NCT06438835

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 3, 2024

Last Update Submit

May 29, 2024

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

PneuFlex AFO Assist

EXPERIMENTAL
Diagnostic Test: PneuFlex AFO Assist

Interventions

PneuFlex AFO AssistDIAGNOSTIC_TEST

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

PneuFlex AFO Assist

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Faisalābad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2024

First Posted

June 3, 2024

Study Start

October 1, 2023

Primary Completion

April 1, 2024

Study Completion

September 1, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)