跳至主要内容
临床试验/NCT06438835
NCT06438835进行中(未招募)不适用

Development & Evaluation of Pneumatic Artificial Muscle(PAM) for Patients With Ankle Foot Orthosis(AFO)

Superior University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
4
试验地点
1
主要终点
Functional Mobility

研究概览

简要总结

Pneumatic Artificial Muscles (PAMs), inspired by the structure and function of natural muscles, offer a lightweight and adaptable solution compared to traditional rigid Ankle Foot Orthosis(AFOs).

详细描述

The development process involves design optimization to ensure proper, fit, functionality and durability. Researchers utilize advanced materials and manufacturing techniques to create PAMs that mimic the natural movement of the ankle joint while providing sufficient support and flexibility. Evaluation of PAMs involves rigorous testing in both laboratory settings and real world environments. Bio-mechanical analysis assesses the performance of PAMs during various activities such as walking, running and stair negotiation. Critical trails involving patients with AFOs provide valueable feedback on usability, comfort and overall satisfaction. Additionally, long-term studied monitor the durability and reliability of PAMs over extended periods of use. Overall, the development and evaluation of PAMs for patient with AFOs represent a significant advancement in assistive technology. By offering a more natural and adaptive solution for gait assistance, PAMs enhance mobility, independence and quality of life for individuals with mobility impairments.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of droop foot
  • Ability to tolerate pneumatic pressure
  • Sufficient muscle strength activation

排除标准

  • Allergy to materials used in device fabrication
  • Severe muscle weakness preventing activation
  • Uncontrolled hypertension, pregnancy.

结局指标

主要结局

Functional Mobility

时间窗: 12 months

Functional mobility is a person's physiological ability to move independently and safely in a variety of environments in order to accomplish functional activities or tasks and to participate in the activities of daily living, at home, work and in the community

Range of motion (ROM)

时间窗: 12 months

Range of motion means the extent or limit to which a part of the body can be moved around a joint or a fixed point; the totality of movement a joint is capable of doing. Range of motion of a joint is gauged during passive ROM (assisted) PROM or active ROM (independent) AROM.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Naveed Babur

Principal Investigator

Superior University

研究点 (1)

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