Functional Assessment of High-profile Crossover Feet in People With Syme's Amputation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Ratio Between Sound and Prosthetic Side Step Lengths
研究概览
简要总结
The purpose of this study is to compare the functional differences between two types of foot prostheses for people with ankle disarticulation (Syme's) amputations. The two feet being tested are low- and high-profile feet, with the difference being the latter has an extended keel and attaches to the posterior of the prosthetic socket, rather than the distal end. The hypothesis is that the high-profile foot (i.e., the crossover foot) will lead to functional and biomechanical improvements compared to low-profile feet.
详细描述
Syme's prostheses are typically limited to low-profile prosthetic feet due to clearance restrictions below the prosthetic socket. As a result, the functional benefits provided by the long residual limb are mitigated by prosthetic design limitations. Recently, high-profile, posteriorly-attaching crossover feet have been modified for use with people who have Syme's amputation. Crossover feet theoretically improve motion and energy storage-and-return compared to traditional foot options for the Syme's level. Crossover feet also have the potential to broaden the range of high-impact activities that can be performed with a single prosthesis. However, to date there is no empirical evidence that compares functional differences when walking with high-profile crossover feet compared to low-profile feet for people with Syme's amputation. This mixed-method pilot research will use a randomized, controlled within-participants design. Investigators will assess gait biomechanics, self-reported health outcomes, and qualitative interviews to compare relative advantages and disadvantages of traditional low-profile Syme's feet and high-profile crossover feet. This proposed work will create a foundation for future research that examines the potential benefits of crossover feet in people with Syme's amputation. In addition, results from this research will be used clinically to inform prosthetic options for people with limited clearance for distally-attached prosthetic feet.
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
- None
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
- •18 years of age or older
- •Have a unilateral Syme's amputation that occurred >1 year prior
- •Owns a crossover foot modified for Syme's use
- •Able to walk in the community without assistance
- •Able to read and write in English
排除标准
- •Have other amputations
- •Have a health condition that would limit completion of the study protocol (e.g., skin breakdown, heart disease)
结局指标
主要结局
Ratio Between Sound and Prosthetic Side Step Lengths
时间窗: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
The symmetry between prosthetic and sound side step lengths. Step lengths were calculated as the distance between heels from heel strike of the contralateral foot to heel strike of the ipsilateral foot.
Total Prosthetic Ankle Range of Motion
时间窗: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
The change in total angular motion of the ankle in the sagittal plane (e.g., dorsiflexion \& plantarflexion) during stance phase between prosthetic feet, in degrees
Prosthetic-side Energy Return
时间窗: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Intersegmental flow of power out of the prosthesis
Peak Sound-side Limb Loading
时间窗: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Maximum vertical ground reaction force in early stance
次要结局
- Preference Questionnaire(Session 4 (after 4 weeks of prosthesis wear, 2 weeks of prosthesis 1 and 2 weeks of prosthesis 2))
- Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item Short Form Version 1.2(Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear))
- Change in Activities-Specific Balance Confidence Scale (ABC)(Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear))
- Change in Trinity Amputation and Prosthesis Experience Scales- Revised Aesthetic Satisfaction(Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear))
研究者
Sara Morgan
Assistant Professor
University of Washington