Powered KAFO for Mobility Impairments
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on mobility aids rather than medication use.
What data supports the effectiveness of the treatment Indego Nomad® Powered Knee-Ankle-Foot Orthosis for mobility impairments?
Research shows that knee-ankle-foot orthoses (KAFOs) can improve walking speed and step length in people with conditions like stroke and poliomyelitis. New designs, such as those with stance control, help users walk more naturally by allowing the knee to move during walking, which may suggest potential benefits for the Indego Nomad® Powered KAFO.12345
Is the Powered KAFO generally safe for human use?
How does the Indego Nomad® Powered KAFO treatment differ from other treatments for mobility impairments?
The Indego Nomad® Powered KAFO is unique because it is a powered orthosis that assists with both knee and ankle movement, potentially offering more dynamic support compared to traditional KAFOs, which often have locked joints and can lead to increased energy expenditure and other complications over time.23689
What is the purpose of this trial?
This trial is testing a special powered leg brace called the Nomad powered KAFO. It aims to help people who have trouble walking due to injuries. The brace provides extra support and power to make walking easier and safer.
Eligibility Criteria
This trial is for individuals with conditions like paralysis, muscular dystrophy, or spinal cord injury that affect walking. Participants must regularly use a leg brace due to their condition, be able to follow the study's instructions, and consent to wearing an activity monitor for three months.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Training and Fitting
Participants receive training and fitting for the Nomad powered KAFO or their own Traditional Assistive Device
Home Trial with Device
Participants use the assigned device (Nomad KAFO or Traditional Assistive Device) for a 3-month home trial, followed by outcomes testing
Crossover and Second Home Trial
Participants switch devices and undergo a second 3-month home trial with outcomes testing
Follow-up
Participants are monitored for safety and effectiveness after the completion of both home trials
Treatment Details
Interventions
- Indego Nomad® Powered Knee-Ankle-Foot Orthosis
Indego Nomad® Powered Knee-Ankle-Foot Orthosis is already approved in United States, European Union for the following indications:
- Musculoskeletal injuries affecting lower extremities
- Neurological injuries affecting lower extremities
- Lower-extremity impairments due to neurological or neuromuscular diseases
- Lower-extremity impairments due to orthopedic diseases or trauma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shirley Ryan AbilityLab
Lead Sponsor