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Human-Machine System for the H2 Lower Limb Exoskeleton

University of Houston · with The University of Texas Health Science Center, Houston, TIRR Memorial Hermann · NCT02114450

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
1
Study start
November 20, 2015
Record last updated
October 30, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Robot-assisted training with the H2 lower limb powered exoskeleton; Supervised motor practice

Conditions: Stroke; Hemiparesis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Inclusion criteria for healthy, able-bodied participants:

  • Able to understand and sign the consent form
  • Age 18-75 years

Exclusion criteria for healthy, able-bodied participants:

  • History of neurological, neuromuscular or physical disability.

Recruiting US locations

  • University of Houston

    Houston, TX 77204

    Site contact: Jose L Contreras-Vidal, PhD · 713-743-4429 · jlcontreras-vidal@uh.edu

Study contacts (from the official record)

  • Jose L Contreras-Vidal, PhD · 713-743-4429 · jlcontreras-vidal@UH.EDU
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Human-Machine System for the H2 Lower Limb Exoskeleton (NCT02114450) | Bored Studies