Recruiting

Balance Assessment

Sponsor:

University of Kansas Medical Center

Code:

NCT06258161

Conditions

Scoliosis

Scoliosis Kyphosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Spinal Fusion

No intervention

Study Details

Brief summary:

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.

Conditions

Scoliosis

Scoliosis Kyphosis

Study ID

NCT06258161

Start date

Jun 8, 2024

Status verified date

Apr, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Adult spinal deformity surgery patients

Adults diagnosed with spinal deformity and who are undergoing spinal realignment fusion surgery.

Asymptomatic adult controls

Adults with no history of spinal deformity or previous spinal fusions.

Interventions

Spinal Fusion

Realignment and fusion of adult spinal deformity

No intervention

No intervention for control group.

Primary outcome measure

  • Functional reach distance [ Time Frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups ]
  • Center of pressure sway range [ Time Frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups ]
  • Center of pressure velocity [ Time Frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups ]
  • Center of pressure excursion [ Time Frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups ]

Central Contacts and Locations

Central contacts

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • Balance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-05-06.