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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Rehabilitation; Brain-computer Interface
• Intervention / Treatment: Device: Brain-computer Interface-Pedaling Training System; Device: Traditional Pedaling Training System

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • First Affiliated Hospital of Xi'an JiaoTong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brain-computer Interface-Pedaling Training System	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.
Sham Comparator: Traditional Pedaling Training System; Patients wear the same EEG equipment that only collect data, but not guide training.	Device: Traditional Pedaling Training System; The patient will wear the same EEG equipment that will only collect data, but not guide training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Digital Span Test (DST)	The more correct numbers you recite, the greater your attention span.	Two weeks after enrollment.
Symbol Digit Modalities Test (SDMT)	The more numbers converted, the better the ability to shift and maintain attention.	Two weeks after enrollment.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: XJUFH-R-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No