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

Not Applicable
Active, not recruiting
Conditions
Orthopedic Disorder
Interventions
Diagnostic Test: PneuFlex AFO Assist
Registration Number
NCT06438835
Lead Sponsor
Superior University
Brief Summary

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).

Detailed Description

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
4
Inclusion Criteria
  • Diagnosis of droop foot
  • Ability to tolerate pneumatic pressure
  • Sufficient muscle strength activation
Exclusion Criteria
  • Allergy to materials used in device fabrication
  • Severe muscle weakness preventing activation
  • Uncontrolled hypertension, pregnancy.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
PneuFlex AFO AssistPneuFlex AFO Assist-
Primary Outcome Measures
NameTimeMethod
Functional Mobility12 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)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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Al-Ghani rehabilitation centre. Opposite to Misaq-ul-mall

🇵🇰

Faisalābad, Punjab, Pakistan

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