Green Sun Medical Dynamic Scoliosis Brace
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Acceptable GSM In-Brace Correction
研究概览
简要总结
This is a pilot study to collect preliminary short-term data concerning the safety and performance of the Green Sun Dynamic brace in a sample of subjects with adolescent idiopathic scoliosis who are currently being treated with a TLSO.
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.
This study will recruit patients currently using a TLSO and compare the curve correction achieved in the GSM brace to that in their current brace. After 3 months in the GSM brace, the out-of-brace Cobb angle will be measured and compared to that at enrollment. Safety will be continually assessed. Brace-related quality of life (comfort, stress, interference with activities) will be self-reported. Adherence to the brace prescription will be measured using an in-brace temperature monitor.
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
盲法说明
The outcomes assessor will be blinded to brace type when measuring the out-of-brace x-ray.
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
- •One curve apex below T7
- •Ability to read and write English
- •Age 10-15 years
排除标准
- •1) Parents/patients who decline participation and/or do not sign the consent/assent documents 2) Pregnant women 3) Unwilling or unable to return for follow-up visits
结局指标
主要结局
Percentage of Participants With Acceptable GSM In-Brace Correction
时间窗: Baseline (TLSO measurement) to GSM brace delivery (GSM measurement) within 60 days
Acceptable GSM in-brace correction was defined as a difference of 10 degrees or less between the TLSO and GSM in-brace Cobb angles.
Unanticipated Adverse Events
时间窗: Up to 1 year
Unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues
Percentage of Participants With Curve Stability or Progression at 3-month Follow-up
时间窗: Baseline to ~3 mo Follow-up
Curve stability is defined as progression of 10 degrees or less between the Cobb angle at baseline and at follow-up after GSM wear (Baseline Cobb angle minus follow-up Cobb angle).
次要结局
- Change in Brace-related Quality of Life Scores (Brace Questionnaire)(Baseline to Visit 3 (3-4 months post-baseline))
- Change in Quality of Life Scores(Baseline to Visit 3 (3-4 months post-baseline))
- Difference in Vital Capacity Measured in TLSO and GSM Brace(Baseline)