Back to resultsthe Effectiveness of Brain-computer Interface-pedaling Training System on the Rehabilitation of Stroke (BCI-PT)
Primary Purpose
Rehabilitation, Stroke, Brain-computer Interface
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Brain-computer Interface-Pedaling Training System
Traditional Pedaling Training System
Sponsored by
About this trial
This is an interventional treatment trial for Rehabilitation
Eligibility Criteria
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.
Sites / Locations
- First Affiliated Hospital of Xi'an Jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Brain-computer Interface-Pedaling Training System
Traditional Pedaling Training System
Arm Description
Patients wear the same EEG equipment that only collect data, but not guide training.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Attention index
We used EEG equipment to calculate attention index which ranges 0-100 points. The higher the score, the higher the participation.
Digital Span Test (DST)
The more correct numbers you recite, the greater your attention span.
Symbol Digit Modalities Test (SDMT)
The more numbers converted, the better the ability to shift and maintain attention.
Full Information
NCT ID
NCT04612426
First Posted
October 28, 2020
Last Updated
April 13, 2021
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT04612426
Brief Title
the Effectiveness of Brain-computer Interface-pedaling Training System on the Rehabilitation of Stroke
Acronym
BCI-PT
Official Title
the Effectiveness of Brain-computer Interface-pedaling Training System on Motor and Cognitive Function Rehabilitation of Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation, Stroke, Brain-computer Interface
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brain-computer Interface-Pedaling Training System
Arm Type
Experimental
Arm Title
Traditional Pedaling Training System
Arm Type
Sham Comparator
Arm Description
Patients wear the same EEG equipment that only collect data, but not guide training.
Intervention Type
Device
Intervention Name(s)
Brain-computer Interface-Pedaling Training System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional Pedaling Training System
Intervention Description
The patient will wear the same EEG equipment that will only collect data, but not guide training.
Primary Outcome Measure Information:
Title
The change of Fugl-Meyer motor function score of lower limbs
Description
The score range is 0-34 points, the higher the score, the better the motor function of lower limb.
Time Frame
Two weeks after enrollment.
Secondary Outcome Measure Information:
Title
Attention index
Description
We used EEG equipment to calculate attention index which ranges 0-100 points. The higher the score, the higher the participation.
Time Frame
Two weeks after enrollment.
Title
Digital Span Test (DST)
Description
The more correct numbers you recite, the greater your attention span.
Time Frame
Two weeks after enrollment.
Title
Symbol Digit Modalities Test (SDMT)
Description
The more numbers converted, the better the ability to shift and maintain attention.
Time Frame
Two weeks after enrollment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34871175
Citation
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.
Results Reference
derived
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the Effectiveness of Brain-computer Interface-pedaling Training System on the Rehabilitation of Stroke
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