Establishing the Preliminary Utility of a Novel Pediatric Manual Mobile Standing Wheelchair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of a modified Wheelchair Skills Test with Participants wheelchair to the PedMMSWC
研究概览
简要总结
To establish the preliminary utility of a novel pediatric manual mobile standing wheelchair (PedMMSWC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8 - 17 years old
- •Primarily use a manual wheelchair for daily mobility
- •Are actively enrolled in a standing program
- •Fit the height and weight requirements of the PedMMSWC
- •Can follow simple verbal instructions
- •Are able to speak and read in English
排除标准
- •Have insufficient trunk control to maneuver in seated and standing positions
- •Have lower limb contracture which would preclude standing
- •Have had orthopedic surgery within the last twelve months
- •Have pressure injuries at the location where the PedMMSWC interfaces
- •Have insufficient fine motor skills to independently initiate the sit-to-stand function
- •Have a history of uncontrolled seizures or cardiovascular conditions that would make participation unsafe
研究组 & 干预措施
Experiment 1: In-Lab Testing
Perform tasks in a laboratory environment designed to test the maneuverability and ease of use of the PedMMSWC as compared to commercial devices.
干预措施: PedMMSWC Wheelchair User Testing (Device)
Experiment 2: Simulated Community and Home Testing
Perform tasks in a simulated home, school, and community setting using the PedMedWC wheelchair.
干预措施: PedMMSWC Simulated Home, School, Community Environment (Device)
结局指标
主要结局
Comparison of a modified Wheelchair Skills Test with Participants wheelchair to the PedMMSWC
时间窗: Day 1
The primary outcome measure for this aim is user performance on a modified Wheelchair Skills Test (mWST) under three test conditions: PedMMSWC in the seated position, PedMMSWC in the standing position, and the individuals' daily wheelchair. The investigators hypothesize that performance on the mWST in the PedMMSWC will not be clinically inferior to performance in individuals' daily wheelchairs.
次要结局
- 100-Meter Roll Test (meters per second)(Day 1)
- 100-Meter Roll Test (perceived exertion)(Day 1)
- Pressure Mapping (peak pressure (mm/hg))(Day 1)
- Pressure Mapping (coefficient of variation)(Day 1)
- Functional Mobility Assessment - Family Centered (FMA-FC)(Day 1 or 2)
- Participant and Caregiver Perceptions of Device(Day 1 or Day 2)