Human-Machine System for the H2 Lower Limb Exoskeleton
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Houston
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Robot-assisted training with the H2 lower limb powered exoskeleton
BehavioralThe 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.
Supervised motor practice
BehavioralSupervised 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Robot-assisted RehabilitationExperimental treatment 1 intervention
Group B: Supervised motor practiceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in Fugl-Meyer Assessment - Lower Extremity Motor Function
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.
Time frame
Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months2
Change from baseline in Functional Gait Assessment
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.
Time frame
Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months3
Change from baseline in Lower limb joint kinematics during walking
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.
Time frame
Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months4
Change in cortical dynamics measured by Electroencephalography (EEG)
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.
Time frame
Each Experimental/Training Session (12 visits) over the 4 week training periodSecondary outcomes
1
Change in robotic measure of performance measured by the H2
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.
Time frame
Each Experimental/Training Session (12 visits) over the 4 week training period2
Change from baseline in Berg Balance Scale score
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.
Time frame
Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months3
Change from baseline in distance walked during the 6-minute walk test
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.
Time frame
Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months4
Change from baseline in Timed Up and Go Test score
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.
Time frame
Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 monthsSponsors and contacts
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University of Houston
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborator
TIRR Memorial Hermann
Collaborator
Source ClinicalTrials.gov