Human-Machine System for the H2 Lower Limb Exoskeleton "H2-NeuroExo"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

Stroke is the leading cause of neurological disability in the United States and accounts for the poor physical health and the social dysfunction evident in survivors. Gait impairment is a large contributor to long-term disability and ambulatory function in daily living. Many patients, however, lose the ability to walk independently, and furthermore, a large proportion does not regain their normal walking speeds following a stroke. In this context, newer robotic-aided therapeutic tools such as "wearable" lower-limb robotic exoskeletons have been developed, which allow for the user to be augmented by mechanically actuated lower limb joints that can either completely or partially assist movements of the lower limb segments depending on the patient needs.
The H2 exoskeleton (developed by Technaid S.L., Spain) is an example of one such system that has hip, knee and ankle joints actuated for both lower limbs. These devices are very new, and therefore, systematic investigations of therapeutic benefits of these devices are lacking in the field. Further, the nature of plasticity in the brain triggered by wearing and training such exoskeletons is unknown. In this exploratory research study, the investigators aim to compare robotic-assisted rehabilitation using the H2 exoskeleton with supervised motor practice particularly in terms of functional recovery. Additionally, this study will also examine brain plasticity associated with robotic-assisted training using non-invasive scalp electroencephalography (EEG) and changes in lower limb joint kinematics during robotic-assisted training. Taken together, the findings from this research will be used to understand human-robot interaction and to design smart powered orthotic devices that can be controlled directly by brain activity and assist those that have lost all or part of their walking abilities due to neurological disease or injury. Moreover, this study will systematically track neuroplasticity associated with functional recovery after stroke, which will help determine optimal windows for treatment that would maximize therapeutic benefit. Lastly, it will also help characterize markers of learning to use these new devices, which will be important in the clinical setting for modifying and adapting rehabilitation protocols to suit changing needs of the patient (user).

Conditions

Interventions

  • Robot-assisted training with the H2 lower limb powered exoskeleton Behavioral
    Intervention Desc: The H2 is a powered, robotic lower limb exoskeleton with actuated hips, knees and ankles. A custom control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.
    ARM 1: Kind: Experimental
    Label: Robot-assisted Rehabilitation
    Description: 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.
  • Supervised motor practice Behavioral
    Intervention Desc: Supervised motor practice involves lower limb rehabilitation, primarily walking and other applicable lower limb exercises performed by participants under the guidance and supervision of a research physical therapist.
    ARM 1: Kind: Experimental
    Label: Supervised motor practice
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Basic Science
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in Fugl-Meyer Assessment - Lower Extremity Motor Function Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months No
Primary Change from baseline in Functional Gait Assessment Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months No
Primary Change from baseline in Lower limb joint kinematics during walking Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months No
Primary Change in cortical dynamics measured by Electroencephalography (EEG) Each Experimental/Training Session (12 visits) over the 4 week training period No
Secondary Change in robotic measure of performance measured by the H2 Each Experimental/Training Session (12 visits) over the 4 week training period No
Secondary Change from baseline in Berg Balance Scale score Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months No
Secondary Change from baseline in distance walked during the 6-minute walk test Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months No
Secondary Change from baseline in Timed Up and Go Test score Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months No

Sponsors