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

N/A

Recruiting

Led By Jose L Contreras-Vidal, PhD

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

No Placebo-Only Group

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.

Who is the study for?

This trial is for adults aged 18-75 who've had a stroke at least 3 months ago, can stand and walk with assistance, have mild to moderate disability, normal cognitive ability (score >24 on Mini Mental State Exam), and controlled muscle stiffness. It's not for those with severe cognitive/visual deficits, other medical issues preventing rehab, severe sensory loss or joint contractures affecting walking.

What is being tested?

The study tests a smart robotic exoskeleton against supervised motor practice in post-stroke rehabilitation. It also examines brain wave patterns via EEG to potentially control orthotic devices by thought for improved human-robot interaction in walking assistance.

What are the potential side effects?

Potential side effects are not explicitly mentioned but may include discomfort from wearing the exoskeleton, skin irritation where it attaches, fatigue during training sessions, and possible strain on muscles or joints.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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