Human-Machine System for the H2 Lower Limb Exoskeleton
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Houston
About this trial
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 criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Robot-assisted training with the H2 lower limb powered exoskeleton
- Supervised motor practice
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Houston
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborator
TIRR Memorial Hermann
Collaborator
Source ClinicalTrials.gov