Human-Machine System for the H2 Lower Limb Exoskeleton (H2-NeuroExo)
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|ClinicalTrials.gov Identifier: NCT02114450|
Recruitment Status : Recruiting
First Posted : April 15, 2014
Last Update Posted : November 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiparesis||Behavioral: Robot-assisted training with the H2 lower limb powered exoskeleton Behavioral: Supervised motor practice||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Human Machine Interface System With the H2 Lower Limb Exoskeleton for Rehabilitation|
|Actual Study Start Date :||November 20, 2015|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
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.
Behavioral: Robot-assisted training with the H2 lower limb powered exoskeleton
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.
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.
Behavioral: Supervised motor practice
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.
- Change from baseline in Fugl-Meyer Assessment - Lower Extremity Motor Function [ Time Frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months ]This test evaluates and measures recovery in post-stroke hemiplegic patients, used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the Balance component of the F-M scale (0;con not perform; 1:can perform partially; 2:can perform fully). The total score ranges from 0 to 34, with higher scores representing better function.
- Change from baseline in Functional Gait Assessment [ Time Frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months ]This scale assesses postural stability during various walking tasks using a 10-item test with each item scored from 0 to 3 (0 = severe impairment and 3 = normal ambulation). This test has high criterion validity to assess functional status in stroke patients, and has been shown to be responsive to measure change.
- Change from baseline in Lower limb joint kinematics during walking [ Time Frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months ]Lower limb joint kinematics (bilateral hip, knee and ankle joints) will be assessed through surface motion sensors placed on the skin during walking. This assessment will help study and characterize subtle changes in lower limb kinematics pre- and post-intervention.
- Change in cortical dynamics measured by Electroencephalography (EEG) [ Time Frame: Each Experimental/Training Session (12 visits) over the 4 week training period ]Time and frequency domain analysis will be performed on scalp EEG signals to characterize changes in cortical dynamics, specifically in gait initiation and sensory-motor cortical networks. Additionally, we will also evaluate the extent to which lower limb kinematics during gait can be reconstructed from scalp EEG of the user. This will be used to evaluate the neural basis of changes in lower limb joint motion as well as develop EEG-based brain-machine interfaces to robotic exoskeletons.
- Change in robotic measure of performance measured by the H2 [ Time Frame: Each Experimental/Training Session (12 visits) over the 4 week training period ]The amount of assistance provided by robotic joint motors will be monitored across treatment sessions. This will help better understand human-robotic interaction while walking with the H2, and also help characterize changes in human adaptation while using the device.
- Change from baseline in Berg Balance Scale score [ Time Frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months ]A 14-item objective measure designed to assess static balance and fall risk in adult populations, with maximum summed score of 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability.
- Change from baseline in distance walked during the 6-minute walk test [ Time Frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months ]This test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. It has good responsiveness to detect improvements in capacity to walk in stroke patients.
- Change from baseline in Timed Up and Go Test score [ Time Frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months ]This test assesses mobility, balance, walking ability, and fall risk in older adults. Scores range from 1 to 5 based on the observer's perception of the patient's risk of falling. This test has been used in assessing stroke recovery with high reliability and validity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114450
|Contact: Jose L Contreras-Vidal, PhD||713-743-4429||jlcontreras-vidal@UH.EDU|
|United States, Texas|
|TIRR Memorial Hermann Hospital||Not yet recruiting|
|Houston, Texas, United States, 77056|
|Contact: Gerard E Francisco, MD 713-797-5244 email@example.com|
|Contact: Shuo-Hsiu Chang, PT, PhD 713-799-7016 Shuo-Hsiu.Chang@uth.tmc.edu|
|Principal Investigator: Gerard E Francisco, MD|
|Sub-Investigator: Shuo-Hsiu Chang, PT, PhD|
|University of Houston||Recruiting|
|Houston, Texas, United States, 77204|
|Contact: Jose L Contreras-Vidal, PhD 713-743-4429 firstname.lastname@example.org|
|Principal Investigator: Jose L Contreras-Vidal, PhD|
|Principal Investigator:||Jose L Contreras-Vidal, PhD||University of Houston|
|Principal Investigator:||Gerard E Francisco, MD||TIRR Memorial Hermann Hospital|
|Principal Investigator:||Jose L Pons, PhD||Spanish Research Council|