BCI-Based Control for Ankle Exoskeleton T-FLEX: Comparison of Visual and Haptic Feedback With Stroke Survivors

Corporación de Rehabilitación Club de Leones Cruz del Sur

Status: Completed

Conditions: Stroke

Treatments: Device: Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients.

Study type: Interventional

Funder types: Other

Identifiers

NCT04995367

CorporacionRCLCS0005

Details and patient eligibility

About

This protocol will developed an assessment of the T-FLEX device controlled by Brain-Computer Interface in patients with Stroke.

Full description

Brain-Computer Interface (BCI) remains an emerging tool that seeks to improve the patient interaction with the therapeutic mechanisms and to generate neuroplasticity progressively through neuromotor abilities. Motor Imagery (MI) analysis is the most used paradigm based on the motor cortex's electrical activity to detect movement intention. It has been shown that motor imagery mental practice with movement-associated feedback may offer an effective strategy to facilitate motor recovery in brain injury patients. This protocol will study a BCI system associated with visual and haptic feedback to facilitate MI generation and, to control a T-FLEX ankle exoskeleton. In this study, a group of five post-stroke patients will test four different strategies using T-FLEX: Passive movement, Active movement, Motor Imagination with Visual stimulation and Motor Imagination with Visual-Haptic stimuli. The quantitative characterization of BCI performance will be made by using statistical analysis of electroencephalographic data. Finally, the patient's satisfaction will be evaluated by a questionnaire.

Enrollment: 5 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral lower extremity paresis
• Hemorrhagic 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke

Experimental group

Description:

The participants will carry out tests for the evaluation of the functionality of the BCI system integrated to the T-FLEX device. The test consists of 1 session that includes four conditional experiments. Real Movement, Continuous Stationary Therapy, Motor Imagery Detection with Visual Stimulation, and Motor Imagery Detection with Tactile Stimulation.

Treatment:

Device: Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients.