RecruitingNot ApplicableNCT02114450

Human-Machine System for the H2 Lower Limb Exoskeleton

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


Sponsor

University of Houston

Enrollment

60 participants

Start Date

Nov 20, 2015

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

  • 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;
  • 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);
  • Modified Rankin scale scores 2-4 (Mild-Moderate functional disability post-stroke);
  • Modified Ashworth Scale of Spasticity score <= 2 (ranges from 0-4 with 4 reflecting maximum spasticity);
  • Have no skin integrity issues;
  • 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);
  • 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.
  • Able to understand and sign the consent form
  • Age 18-75 years

Exclusion Criteria9

  • Severe cognitive and/or visual deficit;
  • Hemineglect (determined based on medical record or initial clinical assessment);
  • Severe sensory deficit;
  • Joint contractures of any extremity that limits normal range of motion during ambulation with assistive devices;
  • Skin lesions that may hinder or prevent the application of exoskeleton;
  • Uncontrolled angina;
  • Severe chronic obstructive pulmonary disease;
  • Other medical contraindications; any medical co-morbidities that would prevent standard rehabilitation.
  • \- History of neurological, neuromuscular or physical disability.

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Interventions

BEHAVIORALRobot-assisted training with the H2 lower limb powered exoskeleton

The H2 is a powered, robotic lower limb exoskeleton with actuated hips, knees and ankles. A custom control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.

BEHAVIORALSupervised motor practice

Supervised motor practice involves lower limb rehabilitation, primarily walking and other applicable lower limb exercises performed by participants under the guidance and supervision of a research physical therapist.


Locations(2)

TIRR Memorial Hermann Hospital

Houston, Texas, United States

University of Houston

Houston, Texas, United States

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NCT02114450


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