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Exoskeleton

Indego™ Exoskeleton for Spinal Cord Injury

N/A

Recruiting

Research Sponsored by James J. Peters Veterans Affairs Medical Center

Eligibility Criteria Checklist

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

Must have

Level and completeness of injury T4 and below with complete or incomplete SCI (ISNCSCI A to D)

Traumatic or non-traumatic SCI ≥6 months duration of SCI

Must not have

Traumatic or high impact lower extremity fracture within the past 2 years

Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline after 8 weeks and after 12 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using an exoskeleton to walk can help people with spinal cord injuries improve their balance while seated, as well as other benefits.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for this intervention, potential risks may include muscle fatigue due to new activity levels, skin irritation from the device contact points, or discomfort associated with adapting to the exoskeleton.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have had a spinal cord injury for at least 6 months.

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I use a wheelchair for moving around both indoors and outdoors.

Exclusion Criteria

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

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

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

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

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My foot fracture has been confirmed by both x-ray and CT scan.

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I cannot move my ankle fully even with support.

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My condition is worsening and affecting my brain or nerves.

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My condition is a neurological injury that is not spinal cord injury.

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I have a history of stroke, brain tumor, brain abscess, or multiple sclerosis.

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My blood pressure is not higher than 140/90 mmHg.

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I have had seizures in the past.

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I have a current pressure sore on my body.

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I am not taking medications that greatly increase my risk of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline after 8 weeks and after 12 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline after 8 weeks and after 12 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline after 8 weeks and after 12 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

Seated Computerized Dynamic Posturography (sCDP)

Secondary study objectives

Motor Evoked Potentials (MEPs)

Seated Activities of Daily Living (ADLs)

Other study objectives

Spinal Cord Independence Measure (SCIM)

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: Exoskeleton UsersExperimental Treatment1 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.

0 / 15Eligibility criteria met