Individualizing Powered Orthotic Intervention for Improved Gait Outcomes Using ML-enabled Methods
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- 10MWT (Aim 1)
研究概览
简要总结
The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.
详细描述
The long-term goal of this project is to improve the outcomes of robot-assisted exercise interventions for patients with reconstructed lower limb following high-energy lower extremity traumas using novel machine learning methods to enable individualized ankle foot orthosis (AFO) designs and self-adaptive AFO assistance.
The main hypothesis predicts greater comfort and lower pain levels when using the new AFO as well as improvements in gait mechanics, which will outperform those induced by patients' daily-use AFOs. The main goal is this adaptive assistance will encourage the wearer's active engagement in RAGT thereby promoting patient self-efficacy/satisfaction and leading to improvements in ambulation after a 6-week rehabilitation program.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a lower limb injury greater than a year ago.
- •Be 18-80 years old.
- •Be able to stand for 30 minutes.
- •Have enough range of motion in my ankle to comfortably wear the AFO.
- •Be able to follow directions and commands.
- •Be willing and able to give informed consent.
- •Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.
排除标准
- •Have any joint or muscle tightness that would limit my movement while walking with the AFO.
- •Have any medical issue that prevents me from supporting my weight and walking (e.g. orthopedic injuries, pain, severe spasticity).
- •Have any medical issues that affect my unaffected side.
- •Have skin issues that would prevent wearing the device.
- •Have a pre-existing condition that caused exercise intolerance. (Documented uncontrolled hypertension, coronary artery disease, abnormal heart rate or rhythm, or congestive heart failure).
- •Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
- •Have nervous system issues that affect my movement (for example Parkinson's disease, multiple sclerosis).
- •Have additional orthopedic issues that interfere with my walking or limit my range of motion in my legs.
- •Have any other medical conditions that my doctor or physical therapist feels would affect my ability to use the device.
研究组 & 干预措施
Adults with lower limb injury
All enrolled subjects will be asked to complete the intervention.
干预措施: Utilization of motorized orthosis (Device)
结局指标
主要结局
10MWT (Aim 1)
时间窗: Measured before and after 6 week intervention to assess change from baseline.
10 meter walk test to evaluate walking speed after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
6MWT (Aim 1)
时间窗: Measured before and after 6 week intervention to assess change from baseline.
6 minute walking test to evaluate endurance after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
TUG (Aim 1)
时间窗: Measured before and after 6 week intervention to assess change from baseline.
Timed up and go (TUG) test to measure functional balance and walking ability after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
次要结局
未报告次要终点
研究者
Karen J. Nolan, PhD
Associate DIrector
Kessler Foundation