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

NCT04612426 | Completed

• 1 other identifier: XJUFH-R-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Attention index

  Two weeks after enrollment.

• Digital Span Test (DST)

  Two weeks after enrollment.

• Symbol Digit Modalities Test (SDMT)

  Two weeks after enrollment.

Study Arms (2)

Brain-computer Interface-Pedaling Training System

EXPERIMENTAL

Device: Brain-computer Interface-Pedaling Training System

Traditional Pedaling Training System

SHAM COMPARATOR

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

Device: Traditional Pedaling Training System

Interventions

Brain-computer Interface-Pedaling Training System 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.

Brain-computer Interface-Pedaling Training System

Traditional Pedaling Training System DEVICE

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

Traditional Pedaling Training System

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

Related Publications (1)

• 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.

  PMID: 34871175 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: November 1, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 28, 2021
• Last Updated: April 15, 2021

Record last verified: 2020-10

Locations

CN (1)