The Effect of Alternative Prosthetic Alignments on Sit-to-Stand Proficiency in Transtibial Amputees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- 5 Time Sit to Stand Test
研究概览
简要总结
The purpose of this graduate student research study is to determine the effect of various linear and angular prosthetic alignments on K1-K3 unilateral or bilateral TT amputees, as well as test for proficiency, comfort, balance, heart rate and fit during sit to stands.
详细描述
Initial Visit:
- Informed consent
- HIPAA
- Foot Inspection
- Review expectations
- Take measurements
- Casting
Second Visit: Fitting and adjusting accordingly.
- One person will conduct all the measurements, casting, check sockets, etc. to evade inconsistencies in data collection.
- Begin conducting practice runs on Balance Master at LLU-East Campus.
Third, Fourth and Fifth Visit: Testing (5-10-minute rest period in between each test) *Testing will be video recorded for re-assessment of subjects*
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
A sock will be placed over the prosthesis in order for the participant to not know which alignment is used.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female below knee amputees (bi-lateral or unilateral)
- •18-70 years of age
- •K1-K3 (K-levels/activity levels)
- •K1=patient has the ability or potential to use a prosthesis for transfers or walking on level surfaces at a fixed speed (typical limited or unlimited household ambulator).
- •K2=patient has the ability or potential for walking with the ability to traverse most low-level environmental barriers such as curbs, stairs, or uneven surfaces (typical community ambulator).
- •K3=patient has the ability or potential for walking with variable speed. Has the ability to traverse most environmental barriers and may have vocational, exercise, or recreational activities that demand prosthetic use beyond simple locomotion.
- •Those who wear a prosthesis daily for the purpose of walking
- •Able to get in and out of a chair
- •Prosthetic foot that has the same functional components as the subject's current one
排除标准
- •Amputation at birth
- •Foot amputation at ankle
- •Uncontrolled edema in leg compartments
- •Compromised skin of the residual limb
- •Patients that are 3 months or less post-amputation
研究组 & 干预措施
Neutral Alignment Group
A straight pylon with the ankle at neutral.
干预措施: Neutral Alignment (Other)
Anterior Alignment Group
An anteriorly displaced pylon with ankle dorsiflexion at 5 degrees.
干预措施: Anterior Alignment (Other)
Posterior Alignment Group
A posteriorly displaced pylon with 5 degrees of plantarflexion at the ankle.
干预措施: Posterior Alignment (Other)
结局指标
主要结局
5 Time Sit to Stand Test
时间窗: three weeks
The sit to stand test will be administered five times uninterrupted. The participants will sit in a chair and stand up preferably unassisted by researchers. They will be timed.
次要结局
- Balance test(three weeks)
- Activities-Specific Balance Confidence Questionnaire(three weeks)
研究者
Michael Davidson
Assistant Professor Orthotics and Prosthetics
Loma Linda University