💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Robot-assisted training with the H2 lower limb powered exoskeleton
- Supervised motor practice
TIRR Memorial Hermann Hospital
Houston, United States
University of Houston
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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