RECRUITING

Human-Machine System for the H2 Lower Limb Exoskeleton

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Human Machine Interface System with the H2 Lower Limb Exoskeleton for Rehabilitation

Quick Facts

Study Start:2015-11-20
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02114450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Sub-acute or chronic stroke i.e., interval of at least 3 months or interval of at least 6 months from stroke to time of enrollment, respectively;
  2. * Cognitive ability to assimilate and participate actively in the treatment protocol (Mini Mental State Examination score \> 24 points, out of a total 30 indicating normal cognitive ability);
  3. * Modified Rankin scale scores 2-4 (Mild-Moderate functional disability post-stroke);
  4. * Modified Ashworth Scale of Spasticity score \<= 2 (ranges from 0-4 with 4 reflecting maximum spasticity);
  5. * Have no skin integrity issues;
  6. * Sufficient passive range of motion at the hip (at least 90 deg flexion, 15-20 deg extension), knee (90 deg flexion, complete extension) and ankle (15 deg dorsiflexion, 15 deg plantarflexion);
  7. * Have no contraindications to standing or walking; able to stand with assistive device for at least 5 minutes, and able to walk with assistive device for 10 m.
  1. * Severe cognitive and/or visual deficit;
  2. * Hemineglect (determined based on medical record or initial clinical assessment);
  3. * Severe sensory deficit;
  4. * Joint contractures of any extremity that limits normal range of motion during ambulation with assistive devices;
  5. * Skin lesions that may hinder or prevent the application of exoskeleton;
  6. * Uncontrolled angina;
  7. * Severe chronic obstructive pulmonary disease;
  8. * Other medical contraindications; any medical co-morbidities that would prevent standard rehabilitation.
  9. * Able to understand and sign the consent form
  10. * Age 18-75 years

Contacts and Locations

Study Contact

Jose L Contreras-Vidal, PhD
CONTACT
713-743-4429
jlcontreras-vidal@UH.EDU

Principal Investigator

Jose L Contreras-Vidal, PhD
PRINCIPAL_INVESTIGATOR
University of Houston
Gerard E Francisco, MD
PRINCIPAL_INVESTIGATOR
TIRR Memorial Hermann Hospital
Jose L Pons, PhD
PRINCIPAL_INVESTIGATOR
Spanish Research Council

Study Locations (Sites)

TIRR Memorial Hermann Hospital
Houston, Texas, 77056
United States
University of Houston
Houston, Texas, 77204
United States

Collaborators and Investigators

Sponsor: University of Houston

  • Jose L Contreras-Vidal, PhD, PRINCIPAL_INVESTIGATOR, University of Houston
  • Gerard E Francisco, MD, PRINCIPAL_INVESTIGATOR, TIRR Memorial Hermann Hospital
  • Jose L Pons, PhD, PRINCIPAL_INVESTIGATOR, Spanish Research Council

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-11-20
Study Completion Date2029-12

Study Record Updates

Study Start Date2015-11-20
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • Stroke
  • Paresis
  • Gait rehabilitation
  • Human-Machine Interaction
  • Wearable Robotic Devices

Additional Relevant MeSH Terms

  • Stroke
  • Hemiparesis