BCI-Based Control for Ankle Exoskeleton T-FLEX: Comparison of Visual and Haptic Feedback With Stroke Survivors
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients.
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Brain-Computer Interface, Exoskeleton
Eligibility Criteria
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
Sites / Locations
- Corporación de Rehabilitación Club de Leones Cruz del Sur
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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).
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04995367
First Posted
June 7, 2021
Last Updated
August 4, 2021
Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
Collaborators
Colombian School of Engineering Julio Garavito
1. Study Identification
Unique Protocol Identification Number
NCT04995367
Brief Title
BCI-Based Control for Ankle Exoskeleton T-FLEX: Comparison of Visual and Haptic Feedback With Stroke Survivors
Official Title
BCI-Based Control for Ankle Exoskeleton T-FLEX: Comparison of Visual and Haptic Feedback With Stroke Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
May 12, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
Collaborators
Colombian School of Engineering Julio Garavito
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Brain-Computer Interface, Exoskeleton
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients.
Intervention Description
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 Outcome Measure Information:
Title
Response time
Description
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
Time Frame
Baseline
Title
EEG signals from primary motor cortex
Description
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).
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
Description
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
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asterio H Andrade, PhD
Organizational Affiliation
Rehabilitation Center Club de Leones Cruz del Sur
Official's Role
Study Chair
Facility Information:
Facility Name
Corporación de Rehabilitación Club de Leones Cruz del Sur
City
Punta Arenas
State/Province
XII Región
ZIP/Postal Code
6211525
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22196422
Citation
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Results Reference
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Citation
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PubMed Identifier
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Citation
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.
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PubMed Identifier
33805216
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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BCI-Based Control for Ankle Exoskeleton T-FLEX: Comparison of Visual and Haptic Feedback With Stroke Survivors
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