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Exoskeleton

Robot-assisted Training with the H2 Exoskeleton for Stroke (H2-NeuroExo Trial)

N/A

Waitlist Available

Led By Gerard E Francisco, MD

Research Sponsored by University of 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 baseline, post-intervention (within a week of completion), follow-up at 2 weeks, follow-up at 2 months

Awards & highlights

H2-NeuroExo Trial Summary

This trial will compare the use of a smart lower limb robotic exoskeleton for rehabilitation after stroke with supervised motor practice. Additionally, it will examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain wave patterns associated with learning to walk on the powered lower limb exoskeleton.

Eligible Conditions

Stroke
Hemiparesis

H2-NeuroExo Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (within a week of completion), follow-up at 2 weeks, follow-up at 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (within a week of completion), follow-up at 2 weeks, follow-up at 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (within a week of completion), follow-up at 2 weeks, follow-up at 2 months 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 from baseline in Fugl-Meyer Assessment - Lower Extremity Motor Function

Change from baseline in Functional Gait Assessment

Change from baseline in Lower limb joint kinematics during walking

+1 more

Secondary outcome measures

Change from baseline in Berg Balance Scale score

Change from baseline in Timed Up and Go Test score

Change from baseline in distance walked during the 6-minute walk test

+1 more

H2-NeuroExo Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Robot-assisted RehabilitationExperimental Treatment1 Intervention

Participants will receive Robot-assisted training with the H2 lower limb powered exoskeleton. They will perform walking and other lower limb exercises (as applicable) while wearing the H2 lower limb powered exoskeleton. Training will involve 3 sessions per week for 4 weeks, each lasting about 1.5 hours.

Group II: Supervised motor practiceActive Control1 Intervention

Participants in this group will perform walking and other lower limb exercises (as applicable) under the supervision of a research physical therapist. Training will be for 3 sessions per week for 4 weeks, each session lasting about 1.5 hours.

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Who is running the clinical trial?

TIRR Memorial HermannOTHER

15 Previous Clinical Trials

4,695 Total Patients Enrolled

5 Trials studying Stroke

164 Patients Enrolled for Stroke

The University of Texas Health Science Center, HoustonOTHER

903 Previous Clinical Trials

320,917 Total Patients Enrolled

42 Trials studying Stroke

7,347 Patients Enrolled for Stroke

University of HoustonLead Sponsor

147 Previous Clinical Trials

47,492 Total Patients Enrolled

5 Trials studying Stroke

83 Patients Enrolled for Stroke

Media Library

H2 Lower Limb Exoskeleton (Exoskeleton) Clinical Trial Eligibility Overview. Trial Name: NCT02114450 — N/A

Stroke Research Study Groups: Supervised motor practice, Robot-assisted Rehabilitation

Stroke Clinical Trial 2023: H2 Lower Limb Exoskeleton Highlights & Side Effects. Trial Name: NCT02114450 — N/A

H2 Lower Limb Exoskeleton (Exoskeleton) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02114450 — N/A

Stroke Patient Testimony for trial: Trial Name: NCT02114450 — N/A

Frequently Asked Questions

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

What prerequisites must one satisfy in order to be a participant of this experiment?

"Currently, sixty individuals with hemiparesis between the ages of 18 and 75 are being admitted to this trial. Candidates must possess a passive range of motion in their hip (90° flexion/ 15-20° extension), knee (90° flexion/ full extension) and ankle (15° dorsiflexion/ 15 plantarflexion). Study participants should have had a stroke subacutely or chronically (3 months post-stroke for the former; 6 months post-stroke for the latter). Furthermore, they need to be able to stand with an assistive device for at least 5 minutes and walk 10 metres"

Answered by AI

What are the major goals of this trial?

"The main objective of this clinical trial, spanning a four week period, is to measure the evolution in Functional Gait Assessment from baseline. Secondary outcomes such as changes in robotic assistance during locomotion with the H2 device and distance walked over 6 minutes will also be monitored. Lastly, Berg Balance Scale scores are used to assess static balance and potential fall risk amongst enrolled patients."

Answered by AI

Is there still availability for patients to participate in this clinical trial?

"Affirmative. The details posted on clinicaltrials.gov suggest that this experiment is currently seeking participants, having been first published in November 2015 and updated most recently on the 23rd of November 2021. 60 test subjects are required from two separate medical sites."

Answered by AI

Does this clinical research include participants aged 45 and over?

"This medical research is targeting adults aged 18-75 who wish to participate."

Answered by AI

How many participants have signed up for this research endeavor?

"Affirmative. The information on clinicaltrials.gov indicates that the trial is actively enrolling participants, commencing from its original post date of November 20th 2015 and most recently updated on November 23rd 2021. Sixty patients are needed to be recruited amongst 2 centres for this study."

Answered by AI