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Robotic Leg Exoskeleton Training for Walking After Stroke

Compares robot-assisted walking training with exoskeleton against supervised practice in adults after stroke.

Plain-language title generated from the registry record
Registry title: Human-Machine System for the H2 Lower Limb Exoskeleton

Key facts

Where
Houston, United StatesSee the 2 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT02114450, who can take part

Where in United States

  • TIRR Memorial Hermann HospitalHouston, United StatesNot yet recruiting
  • University of HoustonHouston, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Houston
Trial code
NCT02114450
Record updated
30 October 2024
Original 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.Read full original descriptionShow less

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

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.

Inclusion: 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: Uncontrolled angina; Severe chronic obstructive pulmonary disease; History of neurological, neuromuscular or physical disability; 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; Other medical contraindications; any medical co-morbidities that would prevent standard rehabilitation.

ClinicalTrials.gov NCT02114450