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

Not Applicable

Completed

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

• Registration Number: NCT04995367
• Lead Sponsor: Corporación de Rehabilitación Club de Leones Cruz del Sur

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.

Study Timeline

• Study Start: 2021-03-15
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-15
• Study First Submitted: 2021-06-07
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-04
• Last Update Submitted: 2021-08-04
• Study First Posted: 2021-08-06
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Response time	Baseline	The response time for each task will be automatically measured by a Visual Studio Code Software during the use of the Brain-Computer Interface.; This variable will consider the response time of a specific command, since the subject receives the stimulation until the software detects the EEG Signal. The measure unit is milliseconds
EEG signals from primary motor cortex	Baseline	continuous signals will be acquired from the primary motor cortex of lower limbs (FcZ, C2, Cz, C1, Cpz) according to the 10-20 International EEG System. Power spectral density in the frequency band of motor imagery (8-32Hz) will be obtained by OpenVibe Software and Matlab. The measure unit is Decibels per Hertz(dB/Hz).

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology	Baseline	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

Trial Locations

Locations (1)

Corporación de Rehabilitación Club de Leones Cruz del Sur; 🇨🇱 Punta Arenas, XII Región, Chile