Indego™ Exoskeleton for Spinal Cord Injury

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: James J. Peters Veterans Affairs Medical Center

Must not be taking: Tricyclics, Amphetamines, Neuroleptics, others

Disqualifiers: Neurological injury, Severe disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an exoskeleton device designed to help individuals with spinal cord injuries improve seated balance and overall body health. Participants will use the device to assist with walking, engaging muscles and balance in ways that a wheelchair does not. It targets individuals who have had a spinal cord injury for at least six months, rely on a wheelchair for mobility, and cannot walk independently. If successful, the Indego™ exoskeleton could become a valuable tool both at home and in clinical settings. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance mobility options for those with spinal cord injuries.

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

The trial does not specify if you need to stop taking your current medications. However, if you are using medications that significantly lower the seizure threshold, like certain antidepressants or stimulants, you may not be eligible to participate.

What prior data suggests that the Indego™ exoskeleton is safe for spinal cord injury patients?

Research has shown that the Indego™ exoskeleton is generally safe for people with spinal cord injuries. A study conducted at five locations found that this robotic device helps individuals stand and walk safely, even if they cannot walk independently. Some users experienced minor issues like skin redness or bruising, but these were not serious. Another study found that users could walk faster and more independently, both indoors and outdoors, while using the exoskeleton. Overall, current evidence suggests that the Indego™ exoskeleton is a well-tolerated option for improving mobility in people with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Indego™ Exoskeleton for spinal cord injury because it offers a novel approach to rehabilitation. Unlike traditional therapies that mainly focus on physical therapy and assistive devices like wheelchairs, the Indego™ Exoskeleton is a wearable, powered device that helps individuals with spinal cord injuries walk again. It provides a unique form of mobility and physical activity, which can improve muscle strength and cardiovascular health. The exoskeleton also offers the potential for enhanced neuroplasticity, which might aid in nerve healing and functional recovery. This combination of physical support and potential long-term health benefits sets Indego™ apart from current treatment options.

What evidence suggests that the Indego™ exoskeleton is effective for improving seated balance in individuals with spinal cord injury?

Research shows that devices like the Indego™ exoskeleton can improve mobility for people with spinal cord injuries (SCI). In this trial, participants will receive supervised EAW training using the Indego™ exoskeleton. Studies have found that the Indego™ is safe and effective for enabling individuals with SCIs to stand and walk independently. Early results suggest that using the Indego™ for walking practice might also help the brain form new connections, potentially reducing problems associated with SCI. Overall, current evidence suggests that the Indego™ exoskeleton could significantly enhance balance and movement for people with SCI. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people with spinal cord injury (SCI) who have had it for at least 6 months, use a wheelchair indoors and outdoors, can hold crutches, and have an SCI level of T4 or below. They must be able to consent and not have certain health issues like severe spasticity, low bone density in the knee, or conditions that increase seizure risk.

Inclusion Criteria

My spinal cord injury is at T4 level or lower and may be complete or incomplete.

I can use crutches with or without special adjustments.

Able to provide informed consent

Exclusion Criteria

I had a severe leg injury in the last 2 years.

I've had a low impact fracture in my leg since my spinal cord injury.

My joint cannot fully straighten, making it unsuitable for the device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 36 sessions of exoskeleton-assisted walking (EAW) training using Indego™ over 12 weeks

12 weeks

3 to 4 sessions per week, 4-6 hours per week

Follow-up

Participants are monitored for changes in seated balance and body composition after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Indego™

Trial Overview The study tests if training with the Indego™ Exoskeleton improves seated balance in individuals with SCI. Participants will undergo 36 sessions over 12 weeks to see if this device helps them sit more independently by challenging their balance while standing during therapy.

How Is the Trial Designed?

Group I: Exoskeleton Users Experimental Treatment 1 Intervention

All participants will receive 36 sessions of supervised EAW training using Indego™ for 12 weeks (3 to 4 sessions per week, 4-6 hours per week). The goal is to complete all 36 sessions in 12 weeks, but allowing for a two-week carryover to accommodate schedule conflicts or missed sessions.

Who Is Running the Clinical Trial?

James J. Peters Veterans Affairs Medical Center

Lead Sponsor

Trials

59

Recruited

2,900+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29434463/

Initial Outcomes from a Multicenter Study Utilizing the ... The Indego was shown to be safe for providing upright mobility to 32 individuals with SCIs who were nonambulatory.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02202538

Indego® Exoskeleton; Assessing Mobility for Persons With ... This study will evaluate the Indego® device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02793635

Study Details | NCT02793635 | Indego Exoskeleton After SCI The purpose of this study is to assess the use of Indego as a gait training tool for subjects with complete or incomplete paraplegia as a result of spinal cord ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4568090/

Mobility Outcomes Following Five Training Sessions with a ... This study was conducted to evaluate mobility outcomes for individuals with SCI after 5 gait-training sessions with a powered exoskeleton.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875024001906

Exoskeleton-Assisted Rehabilitation and Neuroplasticity in ... Exoskeleton serves as an emerging and promising tool for rehabilitation, especially in promoting neuroplasticity and alleviating SCI-related complications.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02202538?term=indego&aggFilters=status:&viewType=Table&rank=1&tab=results

Study Results | Indego® Exoskeleton; Assessing Mobility ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. frontiersin.org frontiersin.org/journals/neurorobotics/articles/10.3389/fnbot.2022.848443/full

Frontiers | Safety and Feasibility of a Novel Exoskeleton for ... Initial outcomes from a multicenter study utilizing the indego powered exoskeleton in spinal cord injury. Top Spinal Cord Inj. Rehabil. 24 ...

8. news.shepherd.org news.shepherd.org/researchers-find-indego-robotic-exoskeleton-is-safe-and-effective-for-assisting-standing-and-walking-in-some-people-with-paralysis/

Researchers Find Indego® Robotic Exoskeleton is Safe ... A five-site clinical trial of a robotic exoskeleton shows the device is safe and effective in assisting standing and walking in persons with ...