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StrokeNCT04995367

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

A study testing Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients. in people with Stroke, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Stroke
What is being tested?
Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteChile
Study dates
15 Mar 2021to 15 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Chile1 site

  • Corporación de Rehabilitación Club de Leones Cruz del Sur

    Punta Arenas, Region of Magallanes, 6211525

Other trials in Chile

About this study

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

Read the 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
Being tested
Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients.
Keywords
Stroke, Brain-Computer Interface, Exoskeleton
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04995367
Study groupRoleWhat they receive
Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-strokeExperimentalThe 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.
Receives: Device: Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response time

    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

    Measured: Baseline

  2. EEG signals from primary motor cortex

    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).

    Measured: Baseline

Secondary outcomes (1)

  1. Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology

    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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study start15 Mar 2021
  3. Primary completion12 May 2021
  4. Study completion15 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04995367
Sponsor's protocol ID
CorporacionRCLCS0005
Status last verified
Aug 2021
First submitted
7 Jun 2021
Last updated
6 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Verma R, Arya KN, Sharma P, Garg RK. Understanding gait control in post-stroke: implications for management. J Bodyw Mov Ther. 2012 Jan;16(1):14-21. doi: 10.1016/j.jbmt.2010.12.005. Epub 2010 Dec 30.

    PubMed 22196422

  • Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29.

    PubMed 20046132

  • Chen G, Chan CK, Guo Z, Yu H. A review of lower extremity assistive robotic exoskeletons in rehabilitation therapy. Crit Rev Biomed Eng. 2013;41(4-5):343-63. doi: 10.1615/critrevbiomedeng.2014010453.

    PubMed 24941413

  • Gomez-Vargas D, Ballen-Moreno F, Barria P, Aguilar R, Azorin JM, Munera M, Cifuentes CA. The Actuation System of the Ankle Exoskeleton T-FLEX: First Use Experimental Validation in People with Stroke. Brain Sci. 2021 Mar 24;11(4):412. doi: 10.3390/brainsci11040412.

    PubMed 33805216

  • He Y, Eguren D, Azorin JM, Grossman RG, Luu TP, Contreras-Vidal JL. Brain-machine interfaces for controlling lower-limb powered robotic systems. J Neural Eng. 2018 Apr;15(2):021004. doi: 10.1088/1741-2552/aaa8c0.

    PubMed 29345632

  • Ortiz M, Ianez E, Contreras-Vidal JL, Azorin JM. Analysis of the EEG Rhythms Based on the Empirical Mode Decomposition During Motor Imagery When Using a Lower-Limb Exoskeleton. A Case Study. Front Neurorobot. 2020 Aug 27;14:48. doi: 10.3389/fnbot.2020.00048. eCollection 2020.

    PubMed 32973481

  • Ma T, Li H, Deng L, Yang H, Lv X, Li P, Li F, Zhang R, Liu T, Yao D, Xu P. The hybrid BCI system for movement control by combining motor imagery and moving onset visual evoked potential. J Neural Eng. 2017 Apr;14(2):026015. doi: 10.1088/1741-2552/aa5d5f. Epub 2017 Feb 1.

    PubMed 28145274

  • Thomas E, Dyson M, Clerc M. An analysis of performance evaluation for motor-imagery based BCI. J Neural Eng. 2013 Jun;10(3):031001. doi: 10.1088/1741-2560/10/3/031001. Epub 2013 May 3.

    PubMed 23639955

  • Ortiz M, Ferrero L, Ianez E, Azorin JM, Contreras-Vidal JL. Sensory Integration in Human Movement: A New Brain-Machine Interface Based on Gamma Band and Attention Level for Controlling a Lower-Limb Exoskeleton. Front Bioeng Biotechnol. 2020 Sep 3;8:735. doi: 10.3389/fbioe.2020.00735. eCollection 2020.

    PubMed 33014987

Questions about this trial

What is this clinical trial studying?

A study testing Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients. in people with Stroke, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response time (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04995367, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.

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Clinical Trial NCT04995367 | AzTrials