Clinical trial NCT04995367: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Brain-Computer Interface
Exoskeleton
Lead sponsor: Corporación de Rehabilitación Club de Leones Cruz del Sur
Sponsor class: OTHER
Collaborators: name: Colombian School of Engineering Julio Garavito
First posted: 2021-08-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Response time
timeFrame: Baseline
measure: EEG signals from primary motor cortex
timeFrame: Baseline
Secondary outcomes:
measure: Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
timeFrame: Baseline
Other outcomes:
Locations:
city: Punta Arenas
country: Chile
facility: Corporación de Rehabilitación Club de Leones Cruz del Sur
state: XII Región
Study officials:
affiliation: Rehabilitation Center Club de Leones Cruz del Sur
name: Asterio H Andrade, PhD
role: STUDY_CHAIR
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