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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06438835
Enrollment
4
Registered
2024-06-03
Start date
2023-10-01
Completion date
2024-09-01
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Disorder

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.

Interventions

DIAGNOSTIC_TESTPneuFlex AFO Assist

It features a pneumatic artificial muscle designed to enhance ankle foot orthosis functionally for patients with mobility issues.

Sponsors

Superior University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional Mobility12 monthsFunctional 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 monthsRange 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026