Indego™ Exoskeleton for Spinal Cord Injury

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: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Exoskeleton-assisted walking (EAW) provides a new mobility option and appears to have potential therapeutic benefits for persons with SCI. However, present day technology is not sufficient to replace the wheelchair. During EAW, users stand upright, maintain static and dynamic balance by actively and passively stimulating trunk and lower limb muscles in a manner not challenged during wheelchair use. Preliminary results in our laboratory suggest that the indirect balance challenges and postural perturbations that result during EAW training transfer to better seated balance control, resulting in more independence during seated activities. The purpose of this pilot study is to determine the effects of EAW training on various measures of seated balance (primary outcomes) and body composition (secondary outcomes). Twenty people with SCI (T4 and below) who are wheelchair users for mobility and cannot walk independently will be recruited. The participants will receive 36 sessions of EAW training in 12 weeks. The outcomes will be evaluated pre (baseline) and post (24 and 36 sessions). If EAW devices can be demonstrated to help people with SCI have better seated balance, in addition to the other potential benefits that are being investigated elsewhere, then exoskeletons may have the possibility to be more readily accepted in the clinical, home environments, and by the insurance companies.

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+