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Robotic Exoskeleton

Robotic Gait Training for Neurological and Musculoskeletal Injuries

N/A
Recruiting
Led By Shuo-Hsiu Chang, PT, PhD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one week before start of wre training, within 2 weeks after start of wre training
Awards & highlights

Study Summary

This trial will develop an algorithm to help patients with neurological conditions who are using a wearable robotic exoskeleton for gait training.

Eligible Conditions
  • Incomplete Spinal Cord Injury
  • Spinal Cord Injury
  • Acquired Brain Injury
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within one week before start of wre training, within 2 weeks after start of wre training
This trial's timeline: 3 weeks for screening, Varies for treatment, and within one week before start of wre training, within 2 weeks after start of wre training 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 energy expenditure as assessed by oxygen consumption during 10MWT without WRE
Change in energy expenditure as assessed by oxygen consumption during 6MWT without WRE
Change in gait kinematics as assessed by lower extremity joint angular velocities without WRE
+5 more
Secondary outcome measures
Amount of physical assistance needed for walking following paralysis resulted from SCI as assessed by Walking Index of Spinal Cord Injury (WISCI-II)
Bone mineral density as assessed by whole body scan
Change in H-reflex of soleus muscle as assessed by electromyography (EMG)
+17 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: ReWalk, then REX, then EKSOExperimental Treatment3 Interventions
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Group II: ReWalk, then EKSO, then REXExperimental Treatment3 Interventions
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Group III: REX, then ReWalk, then EKSOExperimental Treatment3 Interventions
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Group IV: REX, then EKSO, then ReWalkExperimental Treatment3 Interventions
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Group V: EKSO, then ReWalk, then REXExperimental Treatment3 Interventions
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Group VI: EKSO, then REX, then ReWalkExperimental Treatment3 Interventions
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ReWalk
2014
N/A
~20

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,902 Total Patients Enrolled
Shuo-Hsiu Chang, PT, PhDPrincipal Investigator - The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
1 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

EKSO (Robotic Exoskeleton) Clinical Trial Eligibility Overview. Trial Name: NCT03057652 — N/A
Spinal Cord Injury Research Study Groups: ReWalk, then EKSO, then REX, ReWalk, then REX, then EKSO, EKSO, then ReWalk, then REX, EKSO, then REX, then ReWalk, REX, then EKSO, then ReWalk, REX, then ReWalk, then EKSO
Spinal Cord Injury Clinical Trial 2023: EKSO Highlights & Side Effects. Trial Name: NCT03057652 — N/A
EKSO (Robotic Exoskeleton) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03057652 — N/A
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT03057652 — N/A

Frequently Asked Questions

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

Are there any available opportunities for participants in this research?

"According to the records published on clinicaltrials.gov, this medical trial is actively searching for new participants. This study was made public onMarch 1st 2016 and has seen updates as recently as May 19th 2022."

Answered by AI

What chief aims are being sought with this investigation?

"This research project, which will be assessed over the course of one week prior to and two weeks after WRE training implementation, seeks to ascertain energy output as measured by oxygen consumption during 10MWT without any personalised assistive devices. Secondary objectives include quantifying physical assistance needs following SCI through a Walking Index of Spinal cord injury (WISCI-II), computing energy expenditure while wearing WRE during 10MWT via Cosmed K4b2 portable metabolic system, and gauging cognitive impairment with Folstein Mini Mental State Examination."

Answered by AI

What is the enrollment capacity of this clinical study?

"Indeed, the data hosted on clinicaltrials.gov indicates that this current medical research is actively looking for volunteers to join their ranks. This project was posted online on March 1st 2016 and recently updated on May 19th 2022. The team aims to recruit 75 people amongst one trial site."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Texas
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
TIRR Memorial Hermann
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I've always been interested in the exoskeleton and would love to gain from it.
PatientReceived 1 prior treatment
I'm looking for trials to help with my gait and to help others with gait issues with findings from the trial.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 1 Day
Most responsive sites:
  1. TIRR Memorial Hermann: < 24 hours
Recent research and studies
Journal of Neural EngineeringJournal
Effects of an Exoskeleton-assisted Gait Training on Post-stroke Lower-limb Muscle Coordination
Zhu, Fangshi, Marcie Kern, Erin Fowkes, Taimoor Afzal, Jose-Luis Contreras-Vidal, Gerard E Francisco, and Shuo-Hsiu Chang. 2021. “Effects of an Exoskeleton-assisted Gait Training on Post-stroke Lower-limb Muscle Coordination”. Journal of Neural Engineering. IOP Publishing. doi:10.1088/1741-2552/abf0d5.
clinicaltrials.govStudy
Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
Shuo-Hsiu Chang 2016. "Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03057652.
~8 spots leftby Apr 2025
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