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Robotic Gait Training for Spinal Cord Injury (FIRST Trial)

N/A

Waitlist Available

Led By Chad D Swank, PhD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

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

Must have

All types of incomplete Spinal Cord Injury (SCI) (traumatic and non-traumatic)

Acute/Subacute phase of recovery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within one week before discharge

Awards & highlights

FIRST Trial Summary

This trial is testing if a robotic gait training device can help people with spinal cord injuries learn to walk again.

Eligible Conditions

Spinal Cord Injury

FIRST Trial Eligibility Criteria

Inclusion Criteria

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

Select...

You have an incomplete spinal cord injury, which includes both traumatic and non-traumatic injuries.

Select...

You are currently in the early stages of recovering from an injury or illness.

FIRST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following every treatment session until discharge, an average of 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately following every treatment session until discharge, an average of 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following every treatment session until discharge, an average of 28 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Spinal Cord

Secondary outcome measures

Fatigue Severity Scale (FSS)

Gait speed via 10-Meter Walk Test (10MWT)

Anxiety Disorders

+9 more

FIRST Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Robotic Gait TrainingExperimental Treatment1 Intervention

Patients in the Robotic Gait Training (RGT) group will receive 90 minutes per week of RGT once patients are deemed clinically appropriate as defined by being able to tolerate standing for 15 minutes without orthostatic intolerance. The duration of treatment will span the patient's length of stay in inpatient rehabilitation. The Ekso Bionics Ekso GT™ robotic exoskeleton will be used for RGT.

Group II: Usual Care Gait TrainingActive Control1 Intervention

Usual Care (UC) gait training including body weight-supported treadmill training (BWSTT) and conventional overground walking.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED

71 Previous Clinical Trials

9,001 Total Patients Enrolled

Baylor Research InstituteLead Sponsor

200 Previous Clinical Trials

203,293 Total Patients Enrolled

Chad D Swank, PhDPrincipal InvestigatorBSWRI

Frequently Asked Questions

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

Is the target demographic for this research project individuals aged 40 or above?

"This trial has stringent age requirements, as only patients between 16 and 70 years of age are eligible to participate."

Answered by AI

How many participants are engaged in this research endeavor?

"Indeed, the data hosted on clinicaltrials.gov affirms that this research initiative, which was first announced on April 12th 2021, is actively seeking applicants. There is a need for 128 individuals to be recruited from 1 site in total."

Answered by AI

Are recruitment efforts currently underway for this trial?

"Affirmative. According to clinicaltrials.gov, this research trial is currently accepting volunteers; it was published on April 12th 2021 and last updated June 30th 2021. The team seeks 128 people at one site for the study."

Answered by AI

Am I qualified to participate in this clinical trial?

"Eligibility criteria for this trial necessitates that prospective patients have spinal cord injuries and be between 16 to 70 years old. The number of participants being sought after is 128 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Foundational Ingredients of Robotic Gait Training for People With Spinal Cord Injury During Inpatient Therapy

Chad Swank 2021. "Foundational Ingredients of Robotic Gait Training for People With Spinal Cord Injury During Inpatient Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04781621.

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