PlayGait: A Dynamic Exoskeleton to Improve Community Ambulation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Cadence
研究概览
简要总结
PlayGait is an investigational dynamic energy storage and return (ESR) lower-limb exoskeleton for young children with cerebral palsy (CP), that stores energy while the child is in the stance phase of walking and returns that energy in terminal stance and early swing phase of walking. PlayGait assists with the passive dynamics of walking through an exotendon (comprised of a spring in series with a cable). The overall objective of this investigational device is to promote correct walking patterns that encourage proper bone alignment, muscle recruitment, and strengthening during walking practice in young children with CP. The study will evaluate children with CP's activity levels in the community with and without PlayGait. The study will consist of three lab visits and two, 7-day periods at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3 - 4 years (at time of informed consent)
- •Hemiplegic cerebral palsy
- •If child uses an ankle-foot orthosis (AFO), parent/caregiver is willing to have the child stop wearing their prescribed AFO during data collections (lab sessions and two 7-day periods at home)
- •Ability to walk at least 10 meters without the use of assistive devices or AFOs
- •Ability to walk at least 1 minute without the use of assistive devices or AFOs
- •Stiff knee gait - less than normal knee flexion during swing phase
- •Hip flexion passive range of motion contracture less than 20 degrees
- •Gross Motor Function Classification System (GMFCS) Levels I-II
- •Modified Ashworth Scale (MAS) <=2 for the gastrocnemius soleus, rectus femoris, and hamstrings
- •Family has resources to attend all study sessions (transportation, schedule)
- •Ability to speak and understand in English
排除标准
- •Orthopedic surgery in the last year
- •Foster children or wards of the state
- •Use wheelchair or stroller mobility as their primary method of independent mobility
- •Severe visual impairment such that the visual impairment itself functionally limits mobility
- •Phenol or Botox injections to the legs in the last 3 months
- •Uncontrolled seizure disorder, defined as any seizure in the last 3 months that influenced mobility skills and function (seizures which did not affect mobility are acceptable)
- •Lower limb fracture in the last 3 months
- •Planned surgery or changes to movement disorder medication during the study period
- •Inability to understand directions sufficiently to complete the study assessments
- •Cognitive, behavioral, or any other issues that may not allow for effective study participation
- •Unwilling to complete the study protocol
结局指标
主要结局
Cadence
时间窗: 7 days with baseline condition; 7 days with PlayGait condition
Low, medium, and high activity rate
Shifts in cadence
时间窗: 7 days with baseline condition; 7 days with PlayGait condition
Shifts from low to medium cadence and shifts from medium to high cadence
次要结局
- 1 minute walk test(1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait)
- 10 meter walk test(1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait)
- Time of PlayGait use(PlayGait condition: 7 days in the community with PlayGait)
- Average steps per day(Baseline Condition: 7 days in the community without PlayGait (no lower-limb assistive devices); PlayGait condition: 7 days with PlayGait)
- Pediatric Balance Scale(1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait)