NCT05411601尚未招募不适用
Numerical Standard of Anthropomorphicity of Prosthetic Feet for Improvement of Amputee Performance
PolyOrth International0 个研究点目标入组 56 人开始时间: 2022年9月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 主要终点
- IAb of the selected prosthetic feet
研究概览
简要总结
The study concerns the testing of methodology of attachment of external foot prothesis based on anthropomorphism criteria
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral lower transtibial amputation
- •Prosthetic user with socket type attachment (Cohort 1) or with direct skeletal attachment (Cohort 2) and be able to walk 50 meters independently,
- •Between 18-60 years of age,
- •Able to follow instructions,
- •Able to provide consent.
排除标准
- •problems on the residuum,
- •Non-prosthetic user,
- •Bilateral amputation,
- •Self-reported pain levels greater than 4 out of 10 at study outset,
- •Experienced a fall within the last 8 weeks before assessment,
- •Mental illness or intellectual impairment compromising participant's ability to give informed consent,
- •Injuries involving contralateral (intact) limb,
- •Major uncorrected visual deficit,
- •History of epilepsy or recurrent dizziness,
结局指标
主要结局
IAb of the selected prosthetic feet
时间窗: 30 days
To establish IAb of the selected prosthetic feet via biomechanical gait testing
Stiffness and the index of anthropomorphicity IAm
时间窗: 30 days
Range of ankle stiffnesses, including three prostheses currently recommended to patients with direct skeletal attachment
次要结局
未报告次要终点
研究者
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