Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT02114450

Human-Machine System for the H2 Lower Limb Exoskeleton

Led by University of Houston · Updated on 2024-10-30

60

Participants Needed

2

Research Sites

732 weeks

Total Duration

On this page

Sponsors

U

University of Houston

Lead Sponsor

T

The University of Texas Health Science Center, Houston

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research study will investigate the use of smart lower limb robotic exoskeleton (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also 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. The findings will be used to understand human-robot interaction and to design smart orthotic devices that can be controlled by thought activity and assist those that have lost all or part of their walking abilities.

CONDITIONS

Official Title

Human-Machine System for the H2 Lower Limb Exoskeleton

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Sub-acute or chronic stroke with interval of at least 3 months or 6 months from stroke to enrollment
  • Cognitive ability to participate actively (Mini Mental State Examination score > 24 out of 30)
  • Modified Rankin scale scores 2-4 indicating mild to moderate functional disability
  • Modified Ashworth Scale of Spasticity score of 2 or less
  • No skin integrity issues
  • Sufficient passive range of motion at hip, knee, and ankle joints
  • No contraindications to standing or walking; able to stand with assistive device for 5 minutes and walk 10 meters with assistive device
  • Healthy able-bodied participants must be aged 18 to 75 years and able to understand and sign consent form
Not Eligible

You will not qualify if you...

  • Severe cognitive and/or visual deficit
  • Hemineglect based on medical record or assessment
  • Severe sensory deficit
  • Joint contractures limiting normal range of motion during assisted walking
  • Skin lesions preventing exoskeleton use
  • Uncontrolled angina
  • Severe chronic obstructive pulmonary disease
  • Other medical conditions preventing standard rehabilitation
  • Healthy able-bodied participants with history of neurological, neuromuscular, or physical disability

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

TIRR Memorial Hermann Hospital

Houston, Texas, United States, 77056

Not Yet Recruiting

2

University of Houston

Houston, Texas, United States, 77204

Actively Recruiting

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Research Team

J

Jose L Contreras-Vidal, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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