Effect of Adult Spinal Deformity Surgery on Functional Reach

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258161
• Other study ID #: STUDY00150790
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: June 2026

Study information

• Verified date: February 2024
• Source: University of Kansas Medical Center
• Contact: Damon Mar
• Phone: 913-574-2310
• Email: dmar[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kyphosis
• Scoliosis

Intervention

Procedure:
• Spinal Fusion
Realignment and fusion of adult spinal deformity

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Scoliosis Research Society

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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