Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile
- Conditions
- Stroke
- Interventions
- Device: Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain)Behavioral: Conventional gait rehabilitation
- Registration Number
- NCT04228224
- Lead Sponsor
- Corporación de Rehabilitación Club de Leones Cruz del Sur
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- unilateral lower extremity paresis
- haemorrhagic or ischemic stroke
- a minimum of six months after the acute infarction/onset of the disease
- full passive range of motion in lower extremity or at least at neutral position
- be able to stand freely
- be able to walk with or without aid for at least 20 meters in less than 2 minutes
- peripheral nervous system pathology
- epilepsy
- weight over 100 kg
- no cognitive ability to follow the study instructions
- pregnancy
- use of implanted devices
- instable lower extremity joints or fixed contracture
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robot-assisted Rehabilitation Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain) 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. Conventional Gait Rehabilitation Conventional gait rehabilitation 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.
- Primary Outcome Measures
Name Time Method Gait Deviation Index Post-Intervention 12 weeks Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Gait Deviation Index Baseline Baseline Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
- Secondary Outcome Measures
Name Time Method Muscle tone measured using modified ashworth scale (MAS) Post-Intervention 12 weeks Tests resistance to passive movement about a joint with varying degrees of velocity. A score of 1 indicates no resistance, and 5 indicates rigidity.
Passive range of motion Post-Intervention 12 weeks Passive range of motion in lower extremities. ROM will be assessed by using an universal goniometer
Gait Speed Baseline Baseline Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Maximal muscle strength Baseline 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.
Distance in 6 Minute Walk Test (6MWT) Baseline 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.
Muscle tone measured using modified ashworth scale (MAS) Baseline 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.
Passive range of motion Baseline Baseline Passive range of motion in lower extremities. ROM will be assessed by using an universal goniometer
10 meter walk test Baseline 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.
10 meter walk test Post-Intervention 12 weeks 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.
Timed Up and Go Baseline 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.
Maximal muscle strength Post-Intervention 12 weeks 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.
Distance in 6 Minute Walk Test (6MWT) Post-Intervention 12 weeks 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.
Timed Up and Go Post-Intervention 12 weeks 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.
Gait Speed Post-intervention 12 weeks Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Berg Balance Scale Baseline 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.
Functional Ambulation Classification (FAC) Baseline 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.
Berg Balance Scale Post-Intervention 12 weeks 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.
Functional Ambulation Classification (FAC) Post-Intervention 12 weeks 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.
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology 12 weeks 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
Medical Research Council test (MRC) Baseline 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.
Medical Research Council test (MRC) Post-Intervention 12 weeks 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.
Trial Locations
- Locations (1)
Corporación de Rehabilitación Club de Leones Cruz del Sur
🇨🇱Punta Arenas, XII Región, Chile