Pilot Trial Green Sun Medical Dynamic Brace
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Cobb Angle (Visit 3)
研究概览
简要总结
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.
详细描述
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 orthosis is prefabricated and adjusted for each patient. A series of semi-rigid segments encircle the patient's torso in close contact and are joined by a structure of flexible elements. These flexible (or elastic) elements generate stabilizing forces, providing the necessary immobilization while allowing relative motion of the semi-rigid segments. To date, this brace has been tested in the lab on healthy volunteers.
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. Given the strong research evidence that bracing effectiveness is a function of correction and adherence, there is reason to believe that a future pivotal study of the GSM brace could demonstrate superior effectiveness to rigid TLSO designs.
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.
In addition, this pilot study to provide "proof of concept" data which will inform further refinements of the GSM brace and support the development of a subsequent pivotal multicenter clinical trial.
Our primary aims involve safety and performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Cobb Angle (Visit 3)
时间窗: Visit 3 (3 months after Baseline)
2. Visit 3 out of brace Cobb angle compared to measurements from the most recent out of brace radiograph
GSM Brace wear time
时间窗: Visit 3 (3 months after baseline)
3. Average hours of GSM brace wear per day over the 3 month trial period (temperature monitor data)
Cobb Angle (Visit 2)
时间窗: Visit 2 (1 week after baseline)
Visit 2 GSM in-brace Cobb angle compared to that in the TLSO at baseline
Brace questionnaire
时间窗: Visit 3 (3 months after baseline)
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.
Italian Spine Youth Quality of Life
时间窗: Visit 3 (3 months after baseline)
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.
次要结局
- Accelerometer data(Visit 3 (3 months after baseline))
- % Full Vital Capacity Lung Function Test(Visit 1 (baseline))
- Range of Motion (flexion, extension, side bend)(Visit 1 (baseline))
研究者
Kenneth Illingworth
Principal Investigator
Children's Hospital Los Angeles