the Effectiveness of Brain-computer Interface-pedaling Training System on the Rehabilitation of Stroke

Stroke Clinical Trial

— BCI-PT  

Official title:

the Effectiveness of Brain-computer Interface-pedaling Training System on Motor and Cognitive Function Rehabilitation of Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612426
• Other study ID #: XJUFH-R-001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: October 2020
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stroke has become the first cause of death and disability among Chinese adults. 70%-80% of patients cannot live independently due to disability, which has brought a heavy burden to families, medical institutions and society. How to better evaluate and improve post-stroke motor and cognitive dysfunction has always been a hot research topic. With the rapid development of brain-computer interface technology, rehabilitation assessment based on quantitative EEG analysis is gradually being applied in the medical field. So we designed a brain-computer interface based on hierarchical task induction-pedaling rehabilitation training system to investigate the effectiveness on the rehabilitation of stroke patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged 40-80 years old;
• Patients with first ischemic stroke onset from 1 week to 3 months;
• Hemiplegia and cognitive impairment (Mini-Mental State Examination (MMSE) score <28 or Montreal Cognitive Assessment (MoCA) <25);
• Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
• The patient or its authorized agent signs the informed consent form.

Exclusion Criteria:

• Severely impaired cognition, unable to pay attention to and understand screen information;
• Severe pain and limited mobility of lower extremity.

Related Conditions & MeSH terms

• Brain-computer Interface
• Rehabilitation
• Stroke

Intervention

Device:
• Brain-computer Interface-Pedaling Training System
The Brain-computer Interface-Pedaling Training System includes four parts: computer, monitor, EEG testing equipment and pedaling training equipment. The patient wears an EEG detection device, which calculates brain movement participation every 0.5 seconds. The system will provide real-time visual/auditory/somatosensory feedback to patients based on the results of participation, so that patients can participate in motor function training more attentively.
• Traditional Pedaling Training System
The patient will wear the same EEG equipment that will only collect data, but not guide training.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of Fugl-Meyer motor function score of lower limbs	The score range is 0-34 points, the higher the score, the better the motor function of lower limb.	Two weeks after enrollment.
Secondary	Attention index	We used EEG equipment to calculate attention index which ranges 0-100 points. The higher the score, the higher the participation.	Two weeks after enrollment.
Secondary	Digital Span Test (DST)	The more correct numbers you recite, the greater your attention span.	Two weeks after enrollment.
Secondary	Symbol Digit Modalities Test (SDMT)	The more numbers converted, the better the ability to shift and maintain attention.	Two weeks after enrollment.