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

NCT ID: NCT04995367

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2021-05-15

Brief Summary

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

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

The participants will carry out 4 tasks with a BCI system integrated to the T-FLEX device. The task consists of 1 session that includes 4 conditional experiments: Active ankle movement, passive ankle movement, Motor Imagery Detection with Visual cue, and Motor Imagery Detection with Tactile Stimulation and visual cue.

Interventions

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

The participants will carry out 4 tasks with a BCI system integrated to the T-FLEX device. The task consists of 1 session that includes 4 conditional experiments: Active ankle movement, passive ankle movement, Motor Imagery Detection with Visual cue, and Motor Imagery Detection with Tactile Stimulation and visual cue.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colombian School of Engineering Julio Garavito

OTHER

Sponsor Role: collaborator

Corporación de Rehabilitación Club de Leones Cruz del Sur

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asterio H Andrade, PhD

Role: STUDY_CHAIR

Rehabilitation Center Club de Leones Cruz del Sur

Locations

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, Chile

Countries

Chile

References

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Other Identifiers

CorporacionRCLCS0005

Identifier Type: -

Identifier Source: org_study_id