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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Scoliosis; Scoliosis Kyphosis
• Intervention / Treatment: Procedure: Spinal Fusion

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Damon Mar; Phone Number: 913-574-2310; Email: dmar@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The adult spinal deformity (ASD) group will consist of adults with a diagnosis of scoliosis who are eligible for spinal deformity correcting surgery at the University of Kansas Medical Center.

The asymptomatic control group will consist of adults who do not have any spinal diagnoses, have not have prior spinal fusions, and do not have any other conditions that affect their ability to perform the study activities.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional reach distance	The distance a participant can reach forward (in cm), to the side, and 45 degrees to the side with each arm	Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Center of pressure sway range	The range (in mm) that the participant's center of pressure moves in sagittal and coronal plane directions during the functional reach tests	Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Center of pressure velocity	The maximum and average velocity (in m/s) that the participant's center of pressure reaches during the functional reach tests	Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Center of pressure excursion	The summation of the distance (in mm) that the participant's center of pressure moves during the functional reach tests	Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported pain level	Questionnaires assessing level of pain (0-10 on the numeric rating scale) for the mid-back, low-back, and both legs	Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Patient reported disability	A questionnaire called the Oswestry disability index (ODI) that assesses level of disability in performing activities of daily living	Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Timed up and go test	The time is takes to rise from a chair, walked forward 10 feet, turn around, and then sit back down	Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Scoliosis Research Society
• Investigators: Principal Investigator: Damon Mar, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Estimated): February 14, 2024

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Balance
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Kyphosis
• Other Study ID Numbers: STUDY00150790

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data from this study may be shared with other researchers in the future, but the type of data and the method of sharing has not been determined yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No