Criteria for Advanced Prosthetic Foot Prescription
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Change in 6-min walk distance for each prosthetic foot type
研究概览
简要总结
The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2) Correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR, articulating ESR, and active plantar flexion ESR ankle-foot units.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor and statistician will be blinded to foot type during data processing and analysis
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DEERS eligible Veteran or Service Member, or civilian with unilateral transtibial amputation
- •Currently using an Energy Storing and Returning prosthetic foot with a well-fitting socket as a primary or back-up prosthesis
- •Achieved a "Modified Independence" score on the Functional Independence Measure (FIM) for the locomotion mobility items
- •Has a minimum clearance of 8 ¾ inches to accommodate all feet
排除标准
- •Has active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair their ability to participate in all functional outcome measures
- •Has any comorbidity that results in rapid limb volume changes (i.e. end stage renal disease with dialysis),
- •Weighs more than 275 pounds, the maximum product weight load
- •Is unable or unwilling to comply with all research visits
- •Has cognitive deficit(s) or mental health pathology limiting a subject's ability to participate fully in the study
- •Women who are pregnant or plan to become pregnant during study activities. This will be determined by asking the participant if they are pregnant or if they believe that they may be pregnant. This question will only be asked at inclusion, as biomechanical changes will only be impacted if the woman is in the 2nd or 3rd trimester, and will not be impacted if the participant becomes pregnant while in the study.
- •Poorly fitting socket
- •Vision loss that requires use of an assistive device for gait
- •Upper Limb Amputation
研究组 & 干预措施
Articulating ESR Prosthetic Foot First
Subjects will start with an Articulating ESR prosthetic foot first for 1 week, then will complete an additional week with the ESR prosthetic foot, and a powered prosthetic foot for 1 week.The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities.
干预措施: Articulating ESR Prosthetic Foot First (Device)
Powered Prosthetic Foot First
Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot and an ESR prosthetic foot for 1 week. The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities.
干预措施: Powered Prosthetic Foot First (Device)
ESR Prosthetic Foot First
Subject will start with an energy storing and returning (ESR) prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot, and a powered prosthetic foot for 1 week. During the final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
干预措施: ESR Prosthetic Foot First (Device)
结局指标
主要结局
Change in 6-min walk distance for each prosthetic foot type
时间窗: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.
Change in TUG times for each prosthetic foot type
时间窗: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The TUG measures the time taken by an individual to stand up from a standard arm chair, walk a distance of 10 feet, turn, walk back to the chair, and sit down.
Change in 4SST times for each prosthetic foot type
时间窗: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The four-square step test is a higher order complex task assessing dynamic balance.
Change in AmpPRO for each prosthetic foot type
时间窗: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.
Change in Stair Assessment Index (SAI) for each prosthetic foot type
时间窗: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The SAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a staircase.
Change in Hill Assessment Index (HAI) for each prosthetic foot type
时间窗: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The HAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a ramp.
Change in Gait Evaluation for each prosthetic foot type
时间窗: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Biomechanical evaluation of gait.
次要结局
- Change in Short Form (SF)-12 for each prosthetic foot type(Once per week, at Week 1, Week 2, and Week 3 after enrollment)
- Change in responses to Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) for each prosthetic foot type(Once per week, at Week 1, Week 2, and Week 3 after enrollment)
- Change in Prosthetic Evaluation Questionnaire (PEQ) score for each prosthetic foot type(Once per week, at Week 1, Week 2, and Week 3 after enrollment)
- Change in OPUS for each prosthetic foot type(Once per week, at Week 1, Week 2, and Week 3 after enrollment)
- Final Visit Guided Interview(Administered one time at Final Visit, which will occur 7 weeks after enrollment.)
研究者
Jason Maikos
Director, VISN 2 Gait and Motion Analysis Laboratory
VA New York Harbor Healthcare System