What side effects are associated with this type of intervention?

Common treatments for movement disorders involving mechanical assistance and rehabilitation, such as wearable exoskeletons and electrical stimulation, generally aim to improve muscle activity, joint motion, and gait performance. Known side effects of these treatments can include muscle fatigue, skin irritation from prolonged use of devices, and discomfort or pain due to improper fit or excessive use. Electrical stimulation may also cause mild muscle soreness or twitching. It is important for patients to be monitored closely to adjust the treatment as needed to minimize these side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for movement disorders, including pharmacological agents like levodopa for Parkinson's disease and VMAT2 inhibitors such as tetrabenazine for Huntington's disease. Device-based therapies include deep brain stimulation (DBS) for Parkinson's disease, which helps manage motor symptoms. While specific FDA approvals for wearable lower-limb exoskeletons are not detailed, these devices are being studied for their potential to improve gait and mobility in patients with movement disorders, offering a promising avenue for mechanical assistance and rehabilitation.

What other types of research exist?

Promising novel alternatives to wearable lower-limb exoskeletons for movement disorder patients include: 1) Deep Brain Stimulation (DBS), which has shown long-term efficacy in improving motor symptoms in conditions like Parkinson's disease and essential tremor. 2) Intrathecal Baclofen Therapy, which can effectively reduce spasticity in cerebral palsy patients. 3) Advanced Physical Therapy Techniques, such as high-intensity resistance training and balance training, which have demonstrated benefits in improving motor function and reducing symptoms. 4) Augmentative Communication Devices and Adaptive Equipment, which can assist in daily activities and improve overall quality of life.

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Leg Stretching Exoskeleton for Spasticity

N/A

Waitlist Available

Led By Steven W Brose

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Participants should not experience another neurological disorder except their primary diagnosed neurological condition (spinal cord injury)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special leg suit designed to help people with movement problems due to neurological conditions. The suit uses sensors to assist with leg movements and stretching, aiming to improve walking and daily activities.

Who is the study for?

This trial is for veterans with spasticity from a spinal cord injury that's at least 6 months old. They must be stable, able to consent, follow instructions, and not pregnant or recovering from recent surgeries. Participants should weigh under 300 lbs and not have other neurological disorders or conditions affecting mobility.

What is being tested?

The study tests a wearable robotic exoskeleton designed to improve leg function and walking in people with movement issues due to neurological disorders. It involves exercises like leg stretching and treadmill walking to see how it affects muscle activity, joint motion, and gait.

What are the potential side effects?

While the description doesn't specify side effects, potential ones may include discomfort while wearing the device, skin irritation where it attaches, muscle fatigue from use, or strain on joints during movement activities.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have a spinal cord injury and no other neurological disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 24 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

3D postures

Joint angles

Joint angular velocities

Secondary study objectives

Follow-up sessions

Wearability and fit

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Robotic ExoskeletonExperimental Treatment1 Intervention

All participants will be interfered with a wearable robotic exoskeleton.

0 / 1Eligibility 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 movement disorders include pharmacologic interventions, physical therapy, and mechanical assistance devices like wearable exoskeletons. Wearable exoskeletons work by providing external support and enhancing the user's own movements, thereby improving gait and leg function. This mechanical assistance helps to restore range of motion and gait ability, which is crucial for patients with movement disorders as it can significantly enhance their mobility and quality of life. Understanding these mechanisms allows patients and clinicians to make informed decisions about incorporating such technologies into treatment plans, optimizing outcomes, and tailoring interventions to individual needs.

Associations Between Muscle Synergies and Treatment Outcomes in Cerebral Palsy Are Robust Across Clinical Centers.Motor Activity in Aging: An Integrated Approach for Better Quality of Life.