Effect of Adult Spinal Deformity Surgery on Functional Reach

NCT06258161 | Recruiting

• 1 other identifier: STUDY00150790
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Balance

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Patient reported pain level

  Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups

• Patient reported disability

  Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups

• Timed up and go test

  Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups

Study Arms (2)

Adult spinal deformity surgery patients

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

Procedure: Spinal Fusion

Asymptomatic adult controls

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

Other: No intervention

Interventions

Spinal Fusion PROCEDURE

Realignment and fusion of adult spinal deformity

Adult spinal deformity surgery patients

No intervention OTHER

No intervention for control group.

Asymptomatic adult controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Scoliosis Research Society: collaborator
• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Scoliosis

Interventions

Spinal Fusion

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthrodesis; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Damon Mar

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damon Mar

CONTACT

913-574-2310; dmar@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Instructor

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 14, 2024
• Study Start: June 8, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (1)