Scoliosis Clinical Trial
Official title:
Functional Reach Test as a Clinical Tool for Assessing Postural Balance Limits Among Adult Spinal Deformity Patients
NCT number | NCT06258161 |
Other study ID # | STUDY00150790 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2024 |
Est. completion date | June 2026 |
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Kansas Medical Center | Scoliosis Research Society |
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 |
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