An Uneven Terrain Surface to Improve Locomotor Robustness in People With Amputation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in single limb stand time from baseline
研究概览
简要总结
To attain high levels of mobility, people with lower limb amputation must build both the skill and the confidence to rely on their prosthesis in the environments that they will encounter in daily life. The purpose of this research is to determine whether practicing walking on an uneven terrain surface, specifically designed to present a modest, manageable disturbance to walking, can improve balance, locomotor flexibility (i.e. the ability to adapt walking to different walking contexts) and balance confidence, to a greater extent than walking on level ground alone. This preliminary study aims to determine whether uneven terrain walking is feasible and acceptable in the target population, and also to establish preliminary efficacy.
详细描述
The long-term focus of this research is to investigate an uneven terrain training paradigm as an intervention to improve locomotor skill and confidence in lower limb prosthesis users; specifically to determine whether by inducing step-to-step variability in a safe environment, through training on an uneven terrain surface, individuals may develop more adaptable gait, and greater confidence in their mobility. We hypothesize that inducing a manageable level of variability into walking patterns during training will lead to greater balance, locomotor flexibility, and balance confidence. The surface has shallow contours that alter foot-ground interactions at each step, disrupting habitual movement patterns.
The aim of this study is to establish feasibility, acceptability and preliminary efficacy of the uneven surface as a mobility training tool for lower limb prosthesis users. Ambulatory lower limb prosthesis users will attend a biomechanics laboratory on two occasions, during which they will complete walking practice sessions on a flat surface and on an uneven surface. A crossover design will be employed, with walking surface order randomized across participants. Preliminary efficacy will be established based on functional tasks and self-efficacy questions administered before and after the sessions on each day. Feasibility and acceptability will be established based on feasibility study objectives from Orsmond & Cohn's feasibility framework.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will be blinded to arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lower limb amputation at ankle level or above
- •properly fitted with a walking prosthesis, used regularly for home and/or community ambulation
- •good socket fit assessed by a score of 7-10 on the socket fit comfort score (Hanspal et at., 2003).
- •able to walk for two minutes at a time with or without an assistive device
- •willing to travel to the test site two times for training and testing.
排除标准
- •leg/foot ulcer/sore or other conditions that cause pain during weight-bearing
- •cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity
- •unilateral or bilateral upper limb absence or loss at the wrist and above
- •diagnosis of cognitive disturbances
- •allergy to medical adhesives
- •women who are pregnant or think they may be pregnant
- •acute illness
- •dizziness on the day of testing
结局指标
主要结局
Change in single limb stand time from baseline
时间窗: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
The duration the participant is able to stand on one limb without touching the floor with the raised foot, out of a maximum of 30 seconds.
Change in balance self-efficacy from baseline
时间窗: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
Participants will rate on a scale of 0 (not confident at all) to 10 (extremely confident) their confidence in their ability to walk specified distances on the narrow beam.
次要结局
- Change from baseline in average walking speed(Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.)
- Change from baseline in narrow beam walking distance(Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.)
- Change from baseline in horizontal ladder completion time(Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.)
- Change from baseline in average step width during level walking(Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.)
- Change from baseline in average step length during level walking(Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.)
- Change from baseline in step width variability during level walking(Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.)
研究者
Jenny Kent
Assistant Professor
University of Nevada, Las Vegas