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

NCT ID: NCT04612426

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-02-28

Brief 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.

Conditions

Rehabilitation; Stroke; Brain-computer Interface

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brain-computer Interface-Pedaling Training System

Group Type: EXPERIMENTAL

Brain-computer Interface-Pedaling Training System

Intervention Type: DEVICE

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

Patients wear the same EEG equipment that only collect data, but not guide training.

Group Type: SHAM_COMPARATOR

Traditional Pedaling Training System

Intervention Type: DEVICE

The patient will wear the same EEG equipment that will only collect data, but not guide training.

Interventions

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.

Intervention Type: DEVICE

Traditional Pedaling Training System

The patient will wear the same EEG equipment that will only collect data, but not guide training.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

References

Yuan Z, Peng Y, Wang L, Song S, Chen S, Yang L, Liu H, Wang H, Shi G, Han C, Cammon JA, Zhang Y, Qiao J, Wang G. Effect of BCI-Controlled Pedaling Training System With Multiple Modalities of Feedback on Motor and Cognitive Function Rehabilitation of Early Subacute Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2021;29:2569-2577. doi: 10.1109/TNSRE.2021.3132944. Epub 2021 Dec 21.

Reference Type: DERIVED

PMID: 34871175 (View on PubMed)

Other Identifiers

XJUFH-R-001

Identifier Type: -

Identifier Source: org_study_id