Leg Stretching Exoskeleton for Spasticity

Overseen By Steven W Brose

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Bone metabolism, muscle strength

Disqualifiers: Pregnancy, Hip/knee pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for the trial?

The trial requires that you do not take medications that affect bone metabolism, muscle strength, or cardiovascular performance. If you are on such medications, you may need to stop them to participate.

Is the leg stretching exoskeleton generally safe for humans?

The safety of leg stretching exoskeletons is still being studied, and while they have been approved for use, the risks are not fully understood yet. Reported adverse events and risks vary, and more research is needed to develop safety standards and regulations. ^{1 2 3 4 5}

How does the leg stretching exoskeleton treatment for spasticity differ from other treatments?

The leg stretching exoskeleton is unique because it uses a robotic device to provide controlled stretching of the legs, which can be adjusted based on the resistance felt during the stretch. This allows for a more precise and potentially more effective treatment compared to traditional manual stretching methods, and it can be used frequently at home or in clinics for long-term improvement. ^{4 5 6 7 8}

What data supports the effectiveness of the treatment Leg Stretching Using an Exoskeleton on Demand for spasticity?

Research shows that stretching can help reduce spasticity (muscle stiffness) and improve movement. An intelligent stretching device for ankles has been effective in increasing range of motion and reducing stiffness, suggesting that similar exoskeleton technology might help with leg spasticity. ^{2 4 5 6 7}

Who Is on the Research Team?

Steven W Brose

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can give consent and share my age, gender, and neurological condition.

I am a veteran with muscle stiffness from a spinal injury that happened over 6 months ago.

Neurologically stable (>6 months post-SCI) and can wear the device and the sensors, provide written informed consent, and follow instruction

Exclusion Criteria

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

I haven't had hip or knee pain that limits my movement in the last 2-3 weeks.

I am not on medications that affect bone, muscle, heart, or have conditions causing high fever, BP, or heart rate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or phone)

Treatment

Participants use the wearable exoskeleton for leg stretching and walking experiments

24 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Leg Stretching Using an Exoskeleton on Demand

Trial Overview 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.

How Is the Trial Designed?

Group I: Robotic Exoskeleton Experimental Treatment 1 Intervention

All participants will be interfered with a wearable robotic exoskeleton.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Syracuse University

Collaborator

Trials

54

Recruited

118,000+

Published Research Related to This Trial

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The effects of stretching in spasticity: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feedback-controlled and programmed stretching of the ankle plantarflexors and dorsiflexors in stroke: effects of a 4-week intervention program. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Influence of posture and muscle length on stretch reflex activity in poststroke patients with spasticity. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Intelligent stretching of ankle joints with contracture/spasticity. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Influences of muscle stretch reflexes on voluntary, velocity-controlled movements in spastic paraparesis. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Supplemental Stimulation Improves Swing Phase Kinematics During Exoskeleton Assisted Gait of SCI Subjects With Severe Muscle Spasticity. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Computational modeling of neuromuscular response to swing-phase robotic knee extension assistance in cerebral palsy. [2021]