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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wearable exoskeleton designed to help people with movement difficulties improve walking and leg function. Researchers aim to assess how this device affects muscle activity, joint motion, and overall walking ability. The trial seeks to enhance mobility and quality of life for those with movement challenges due to spinal cord injuries. Veterans with spasticity (muscle stiffness) from a spinal cord injury for more than six months and no other neurological conditions might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mobility for many.

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.

What prior data suggests that this exoskeleton is safe for improving leg function?

Earlier studies have shown that robotic exoskeletons aid rehabilitation, particularly after spinal cord injuries. They enhance movement by improving coordination and reducing muscle stiffness. One study found that using a robotic exoskeleton for exercises is safe and practical for long-term use, especially in programs lasting about 12 weeks. However, researchers are still studying the safety of exoskeletons that stretch the legs. While some exoskeletons have received approval for use, not all risks are fully understood. Past studies have generally found these devices well-tolerated, but ongoing research aims to better understand any potential issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of a leg-stretching exoskeleton for treating spasticity because it offers a novel approach compared to the standard physical therapy and medication options. Unlike traditional therapies that often rely on manual stretching or oral medications, this exoskeleton provides on-demand, precise mechanical assistance to stretch the leg muscles. This method could allow for more consistent and controlled stretching, potentially improving muscle flexibility and reducing spasticity more effectively. Plus, it may empower patients by giving them direct control over their therapy, which is a significant departure from the passive nature of many current treatments.

What evidence suggests that this exoskeleton is effective for improving leg function in movement disorders?

Research has shown that using an exoskeleton for leg stretching can reduce muscle stiffness and improve movement. In this trial, all participants will use a robotic exoskeleton. Studies have found that robotic exoskeletons enhance the coordination of leg movements and decrease muscle tightness. Other research suggests that stretching with an exoskeleton can improve the range of motion and walking pattern in people with movement disorders. Overall, exoskeletons have shown promise in enhancing muscle function and quality of life for those with neurological movement issues. ^{1 3 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. clinicaltrials.gov clinicaltrials.gov/study/NCT05926596

Leg Stretching Using an Exoskeleton on Demand for ... The purpose of this research study is to develop a protocol using a fully wearable, portable lower-limb exoskeleton for improving leg and walking function ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11118818/

Efficacy of a Soft Robotic Exoskeleton to Improve Lower Limb ... SRE-assisted walking training may help to enhance the coordination of lower limb movements, improve muscle spasticity, and normalize standing ...

3. withpower.com withpower.com/trial/phase-muscle-spasticity-9-2023-28717

Leg Stretching Exoskeleton for Spasticity Research shows that stretching can help reduce spasticity (muscle stiffness) and improve movement. An intelligent stretching device for ankles has been ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00815-5

Systematic review on wearable lower-limb exoskeletons for ... Gait disorders affect approximately 60% of patients with neuromuscular disorders [1] and generally have a high impact on their quality of life [ ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1651913/full

Protocol for the “stand the future” trial: robotic exoskeleton ... The primary outcome of this study will be gross motor function and walking capacity, assessed at baseline, middle-point, and after the 6-month intervention ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6153133/

Robotic exoskeletons: The current pros and cons - PMC Robotic exoskeletons have emerged as rehabilitation tool that may ameliorate several of the existing health-related consequences after spinal cord injury (SCI).

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00967-4

Physiotherapy using a free-standing robotic exoskeleton for ... This study has demonstrated that it is safe and practical to deliver a program of 12 weeks of weightbearing exercise in a free-standing lower ...