Human-Machine System for the H2 Lower Limb Exoskeleton

Launched by UNIVERSITY OF HOUSTON · Apr 10, 2014

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a smart robotic device called a lower limb exoskeleton to help people recovering from a stroke. The study will compare how effective this robotic assistance is against traditional therapy where a therapist guides the patient through exercises. Researchers are also interested in understanding brain activity during the rehabilitation process by using a safe and painless method called electroencephalography (EEG), which measures brain waves. The goal is to improve how these robots interact with users and to potentially create devices that can be controlled by thought, helping those who have difficulty walking due to stroke.

To be part of this study, participants should be between the ages of 65-74 or 27-39 and have experienced a stroke at least three months prior. They must be able to understand the study and actively participate in treatments. Key requirements include having mild to moderate difficulties in daily activities and the ability to stand and walk with some support. Those with severe cognitive issues, significant movement limitations, or certain medical conditions may not be eligible. If you join, you can expect to engage in rehabilitation sessions using the exoskeleton, helping researchers learn how best to support recovery in stroke patients.

Gender

ALL

Eligibility 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.