The Effect Spinal Bracing System on Gait in Adult Scoliosis Patients

Status unconfirmed · Not applicable

Conditions studied: Scoliosis

In brief

Degenerative adult scoliosis (ADS) results from age related changes leading to segmental instability, deformity and stenosis. Patients with scoliosis demonstrate an altered gait pattern.Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. Bracing has been found to reduce pain within a short time in ADS patients. A new brace has recently become available, the Peak™ Scoliosis Brace (Aspen Medical Products), designed to alleviate pain in adult patients with chronic pain secondary to scoliosis. The purpose of this study is to investigate the impact of spinal bracing using Peak™ Scoliosis Brace on pain and lower extremities kinematics of gait.

Key facts

Study ID

NCT03572855

Run by

Texas Back Institute

People needed

30

Starts

2018-06-15

Expected to finish

2019-09-01

Last updated by the study team

2018-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 30- 75 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
• Able to ambulate without assistance and stand without assistance with their 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-treatment 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
• 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

Full record on ClinicalTrials.gov

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