NCT06258161 · University of Kansas Medical Center
Effect of Adult Spinal Deformity Surgery on Functional Reach
What this study is about
Adult spinal deformity (ASD) is a common spinal condition that often impacts an individual's ability to stand and maintain an upright posture. Poor balance often limits an individual's ability to perform basic activities of daily life (ADL) and can lead to disability. Current considerations of correcting ASD to improve balance focus on the amount of sway that one exhibits during normal standing.
View original scientific description
Adult spinal deformity (ASD) is a common spinal condition that often impacts an individual's ability to stand and maintain an upright posture. Poor balance often limits an individual's ability to perform basic activities of daily life (ADL) and can lead to disability. Current considerations of correcting ASD to improve balance focus on the amount of sway that one exhibits during normal standing. However, current tests do not provide insight into the limits of balance during normal ADL. The goal of this research is to develop a new balance assessment that includes a functional reach test (FRT) to provide numerical data on the limits of one's ability to maintain balance. The study will include both ASD patients and matched healthy adults and will compare postural sway measures between them. Wearable motion tracking sensors and a force plate will be used to monitor body movement and changes in the center of pressure under foot during normal standing and during a FRT. Data from this study will inform spine surgeons of ASD patient's risk of balance loss in daily life and enable further research on the effects of surgical techniques to restore balance among ASD surgery patients.
Interventions
PROCEDURE
Spinal Fusion
Realignment and fusion of adult spinal deformity
OTHER
No intervention
No intervention for control group.
Primary outcome measures
Functional reach distance
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The distance a participant can reach forward (in cm), to the side, and 45 degrees to the side with each arm
Center of pressure sway range
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The range (in mm) that the participant's center of pressure moves in sagittal and coronal plane directions during the functional reach tests
Center of pressure velocity
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The maximum and average velocity (in m/s) that the participant's center of pressure reaches during the functional reach tests
Center of pressure excursion
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The summation of the distance (in mm) that the participant's center of pressure moves during the functional reach tests
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Kansas City, Kansas
Collaborators
Scoliosis Research Society
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations