University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Location status: Recruiting
NCT Number: NCT06258161
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Kansas City, Kansas, 66160, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Adult Spinal Deformity Patient Inclusion Criteria:
Adult Spinal Deformity Patient Exclusion Criteria:
Asymptomatic Control Participant Inclusion Criteria:
Asymptomatic Control Participant Exclusion Criteria:
Realignment and fusion of adult spinal deformity
No intervention for control group.
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The distance a participant can reach forward (in cm), to the side, and 45 degrees to the side with each arm
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The range (in mm) that the participant's center of pressure moves in sagittal and coronal plane directions during the functional reach tests
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The maximum and average velocity (in m/s) that the participant's center of pressure reaches during the functional reach tests
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The summation of the distance (in mm) that the participant's center of pressure moves during the functional reach tests
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Questionnaires assessing level of pain (0-10 on the numeric rating scale) for the mid-back, low-back, and both legs
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
A questionnaire called the Oswestry disability index (ODI) that assesses level of disability in performing activities of daily living
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The time is takes to rise from a chair, walked forward 10 feet, turn around, and then sit back down
Contact information is provided by the study sponsor or research team.
University of Kansas Medical Center
Other
Functional Reach Test as a Clinical Tool for Assessing Postural Balance Limits Among Adult Spinal Deformity Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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