Community Testing of Wearable Assistance
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Walking speed
研究概览
简要总结
This feasibility study looks to evaluate ankle exoskeleton assistance in community settings for individuals with cerebral palsy.
详细描述
Participants will undergo consent (if not done over the phone), history/physical/activity questionnaire, and orthotic device fitting. Following device fitting, the participants will practice walking with powered assistance.
Next, participants will complete "pre" walking tests with and without the device (order randomized) on a 15-minute pre planned community walk in close proximity with their own home. Distance, time, heart-rate, and perceived exertion will be recorded. The expected duration is 1-2 hours.
Next, participants will be asked to complete (under parental supervision for minors) the pre-determined walking route every day for 1 week with or without ankle exoskeleton assistance (block randomized). Following the first week of independent walking practice, participants will complete "post" walking tests with and without the device on the same walking route. Distance, time, heart-rate, and perceived exertion will be recorded. The expected duration is 1-2 hours.
Participants will then have a 2-6 week washout period.
Following this washout, the pre- and post-assessments will be completed before and after, respectively, another week of identical community walking practice completed under the remaining condition (either exoskeleton or no exoskeleton).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral palsy
- •Gross Motor Function Classification Level I, II, or III
- •Able to walk for at least 20 minutes with or without a walking aid
- •Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking
- •Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
排除标准
- •Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time.
- •Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.
结局指标
主要结局
Walking speed
时间窗: through study completion, an average of one week
Change in walking speed (measured in meters per second)
次要结局
- Step length(Through study completion, an average of one week)
- Heart-rate(Through study completion, an average of one week)
- Perceived exertion(Through study completion, an average of one week)