Development of Energy-storable Ankle-foot Orthosis Using 3D Printing Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 36-Item Short Form Survey (SF-36)
研究概览
简要总结
All participants were at least 6-month post-stroke and had unilateral limb involvement (8 right/4 left). The main inclusion criteria in selection of the participants in this study were as follows :(1) First stroke (2) At least 6 months post stroke (3) Able to stand for at least one minute without any assistive devices (4) Able to walk for at least 10 meters. All participants were instructed to walk with bare foot or with ankle-foot orthoses(AFOs) separately under gait detection of the motion capture system. Participants were further instructed to complete the 10 Meter Walk Test at a comfortable speed with BF or with AFOs separately. All participants were provided with sufficient rest between each trial. Patient demographics such as lower limb Brunnstrom stage and Modified Ashworth Scale (MAS) score were examined and recorded by experienced therapist. The satisfaction and outcome were measured by the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and SF-36. The kinematic and kinetic data were collected by Motion Analysis system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First stroke
- •At least 6 months post-stroke
- •Able to stand for at least one minute without any assistive devices
- •Able to walk for at least 10 meters.
排除标准
- •Unable to walk for at least 10 meters.
研究组 & 干预措施
Gait analysis with barefoot
Participants walk without assistance under gait detection.
Gait analysis with AFOs
Participants walk with AFOs under gait detection.
干预措施: 3D printing AFO, anterior AFO, off-the-shelf AFO (Device)
Satisfaction questionnaire
User feedback from the participants was obtained by questionnaire, the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and SF-36, to compare the satisfaction of AFOs
干预措施: 3D printing AFO, anterior AFO, off-the-shelf AFO (Device)
结局指标
主要结局
36-Item Short Form Survey (SF-36)
时间窗: one month after intervention
The eight-section questionnaire including vitality,physical functioning,bodily pain,general health perceptions, physical role functioning,emotional role functioning,social role functioning,mental health were surveyed to evaluate participant's quality of life
Kinematic analysis
时间窗: Baseline
A total of 22 reflective markers were attached to the anatomical landmarks of participants, and a motion capture system with eight cameras was used to collect the kinematics data.
10 Meter Walk Test (10MWT)
时间窗: Baseline
Each participant preformed three 10MWT trials under each condition, for a total of 9 trials, on the same day with sufficient time given to rest in between trials.
Numerical rating scale
时间窗: Baseline
Participant fatigue before and after the 10MWT for the 3 experimental conditions was measured via a 5-point numerical rating scale (NRS), with 1 indicating no fatigue and 5 indicating strong fatigue.
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
时间窗: Baseline
The 8 items of the questionnaire included Dimensions, Weight, Ease in Adjusting, Safety and Security, Durability , Ease of Use, Comfortable, and Effectiveness. Each item employed a 5-point scale, with 1-point representing not satisfied at all, and 5-point representing very satisfied.
次要结局
未报告次要终点