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Exoskeleton-Assisted Walking for Spinal Cord Injury (HIT Exo IP Trial)

N/A

Recruiting

Led By Shuo-Hsiu (James) Chang

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

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

Must have

Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit

Able to achieve adequate fit within the exoskeleton

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre intervention (about 1 day prior to intervention) and 1 day after session 5 (about day 12)

Awards & highlights

HIT Exo IP Trial Summary

This trial will test if a wearable robotic exoskeleton can help people walk at a high intensity, which may improve their walking ability.

Who is the study for?

This trial is for individuals with motor incomplete spinal cord injury (AIS C or D) or stroke, who can stand and walk with an exoskeleton, weigh less than 220 pounds, and have intact skin where the device touches. It's not for pregnant women, those with unstable spines, unhealed fractures, severe other neurological injuries besides stroke or SCI, uncontrollable muscle stiffness or spasms, colostomy issues, cardiovascular problems that prevent standing up without fainting.Check my eligibility

What is being tested?

The study tests if high-intensity training using a wearable robotic exoskeleton (Ekso) can improve walking ability in people recovering from traumatic brain injury or spinal cord injury. Participants will undergo five sessions of walking training in the Ekso suit plus two additional assessments before and after these sessions to measure balance and endurance changes.See study design

What are the potential side effects?

While specific side effects are not listed for this intervention type as it's more physical therapy-oriented rather than drug-related; participants may experience fatigue due to exercise intensity and potential discomfort from wearing the exoskeleton.

HIT Exo IP Trial Eligibility Criteria

Inclusion Criteria

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

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I can walk normally and get up from or sit down in a chair without help.

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I can fit properly in the exoskeleton device.

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I have had a stroke or a spinal cord injury that allows me some movement.

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My skin is healthy where it touches the medical device.

HIT Exo IP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre intervention (about 1 day prior to intervention) and 1 day after session 5 (about day 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre intervention (about 1 day prior to intervention) and 1 day after session 5 (about day 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre intervention (about 1 day prior to intervention) and 1 day after session 5 (about day 12) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Fast Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)

Change in Self Selected Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)

Change in Walking Endurance as Assessed by the 6 Minute Walk Test (6MWT)

+2 more

Secondary outcome measures

Change in Metabolic Expenditure during 10MWT, as Assessed by Oxygen Consumption

Change in Metabolic Expenditure during 6MWT, as Assessed by Oxygen Consumption

Change in Seated Dynamic Reach as Assessed by the Modified Functional Reach Test

+7 more

HIT Exo IP Trial Design

1Treatment groups

Experimental Treatment

Group I: ExoskeletonExperimental Treatment1 Intervention

5 sessions of overground ambulation with wearable exoskeleton where heart rate is monitored over each session.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ekso

2014

N/A

~70

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,940 Total Patients Enrolled

Shuo-Hsiu (James) ChangPrincipal InvestigatorThe University of Texas Health Sciences Center at Houston

Frequently Asked Questions

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

What objectives are being pursued with this research?

"The primary aims of this trial, as evaluated during session 5 (around day 11), is to measure the alterations in Self-Selected Gait Speed via a 10 Meter Walk Test. Secondary goals comprising of Modified Functional Reach Test for seated dynamic reach and GAITRite pressure map's temporal-spatial gait parameters such as double support percentage and stride length should also be observed."

Answered by AI

Are patients being accepted into the trial at this time?

"Affirmative. According to the clinicaltrials.gov website, this clinical trial is recruiting participants as of now and was first posted on August 6th 2021. The last update occurred on January 5th 2022; 20 patients are needed from a single location for the study to reach completion."

Answered by AI

What is the aggregate number of participants in this experiment?

"Affirmative. Clinicaltrials.gov evidences that the trial is presently recruiting participants, which were first mentioned on 8/6/2021 and most recently updated on 1/5/2022. Subsequently, 20 test subjects will be enrolled from one medical site."

Answered by AI