Gait and Balance in Thoracolumbar Spinal Deformity
Status unconfirmed · Not applicable
Conditions studied: Spinal Curvatures
In brief
Surgical intervention may provide pain relief and improvement in function but one area of significant clinical interest is the restoration/improvement in gait and functional balance. Based on the investigators knowledge, there is limited literature on biomechanics and neuromuscular control of the lower extremities and spine as assessed by objective gait analysis and balance strategies in adult degenerative scoliosis patients, pre and post surgical intervention. The purpose of this study is to determine the impact of spinal deformity on the biomechanics and neuromuscular control of the lower and upper extremities, and also investigate the impact of surgery on these functions as evaluated by gait and balance analyses using dynamic EMG, video motion capture and force plate analysis and also to compare these patients with healthy controls to better evaluate the extent of limitations before and after surgery.
Key facts
- Study ID
- NCT02761265
- Run by
- Texas Back Institute
- People needed
- 100
- Starts
- 2016-03-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2016-05-04
Who can join
Age: 30 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 30 years and older
- Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater
- Instrumentation to be used at 4 or more levels
- Able to ambulate without assistance and stand without assistance with participant eyes open for a minimum of 10 seconds
- Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-operative follow-up
You may not qualify if…
- History of prior attempt at fusion (successful or not) at the indicated levels, (history of one level fusion is not an exclusion)
- Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
- BMI higher than 35
- Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
- Usage of blood thinners
- Major trauma to the pelvis
- Pregnant or wishing to become pregnant during the study
Where it is running
- Texas Back Institute — Plano, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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