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Completed

NCT Number: NCT04995367

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

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

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, 6211525, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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

  2. 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).

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Corporación de Rehabilitación Club de Leones Cruz del Sur

Other

Collaborators

  • Colombian School of Engineering Julio Garavito

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2021
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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