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

Not Applicable

Completed

• Conditions: Rehabilitation; Brain-computer Interface; Stroke
• Interventions: Device: Brain-computer Interface-Pedaling Training System; Device: Traditional Pedaling Training System

• Registration Number: NCT04612426
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-28
• Study Start: 2020-11-01
• Study First Submitted QC: 2020-11-01
• Study First Posted: 2020-11-03
• Primary Completion: 2021-02-10
• Study Completion: 2021-02-28
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brain-computer Interface-Pedaling Training System	Brain-computer Interface-Pedaling Training System	-
Traditional Pedaling Training System	Traditional Pedaling Training System	Patients wear the same EEG equipment that only collect data, but not guide training.

Primary Outcome Measures

Name	Time	Method
The change of Fugl-Meyer motor function score of lower limbs	Two weeks after enrollment.	The score range is 0-34 points, the higher the score, the better the motor function of lower limb.

Secondary Outcome Measures

Name	Time	Method
Attention index	Two weeks after enrollment.	We used EEG equipment to calculate attention index which ranges 0-100 points. The higher the score, the higher the participation.
Symbol Digit Modalities Test (SDMT)	Two weeks after enrollment.	The more numbers converted, the better the ability to shift and maintain attention.
Digital Span Test (DST)	Two weeks after enrollment.	The more correct numbers you recite, the greater your attention span.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China