NCT04995367

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

June 7, 2021

Last Update Submit

August 4, 2021

Conditions

Stroke

Keywords

StrokeBrain-Computer InterfaceExoskeleton

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline

  • 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).

    Baseline

Secondary Outcomes (1)

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

    Baseline

Study Arms (1)

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

EXPERIMENTAL

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.

Interventions

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.

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, 6211525, Chile

Location

Related Publications (9)

  • 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.

    PMID: 22196422BACKGROUND

  • 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.

    PMID: 20046132BACKGROUND

  • 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.

    PMID: 24941413BACKGROUND

  • 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.

    PMID: 33805216BACKGROUND

  • 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.

    PMID: 29345632BACKGROUND

  • 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.

    PMID: 32973481BACKGROUND

  • 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.

    PMID: 28145274BACKGROUND

  • 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.

    PMID: 23639955BACKGROUND

  • 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.

    PMID: 33014987BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Asterio H Andrade, PhD

    Rehabilitation Center Club de Leones Cruz del Sur

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2021

First Posted

August 6, 2021

Study Start

March 15, 2021

Primary Completion

May 12, 2021

Study Completion

May 15, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)