Pilot Investigation of a Thoracolumbar Brace for Individuals With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Postural Alignment - Neck Position
研究概览
简要总结
This pilot study looked to see if a new brace would change the way people with Parkinson's Disease positioned their bodies. It also gathered information on the experience of wearing the brace.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-80 years of age
- •Diagnosed with Parkinson's Disease
- •Participant self-reports mild difficulty with posture
- •Independent in ambulation without an assistive device (i.e., no walker or cane)
- •Able to give consent determined via telephone screen assessment or at minimum can follow simple directions
- •Able to tolerate 5 minutes of standing or walking at a time per self-report
排除标准
- •Rigid or fixed spine, as determined by self-report and use of thoracolumbar flexibility screen
- •Symptoms present before the age of 50
- •Other neurologic diagnosis, as determined by self-report
- •Spinal surgery
- •Lives in a nursing home or skilled facility
- •Uncorrected vision loss
- •Skin that is sensitive to tape or extremely fragile
- •Recent surgery (within the last 3 months) that affects mobility, as determined by self-report
- •Chest pain at rest or with activity per self report
- •Shortness of breath with daily activity per self report
- •Severe orthostatic hypotension assessed during in-person screen with sitting and standing blood pressure, evidenced by a 20-point drop in systolic blood pressure or 10-point drop in diastolic blood pressure and symptoms (e.g., dizziness) that don't resolve in 5 minutes.
- •High blood pressure 180/110 resting or systolic blood pressure <90 mmHG
- •Resting heart rate > 100 bpm or <50 bpm
- •Waist circumference < 31" or > 51" that would prevent proper fitting of CALIBRACE.
结局指标
主要结局
Postural Alignment - Neck Position
时间窗: In a single session, 10 data points per phase were collected
Measured using PostureScreen Mobile Application and all measured bilaterally Neck position measured from (EAM to Acrominom) * angulation in degrees (flexion values positive/extension values negative) * translation in inches (anterior values positive and posterior values negative)
Postural Alignment - Trunk Position
时间窗: In a single session, 10 data points per phase were collected
Measured using PostureScreen Mobile Application and all measured bilaterally Trunk position measure form Acrominom to Greater Trochanter of femur, * angulation in degrees (flexion values positive/extension values negative) * translation in inches (anterior values positive and posterior values negative)
Postural Alignment - Hip/Knee Position
时间窗: In a single session, 10 data points per phase were collected
Measured using PostureScreen Mobile Application and all measured bilaterally Hip/knee position measured from greater trochanter of femur to lateral epicondyle of femur * angulation in degrees (flexion values positive/extension values negative) * translation in inches (anterior values positive and posterior values negative)
次要结局
- Postural Sway - Center of pressure position(Single session)
- Postural Sway - Center of pressure velocity(Single session)
- Researcher Developed Survey on the Experience of the Brace - No Formal Name or Abbreviation(Single Session)