| Trial name or title |
Human‐machine system for the H2 lower limb exoskeleton (H2‐NeuroExo) |
| Methods |
RCT with 2 arms |
| Participants |
Inclusion criteria
Subacute or chronic stroke, i.e. interval of at least 3 months or at least 6 months from stroke to time of enrolment, 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 to 4 (mild‐moderate functional disability poststroke) Modified Ashworth Scale of Spasticity score ≤ 2 (range 0 to 4, with 4 reflecting maximum spasticity) Have no skin integrity issues Sufficient passive range of motion at the hip (at least 90° flexion, 15° to 20° extension), knee (90° flexion, complete extension), and ankle (15° dorsiflexion, 15° plantar flexion) 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 metres
Exclusion criteria
Severe cognitive or visual deficit, or both Hemineglect (determined based on medical record or initial clinical assessment) Severe sensory deficit Joint contractures of any extremity that limit 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 comorbidities that would prevent standard rehabilitation
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| Interventions |
Experimental: robot‐assisted rehabilitation participants will receive robot‐assisted training with the H2 lower limb powered exoskeleton. They will perform walking and other lower limb exercises (as applicable) while wearing the H2 lower limb powered exoskeleton. Training will involve 3 sessions per week for 4 weeks, each lasting about 1.5 hours.
Control: supervised motor practice participants will perform walking and other lower limb exercises (as applicable) under the supervision of a research physical therapist. Training will involve 3 sessions per week for 4 weeks, each lasting about 1.5 hours. |
| Outcomes |
Primary outcome measures
Change from baseline in Fugl‐Meyer Assessment Lower Extremity Functional Gait Assessment Lower limb joint kinematics during walking Cortical dynamics measured by electroencephalography
Secondary outcome measures
Robotic measure of performance measured by the H2 Berg Balance Scale score Distance walked during the 6‐minute walk test Timed Up and Go Test score
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| Starting date |
March 2014 |
| Contact information |
clinicaltrials.gov/ct2/show/study/NCT02114450#contacts |
| Notes |
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