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Completed

NCT Number: NCT04612426

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

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.

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Key information

Conditions

Rehabilitation Brain Diseases Brain-Computer Interface Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Traditional Pedaling Training System

Device

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

Primary outcomes

  1. The change of Fugl-Meyer motor function score of lower limbs

    Time frame: Two weeks after enrollment.

    The score range is 0-34 points, the higher the score, the better the motor function of lower limb.

Secondary outcomes

  1. Attention index

    Time frame: 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.

  2. Digital Span Test (DST)

    Time frame: Two weeks after enrollment.

    The more correct numbers you recite, the greater your attention span.

  3. Symbol Digit Modalities Test (SDMT)

    Time frame: Two weeks after enrollment.

    The more numbers converted, the better the ability to shift and maintain attention.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: BCI-PT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 3, 2020
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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