Scoliosis Clinical Trial
Official title:
The Effect of Peak Scoliosis Spinal Bracing System on Gait and Pain Level in Adult Scoliosis Patients
Verified date | August 2018 |
Source | Texas Back Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | September 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 30- 75 years and older 2. Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater 3. Able to ambulate without assistance and stand without assistance with their eyes open for a minimum of 10 seconds 4. 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 Exclusion Criteria: 1. History of prior attempt at fusion (successful or not) at the indicated levels, (history of one level fusion is not an exclusion) 2. Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion) 3. BMI higher than 35 4. Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance 5. Major trauma to the pelvis 6. Pregnant or wishing to become pregnant during the study |
Country | Name | City | State |
---|---|---|---|
United States | Texas Back Institute | Plano | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Back Institute | Aspen Medical Products |
United States,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kinematic Variables Change assessed with human motion capture system | 3-Dimensional Range of Motion (ROM) during the stance and swing phase of the spine, pelvis, hip, knee, ankle, shoulder, and elbow joint angles along with center of mass and head sway and displacement | Baseline; 45 minutes and 2 moths after bracing | |
Secondary | Spatio-Temporal Variables Change assessed with human motion capture system | Walking speed | Baseline; 45 minutes and 2 moths after bracing | |
Secondary | Patient Self-Reported Outcome Assessments Change - Visual analog scale (VAS) | VAS for lower back pain, neck and arm pain, and leg pain. Scale range from 0 (no pain) - 10 (most pain) | Baseline; 45 minutes and 2 moths after bracing | |
Secondary | Patient Self-Reported Outcome Assessments Change - Oswestry Disability Index (ODI, version 2.1.a). | Scale range from 0 (no pain) - 10 (most pain) | Baseline; 45 minutes and 2 moths after bracing | |
Secondary | Patient Self-Reported Outcome Assessments Change - Scoliosis Research Society (SRS22) | The SRS-22 Patient Questionnaire has become the most widely used patient-reported outcome instrument in the clinical evaluation of patients with idiopathic scoliosis. | Baseline; 45 minutes and 2 moths after bracing | |
Secondary | Patient Self-Reported Outcome Assessments Change - Tampa Scale for Kinesiophobia (TSK). | TSK is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. | Baseline; 45 minutes and 2 moths after bracing | |
Secondary | Patient Self-Reported Outcome Assessments Change - Fear Avoidance Beliefs Questionnaire (FABQ) | The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability | Baseline; 45 minutes and 2 moths after bracing |
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