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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
United States
Texas
TIRR Memorial Hermann Hospital
NOT_YET_RECRUITING
Houston
University of Houston
RECRUITING
Houston
Contact Information
Primary
Jose L Contreras-Vidal, PhD
jlcontreras-vidal@UH.EDU
713-743-4429
Time Frame
Start Date: 2015-11-20
Estimated Completion Date: 2029-12
Participants
Target number of participants: 60
Treatments
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.
Active_comparator: Supervised motor practice
Participants in this group will perform walking and other lower limb exercises (as applicable) under the supervision of a research physical therapist. Training will be for 3 sessions per week for 4 weeks, each session lasting about 1.5 hours.
Authors
Jose L Contreras-Vidal, Gerard E Francisco
Related Therapeutic Areas
Sponsors
Collaborators: The University of Texas Health Science Center, Houston, TIRR Memorial Hermann
Leads: University of Houston

This content was sourced from clinicaltrials.gov