NCT06258161

Effect of Adult Spinal Deformity Surgery on Functional Reach

Functional Reach Test as a Clinical Tool for Assessing Postural Balance Limits Among Adult Spinal Deformity Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Scoliosis
• Scoliosis Kyphosis

Interventions

Type	Name	Description
PROCEDURE	Spinal Fusion	Realignment and fusion of adult spinal deformity
OTHER	No intervention	No intervention for control group.

Timeline

• Start date: 2024-06-08
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2024-02-14
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States