Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Adult spinal deformity surgery patients Adults diagnosed with spinal deformity and who are undergoing spinal realignment fusion surgery.
  • Procedure: Spinal Fusion
    Realignment and fusion of adult spinal deformity
Asymptomatic adult controls Adults with no history of spinal deformity or previous spinal fusions.
  • Other: No intervention
    No intervention for control group.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Damon Mar
913-574-2310
dmar@kumc.edu

Detailed Description

While functional balance metrics are increasingly being recognized as important objective indicators of disability associated with ASD, there is a need for a refinement of existing balance assessments to provide more clinically relevant information to better assist in the development of treatment strategies and in assessing treatment outcomes. The use of force plates and wearable sensors is growing among spine surgeons during patient assessments, so it is pertinent to refine test protocols that utilize this equipment rather than propose new methods with unproven or unfamiliar equipment. Standardization of a test protocol that utilizes existing technology to provide a more robust assessment of ASD patient balance performance will help spine surgeons better understand the characteristics of balance that are most affected by each patient's unique deformity and incorporate them into planning treatment strategies. Additionally, demonstration of the time requirements for this evaluation protocol is a critical step in establishing clinical relevance and efficacy for ASD patient care. Data generated from this study will serve as important pilot data for additional studies focusing on the efficacy of the functional reach test to provide clinically relevant information on limits of functional balance among ASD patients. Information will provide guidance for both clinical decision-making and for objective techniques to assess postural balance of ASD patients. The objectives of this research are as follows: 1) develop a clinically relevant protocol for assessing functional balance limits for ASD patients utilizing the functional reach test, 2) provide estimates of time requirements to conduct balance assessments in a spine clinic setting, and 3) provide preliminary data on postural balance limits of ASD patients and compare to them to matched asymptomatic controls.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.