An interventional study of Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain) and Conventional gait rehabilitation in Stroke, sponsored by Corporación de Rehabilitación Club de Leones Cruz del Sur. Completed at 1 site in Chile. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-16.
Sponsored by Corporación de Rehabilitación Club de Leones Cruz del Sur · Not applicable, Interventional, and Treatment
This research will study the effects of a rehabilitation program assisted by a powered lower extremity exoskeleton in patients after stroke. It will compare clinical and biomechanical features of patients at baseline and after intervention. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.
Stroke is one of the leading causes of mortality, morbidity and disability in adults in developed countries. Survivors may suffer several neurological deficits or deficiencies, such as hemiparesis, communication disorders, cognitive deficits and visuospatial perception disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain injury, usually resulting in alterations of the locomotor system with persistent disorders of movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an important objective in the rehabilitation program for stroke patients.The currently available treatment techniques include classical techniques of gait rehabilitation, functional electrical stimulation, electromechanic devices, robotic devices and brain-computer interfaces, among others.The evidence suggest that the combination of different rehabilitation strategies is more effective than conventional rehabilitation techniques alone. Technology-based rehabilitation methods such as robotic devices need more research to demonstrate their effects on gait recovery.
This study will assess the effects of a rehabilitation program with a powered lower extremity exoskeleton in people with stroke. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 5,370 interventional studies indexed under Stroke.
Browse Stroke studies →Corporación de Rehabilitación Club de Leones Cruz del Sur is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain). Patients will perform lower limb exercises assisted by the device. Training involve 24 sessions, 2 sessions per week for 12 weeks, each lasting about 1 hour.
Device: Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain)
Participants in this group will perform conventional gait rehabilitation on a rehabilitation institution with assistance of a physical therapist. Training involve 24 sessions, 2 sessions per week, each session lasting about 1 hour.
Behavioral: Conventional gait rehabilitation
The H3 is a powered lower extremity exoskeleton with actuated at hips, knees and ankles joints. A novel control software has been design and implemented in this device, which allows selective joint movement and recording of data from each rehabilitation session.
Conventional gait rehabilitation consist in walking and other applicable lower limb exercises performed by participants with assistance of a physical therapist.
Gait Deviation Index Baseline
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Time frame: Baseline
Gait Deviation Index Post-Intervention
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Time frame: 12 weeks
Maximal muscle strength Baseline
Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral hip extension-flexion, and hip adduction-abduction (standing), knee extension-flexion (seated), respectively. Both the affected (AF) and non-affected (NA) leg. A hand-held dynamometer will be used for the assessment.
Time frame: Baseline
Maximal muscle strength Post-Intervention
Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral hip extension-flexion, and hip adduction-abduction (standing), knee extension-flexion (seated), respectively. Both the affected (AF) and non-affected (NA) leg. A hand-held dynamometer will be used for the assessment.
Time frame: 12 weeks
Distance in 6 Minute Walk Test (6MWT) Baseline
Measure of the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test consist in a evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance.
Time frame: Baseline
Distance in 6 Minute Walk Test (6MWT) Post-Intervention
Measure of the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test consist in a evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance.
Time frame: 12 weeks
Muscle tone measured using modified ashworth scale (MAS) Baseline
Tests resistance to passive movement about a joint with varying degrees of velocity. A score of 1 indicates no resistance, and 5 indicates rigidity.
Time frame: Baseline
Muscle tone measured using modified ashworth scale (MAS) Post-Intervention
Tests resistance to passive movement about a joint with varying degrees of velocity. A score of 1 indicates no resistance, and 5 indicates rigidity.
Time frame: 12 weeks
Passive range of motion Baseline
Passive range of motion in lower extremities. ROM will be assessed by using an universal goniometer
Time frame: Baseline
Passive range of motion Post-Intervention
Passive range of motion in lower extremities. ROM will be assessed by using an universal goniometer
Time frame: 12 weeks
10 meter walk test Baseline
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Time frame: Baseline
10 meter walk test Post-Intervention
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Time frame: 12 weeks
Timed Up and Go Baseline
Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The person wears regular footwear and customary walking aid.
Time frame: Baseline
Timed Up and Go Post-Intervention
Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The person wears regular footwear and customary walking aid.
Time frame: 12 weeks
Berg Balance Scale Baseline
Berg balance scale is used for functional balance. participants are asked to perform 14 tasks frequently used in daily life activities. The highest possible score is 56 points. A higher score indicates better balance.
Time frame: Baseline
Berg Balance Scale Post-Intervention
Berg balance scale is used for functional balance. participants are asked to perform 14 tasks frequently used in daily life activities. The highest possible score is 56 points. A higher score indicates better balance.
Time frame: 12 weeks
Functional Ambulation Classification (FAC) Baseline
FAC is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.
Time frame: Baseline
Functional Ambulation Classification (FAC) Post-Intervention
FAC is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.
Time frame: 12 weeks
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
Measured with QUEST scale. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. Scores of 1 indicate dissatisfaction and scores of 5 indicate high satisfaction
Time frame: 12 weeks
Medical Research Council test (MRC) Baseline
Manual evaluation of muscle strength. This scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = no movement is observed, grade 5= muscle contracts normally against full resistance. Six muscles groups are tested at both sides of the body: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, ankle dorsiflexion. Maximal total score is 60.
Time frame: Baseline
Medical Research Council test (MRC) Post-Intervention
Manual evaluation of muscle strength. This scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = no movement is observed, grade 5= muscle contracts normally against full resistance. Six muscles groups are tested at both sides of the body: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, ankle dorsiflexion. Maximal total score is 60.
Time frame: 12 weeks
Gait Speed Baseline
Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Time frame: Baseline
Gait Speed Post-intervention
Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Time frame: 12 weeks
Plan to share: No
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Corporación de Rehabilitación Club de Leones Cruz del Sur