Adolescent Idiopathic Scoliosis Clinical Trial
Official title:
Pilot Trial Green Sun Medical Dynamic Brace
Verified date | November 2023 |
Source | Children's Hospital Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Green Sun Medical Dynamic Brace (GSM) brace was developed as an alternative to rigid thoracolumbosacral orthoses (TLSOs, braces) commonly used to prevent continued curve progression in patients with adolescent idiopathic scoliosis (AIS). The brace applies corrective forces to the muscular and bony structures of the spine while preserving range of motion (ROM). The innovative design of this brace should provide an equivalent degree of correction of the scoliotic curvature as a rigid TLSO, with increased acceptability to the patient via improved comfort and spinal/chest wall mobility. Increased acceptability promotes increased adherence to treatment. This is a pilot study to collect preliminary short-term data concerning the safety and performance of the GSM brace in a sample of subjects with AIS who are currently being treated with a TLSO. The study will use clinical exams, x-rays, monitoring equipment, and questionnaires to primarily assess safety and performance. Secondary endpoints include spinal ROM and lung vital capacity assessment, as well as data validation. The study involves 3 visits, a performance check phone call, and 4 follow up calls over a four month span. This is a pilot study and no formal hypothesis testing will be done. Descriptive statistics of selected variables will be calculated.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 10 Years to 15 Years |
Eligibility | Inclusion Criteria: - Diagnosis of AIS - Current treatment with a TLSO, of =5 months' duration - Existing 3D surface scan of torso and out-of-brace x-ray within the past 6 months. If no scan exists, patient must be willing to undergo a scan to allow fabrication of the GSM brace. - One curve apex below T7 - Female sex (85% of the AIS population is female) - Ability to read and write English - Age 10-15 years Exclusion Criteria: - Parents/patients who decline participation and/or do not sign the consent/assent documents - Pregnant women - Patients who are unwilling or unable to return for follow-up visits - Patients who are unable to read and write in English. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cobb Angle (Visit 2) | Visit 2 GSM in-brace Cobb angle compared to that in the TLSO at baseline | Visit 2 (1 week after baseline) | |
Primary | Cobb Angle (Visit 3) | 2. Visit 3 out of brace Cobb angle compared to measurements from the most recent out of brace radiograph | Visit 3 (3 months after Baseline) | |
Primary | GSM Brace wear time | 3. Average hours of GSM brace wear per day over the 3 month trial period (temperature monitor data) | Visit 3 (3 months after baseline) | |
Primary | Brace questionnaire | Change in scores on the Brace Questionnaire from baseline to the 3 month Visit.
Brace questionnaire minimum/maximum values: 0-34 min/max values; lower score is defined as positive feeling/outcome of brace wear while higher score shows negative feeling/outcome towards brace. |
Visit 3 (3 months after baseline) | |
Primary | Italian Spine Youth Quality of Life | Change in scores of the Italian Spine Youth Quality of Life (ISYQOL) from baseline to the 3 month Visit.
ISYQOL minimum/maximum values: 1-10 min/max values; lower value is defined as disliking brace while higher value is defined as "loving" brace. |
Visit 3 (3 months after baseline) | |
Secondary | % Full Vital Capacity Lung Function Test | Vital capacity relative to that obtained in the TLSO at Visit 1 and compared between the TSLO Rigid brace vs. Green Sun Medical Brace.
This will be done via pulmonary function test (% relative to standard norms). Full vital capacity (FVC) function test will be done and assessed at the baseline visit. |
Visit 1 (baseline) | |
Secondary | Range of Motion (flexion, extension, side bend) | Range of motion testing involves forward bending (flexion), backwards bending (Extension), side bending on both right and left while wearing both the TLSO rigid brace vs. Green Sun Medical brace. Units will be in cm. Measurement will be done from the floor to the tip of the finger as the subject bends over. | Visit 1 (baseline) | |
Secondary | Accelerometer data | Accelerometer data (obtained from an embedded sensor in the GSM brace) as an estimate of the average hours of wear per day (to be validated by comparison with temperature monitor data) | Visit 3 (3 months after baseline) |
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