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

Orthopedic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06438835
• Other study ID #: MSRSW/Batch-Fall22/703
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Superior University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: September 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Diagnostic Test:
• PneuFlex AFO Assist
It features a pneumatic artificial muscle designed to enhance ankle foot orthosis functionally for patients with mobility issues.

Locations

Country	Name	City	State
Pakistan	Al-Ghani rehabilitation centre. Opposite to Misaq-ul-mall	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Superior University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Mobility	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	12 months
Primary	Range of motion (ROM)	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.	12 months