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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Seated Computerized Dynamic Posturography (sCDP)

Secondary outcome measures

Motor Evoked Potentials (MEPs)

Seated Activities of Daily Living (ADLs)

Other outcome measures

Spinal Cord Independence Measure (SCIM)

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor

57 Previous Clinical Trials

2,880 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count of this medical experiment?

"Affirmative. According to records on clinicaltrials.gov, this medical trial is currently accepting participants. It was first made available on February 1st 2018 and recently updated on September 26th 2023. The study requires 20 people from one site for enrolment."

Answered by AI

Does this medical experiment have openings for participants?

"Affirmative. The clinical trial website shows that this research is actively searching for volunteers, with the initial post dated February 1st 2018 and the most recent update on September 26th 2023. This project requires a total of 20 participants from one site to be enrolled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Seated Balance Using the Indego™

Ann M. Spungen, EdD 2018. "Seated Balance Using the Indego™". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04047992.

All > Spinal Cord Injury