Assessing balance in adults with spinal deformities
Functional Reach Test as a Clinical Tool for Assessing Postural Balance Limits Among Adult Spinal Deformity Patients
This study is testing a new way to measure balance in adults with spinal deformities after surgery to see how it compares to healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06258161 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the impact of adult spinal deformity (ASD) surgery on functional balance using a new assessment method that includes a functional reach test (FRT). The study will compare balance metrics between ASD patients and healthy adults using wearable motion tracking sensors and force plates to measure postural sway. By refining existing balance assessments, the research seeks to provide clinically relevant data that can inform treatment strategies and outcomes for ASD patients. The findings will also serve as pilot data for future studies on balance assessment in this population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 diagnosed with adult spinal deformity who are indicated for corrective surgery and can perform functional activities independently.
Not a fit: Patients with spinal tumors, trauma, or infections, as well as those unable to attend follow-up evaluations, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved balance assessments that enhance treatment planning and outcomes for patients with adult spinal deformities.
How similar studies have performed: While there is growing interest in using technology for balance assessments in spinal surgery, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Adult Spinal Deformity Patient Inclusion Criteria: * Adults over the age of 18 * Diagnosed with adult spinal deformity according to the SRS-Schwab Adult Spinal Deformity Classification System * Indicated for deformity corrective surgery including multilevel spinal fusion of three or more levels * Lowest instrumented level includes S1 or pelvic fixation * Able to perform functional activities without the use of any assistance or support * devices Adult Spinal Deformity Patient Exclusion Criteria: * Indicated for spinal fusion due to spinal tumor, trauma, or infection * ASD patients who do not plan to be available for all follow-up evaluations at our institution * Pregnancy during any time point within the participation duration Asymptomatic Control Participant Inclusion Criteria: * Adults over the age of 18 * No current or prior spine pathology or surgery * Able to perform the functional activities without the use of any assistance or support devices Asymptomatic Control Participant Exclusion Criteria: * Any current or prior spine or lower extremity pathology or surgery that impacts the subject's ability to perform the functional activities * Pregnancy at the time of the evaluation
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Damon Mar — University of Kansas Medical Center
- Study coordinator: Damon Mar
- Email: dmar@kumc.edu
- Phone: 913-574-2310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.