Personalizing MPK Prescription for Individuals With Transfemoral Amputation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Ten Meter Walking Test
研究概览
简要总结
In current clinical prosthetic practice, there is no evidence based method for selecting a microprocessor knee (MPK) joint for a patient with an above the knee amputation. Of individuals with amputation in veteran and service member populations, approximately 35% present with an above the knee amputation. It is well understood in clinical practice that MPKs provide numerous benefits to patients with amputations above the knee including improved gait, safety, comfort, confidence, reduced falls, balance, patient satisfaction and reduced energy expenditure, greater ease in negotiating varying terrains, improvements in multi-tasking and cost effectiveness. Studies that have investigated commercially available MPKs tend to lump all of them together within a single group rather than teasing out individual differences between each knee. Therefore, clinicians are left to rely on their own intuition and past experiences with an MPK when selecting for a patient with an above the knee amputation rather than making their decision based on evidence collected from the specific patient. This may mean that some individuals with an above the knee amputation may not be receiving the best component for them which may delay or inhibit their rehabilitation potential following their amputation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A unilateral transfemoral amputation of the lower limb at least six months post fitting of definitive lower extremity prosthesis
- •Habitual use of a lower extremity prosthesis in daily living activities (based on assessment of a physiatrist and/or prosthetist and patient self-report)
- •Aged between 18 to 75 years
- •K3 or K4 level ambulators who can perform all locomotor tasks of interest (based on assessment of a physiatrist and/or prosthetist)
排除标准
- •Individuals with any significant neuromuscular or musculoskeletal disorder or other comorbidity that would interfere with participation (based on assessment of the physiatrist and/or prosthetist and patient self-report)
- •Individuals who have open wounds on their residual limb
- •Individuals with known visual impairments that would prevent them from safely operating a prosthesis during over ground walking or ascending stairs (based on assessment of the physiatrist and/or prosthetist and patient self-report)
- •Individuals with known hearing impairments or who use hearing aids that would prevent them from responding to an auditory instruction (based on assessment of the physiatrist and/or prosthetist and patient self-report)
- •Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments
结局指标
主要结局
Ten Meter Walking Test
时间窗: 1 month
Self selected walking speed over ten meters of walking over ground.
Two Minute Walking Test
时间窗: 1 month
Self selected walking speed over two minutes of walking over ground.
Prosthetic Evaluation Questionnaire (PEQ)
时间窗: 1 month
A patient reported survey on perceptions of a prosthesis. Scores range zero to one hundred with zero being representing a negative patient reported outcome and one hundred representing a positive patient reported outcome.
次要结局
- Narrowing Beam Walking Test(1 month)
- Reported Falls(1 month)
- Stance Time Asymmetry Index(1 month)
- Physiological Cost Index(1 month)
- Stair Ascent Speed(1 month)
- Stair Descent Speed(1 month)
- Ramp Ascent Speed(1 month)
- Ramp Descent Speed(1 month)
- Steps Per Day(1 month)
研究者
Kinsey Herrin
Senior Research Scientist
Georgia Institute of Technology