What side effects are associated with this type of intervention?

Common treatments for paralysis that provide powered assistance, such as powered orthotic devices and functional electrical stimulation (FES), can have several side effects. These may include skin irritation or pressure sores from prolonged use of the device, muscle fatigue or discomfort due to electrical stimulation, and potential mechanical issues with the device that could affect its performance. Additionally, there may be a learning curve for patients to effectively use these devices, which could temporarily impact mobility and stability. Regular monitoring and adjustments by healthcare professionals are essential to minimize these side effects and ensure optimal function and comfort.

What prior FDA approvals exist?

The FDA has approved various treatments for paralysis that aim to improve mobility and stability. These include functional electrical stimulation (FES) devices, which use electrical currents to activate nerves and muscles, thereby aiding movement. Additionally, powered exoskeletons, such as the ReWalk and EksoGT, have been approved to assist individuals with spinal cord injuries in walking. These devices provide powered assistance to the lower extremities, similar to the Nomad powered KAFO, enhancing mobility and stability for users.

What other types of research exist?

Promising alternatives to the Nomad powered KAFO for paralysis patients include: 1) Exoskeletons like the ReWalk and EksoGT, which provide powered assistance for walking and standing. 2) Advanced prosthetics with energy regeneration and adaptive control, such as the Ottobock C-Brace. 3) Wearable neuromodulation devices that enhance muscle function and coordination. These alternatives are designed to improve mobility, stability, and overall quality of life for patients with lower-extremity impairments.

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Powered Orthosis

Powered KAFO for Mobility Impairments

N/A

Recruiting

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cognitive ability to understand and follow the study protocol; willingness to provide informed consent

Regular and compliant use of a unilateral or bilateral KAFO or SCO or other passive KAFOs for impairment due to neurological or neuromuscular disease, orthopedic disease, or trauma

Must not have

Inability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)

Flexion contracture in the knee and/or hip joint in excess of 15 degrees

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during each 3 month home trial with each device.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The Nomad P-KAFO is being tested for its effectiveness in improving mobility and quality of life over three months compared to participants' usual braces. It involves recording daily activities with a sensor and assessing mobility using both the participant's own brace and the Nomad P-KAFO.

What are the potential side effects?

While specific side effects are not listed, potential issues may include discomfort from wearing new orthotic devices, skin irritation at contact points of the device, or muscle fatigue from altered gait patterns during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study details and agree to participate.

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I regularly use a leg brace due to a neurological, muscle, or bone condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot keep my body stable, even with support like crutches.

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My knee or hip cannot fully straighten, bending more than 15 degrees.

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My knee is bent inward/outward more than 15 degrees and can't be fixed.

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I experience severe muscle stiffness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during each 3 month home trial with each device.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during each 3 month home trial with each device.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during each 3 month home trial with each device. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 10 Meter Walk Test speed

Secondary study objectives

Activities Specific Balance Confidence Scale

Berg Balance Test

Borg Rate of Perceived Exertion

+13 more

Other study objectives

Community Mobility

Cross Walk Blinking Signal Test

Self Reported Goals

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group AExperimental Treatment1 Intervention

Group A receives the intervention Nomad KAFO first; fitting \& training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. Group A then will cross over and train with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing.

Group II: Group BActive Control1 Intervention

Group B receives training in their own Traditional Assistive Device first; training will occur with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. Group B then will cross over and receive the intervention Nomad KAFO; fitting \& training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for paralysis that improve mobility and stability include powered orthotic devices like the Nomad powered KAFO, physical therapy, and electrical stimulation. Powered orthotic devices provide mechanical assistance to the knee, ankle, and foot, enhancing the patient's ability to walk by compensating for muscle weakness and improving joint stability. Physical therapy focuses on strengthening muscles, improving coordination, and increasing range of motion through targeted exercises. Electrical stimulation uses electrical impulses to activate muscles, promoting muscle strength and function. These treatments are crucial for paralysis patients as they enhance mobility, reduce the risk of falls, and improve overall quality of life by enabling greater independence.

Use of electrical stimulation and exercise to increase muscle strength in a patient after surgery for cervical spondylotic myelopathy.