the Effectiveness of Brain-computer Interface-pedaling Training System on the Rehabilitation of Stroke (BCI-PT)

Xi'an Jiaotong University

Status: Completed

Conditions: Rehabilitation; Brain-computer Interface; Stroke

Treatments: Device: Brain-computer Interface-Pedaling Training System; Device: Traditional Pedaling Training System

Study type: Interventional

Funder types: Other

Identifiers

NCT04612426

XJUFH-R-001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Brain-computer Interface-Pedaling Training System

Experimental group

Treatment:

Device: Brain-computer Interface-Pedaling Training System

Traditional Pedaling Training System

Sham Comparator group

Description:

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

Treatment:

Device: Traditional Pedaling Training System