities. By understanding these movement patterns, researchers hope to develop more personalized and effective treatment plans that go beyond the limitations of standard imaging techniques.

What evidence suggests that this motion analysis technique is effective for assessing spinal deformity?

Research shows that special devices called triaxial accelerometers effectively track movement changes in patients with spinal issues. In this trial, participants will undergo an Activity Monitor Assessment using these accelerometers to evaluate their movement. Studies have found that these devices accurately measure walking and movement after spinal surgery. For patients with scoliosis, accelerometers help identify irregularities in movement patterns. This information suggests that triaxial accelerometers provide important insights into how spinal problems affect daily life, making them a helpful tool for monitoring progress and treatment outcomes.14678

Who Is on the Research Team?

BE

Benjamin Elder, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults who are scheduled to have spinal deformity correction surgery involving at least a 4-level fusion with pelvic fixation, specifically under Dr. Elder or Dr. Fogelson, and diagnosed with degenerative thoracolumbar deformity.

Inclusion Criteria

I have been diagnosed with a spine deformity in my upper or lower back.
I am scheduled for spine surgery with Dr. Elder or Dr. Fogelson, involving a large area and pelvis attachment.

Exclusion Criteria

Unable to return to Mayo Clinic for follow-up evaluation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Assessment

Participants undergo spinal deformity surgery and initial motion analysis testing

Baseline
1 visit (in-person)

Post-Surgery Assessment

Participants are assessed for changes in function, gait, and trunk stability using motion analysis and accelerometers

6-12 weeks
1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term changes in function, gait, and trunk stability

1 year
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Triaxial accelerometer
Trial Overview The study is using motion analysis testing and triaxial accelerometers to measure the functional activity and stability of patients after they undergo spinal deformity surgery.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Activity Monitor AssessmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Use of a Triaxial Accelerometer to Measure Changes in Gait ...Use of a triaxial accelerometer to measure changes in gait sway and related motor function after corrective spinal fusion surgery for adult spinal deformity.
Wearable accelerometers reveal objective assessment of ...The results indicate significant issues in both gait regularity and symmetry for patients with Lenk1 and Lenk5 types of idiopathic scoliosis, ...
On mobility and gait in scoliosis patients: a comparison of ...A preliminary evaluation on the clinical effectiveness of 3D-printed braces showed comparable compliance and quality of life between AIS ...
A smart point-of-care compliance monitoring solution for ...(2014) reported that patients who wore the brace for 0–6 h daily had a success rate of 42%, whereas patients who wore the brace for at least 12.9 h had success ...
Protective and risk physical activities for adolescent ...Those regularly engaging in moderate-to-vigorous physical activity at 11 years were 30% less likely to develop scoliosis. Chopra et al. (25) ...
Detecting spinal posture change in sitting positions with tri- ...Conclusions. The precision and reliability of the tri-axial accelerometers was demonstrated to be good enough for detecting posture change in sitting positions.
Validity and reliability of triaxial accelerometers for ...The angular error of the system is small (1.3 degrees), the reproducibility is high (0.2 degrees), and the inherent angular noise is small (0.04 ...
(PDF) Wearable Devices in Scoliosis Treatment: A Scoping ...This manuscript provides a scoping review of the classification and application of wearable devices and the role of artificial intelligence (AI) ...
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