Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile

Corporación de Rehabilitación Club de Leones Cruz del Sur

Status: Completed

Conditions: Stroke

Treatments: Device: Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain); Behavioral: Conventional gait rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04228224

CorporacionRCLCS0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Robot-assisted Rehabilitation

Experimental group

Description:

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.

Treatment:

Device: Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain)

Conventional Gait Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Conventional gait rehabilitation