What side effects are associated with this type of intervention?

Common treatments for spinal cord injury that involve mechanical assistance and resistance, such as robotic exoskeletons, generally aim to improve gait and mobility. Known side effects of these treatments can include temporary muscle soreness, fatigue, and skin irritation from the device. In some cases, improper use or fit of the exoskeleton can lead to joint pain or muscle strain. It is important for patients to be closely monitored by healthcare professionals to minimize these risks and ensure the device is used correctly.

What prior FDA approvals exist?

The FDA has approved various treatments for spinal cord injury, including mechanical devices that assist with mobility. One notable example is the robotic exoskeleton, which provides mechanical assistance and resistance to improve gait and walking ability in individuals with movement disorders. These devices are designed to support and enhance the user's own movements, offering a new form of gait training that can be customized to the individual's needs. While specific FDA approvals for robotic exoskeletons may vary, these devices represent a significant advancement in the rehabilitation and treatment of spinal cord injuries.

What other types of research exist?

Promising novel alternatives to robotic exoskeletons for spinal cord injury patients include: 1) Gastric electrical stimulation, which has shown potential in enhancing neuroplasticity and motor function. 2) Deep brain stimulation, particularly targeting the globus pallidus internus, which has been effective in managing dystonia and improving motor control. 3) Selective dorsal rhizotomy, which can reduce spasticity and improve mobility. 4) Advanced pharmacological treatments, such as antisense oligonucleotide therapy, which are being explored for neurodegenerative conditions and may have applications in spinal cord injury.

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Robotic Exoskeleton

Robotic Walking Device for Child Movement Disorders

N/A

Recruiting

Led By Thomas C Bulea, M.D.

Research Sponsored by National Institutes of Health Clinical Center (CC)

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a robotic exoskeleton that helps children with walking difficulties due to conditions like cerebral palsy or spinal cord injury. The device can either assist or challenge their walking to strengthen muscles and improve movement. Children will use the exoskeleton in different settings to see if it improves their ability to walk. Robotic exoskeletons have been increasingly used in pediatric rehabilitation to assist children with cerebral palsy in improving their walking abilities.

Who is the study for?

Children aged 3-17 with knee-related gait disorders from cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury. They must be able to walk at least 10 feet and commit to the study's duration. Pregnant individuals or those with other conditions affecting walking ability are excluded.

What is being tested?

The trial tests a pediatric robotic exoskeleton (P.REX/Agilik) designed for children with movement disorders. It involves three phases: standard therapy continuation, lab-based exoskeleton training with customized fitting, and home use of the device for walking practice.

What are the potential side effects?

Potential side effects may include discomfort from wearing the device, skin irritation where it attaches to the body, muscle fatigue due to exercise mode resistance or possible joint strain during usage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To evaluate the effectiveness of a longitudinal exoskeleton training program in the community, as opposed to a standard regimen of therapy of the same magnitude, at improving knee extension deficiency in children with CP, SB, iSCI or MD.

Secondary study objectives

To evaluate improvement in overground walking of children with CP, SB, iSCI or MD as a function of average gait speed while walking with the robotic exoskeleton

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

12 weeks-study intervention

Group II: Group BActive Control1 Intervention

12 weeks the control first.

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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 spinal cord injury (SCI) include physical therapy, pharmacologic interventions, and advanced technologies like robotic exoskeletons. Physical therapy aims to improve mobility and strength through targeted exercises. Pharmacologic treatments often focus on reducing inflammation and promoting nerve regeneration. Robotic exoskeletons, such as the one studied in the trial, provide mechanical assistance and resistance to aid walking. These devices help by supporting weakened muscles and providing resistance to strengthen them, thereby improving gait and overall mobility. This matters for SCI patients as it can significantly enhance their independence, reduce the risk of secondary complications, and improve their quality of life.