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

August 4, 2021 updated by: Corporación de Rehabilitación Club de Leones Cruz del Sur
This protocol will developed an assessment of the T-FLEX device controlled by Brain-Computer Interface in patients with Stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • XII Región
      • Punta Arenas, XII Región, Chile, 6211525
        • Corporación de Rehabilitación Club de Leones Cruz del Sur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response time
Time Frame: 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
Baseline
EEG signals from primary motor cortex
Time Frame: 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).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
Time Frame: 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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporación de Rehabilitación Club de Leones Cruz del Sur

Collaborators

Colombian School of Engineering Julio Garavito

Investigators

  • Study Chair: Asterio H Andrade, PhD, Rehabilitation Center Club de Leones Cruz del Sur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

May 12, 2021

Study Completion (Actual)

May 15, 2021

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CorporacionRCLCS0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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