RehabilitationBCI-PTNCT04612426
the Effectiveness of Brain-computer Interface-pedaling Training System on the Rehabilitation of Stroke
A study testing Brain-computer Interface-Pedaling Training System and Traditional Pedaling Training System in people with Rehabilitation and Stroke, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Rehabilitation, Stroke, Brain-computer Interface
- What is being tested?
- Brain-computer Interface-Pedaling Training System and Traditional Pedaling Training System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severely impaired cognition, unable to pay attention to and understand screen information;
- Severe pain and limited mobility of lower extremity.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
About this study
Official title: 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.
- Conditions
- Rehabilitation, Stroke, Brain-computer Interface
- Being tested
- Brain-computer Interface-Pedaling Training System, Traditional Pedaling Training System
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-computer Interface-Pedaling Training SystemDevice
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 SystemDevice
The patient will wear the same EEG equipment that will only collect data, but not guide training.
| Study group | Role | What they receive |
|---|---|---|
| Brain-computer Interface-Pedaling Training System | Experimental | Not described Receives: 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. Receives: Device: Traditional Pedaling Training System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks after enrollment.
Secondary outcomes (3)
Attention index
We used EEG equipment to calculate attention index which ranges 0-100 points. The higher the score, the higher the participation.
Measured: Two weeks after enrollment.
Digital Span Test (DST)
The more correct numbers you recite, the greater your attention span.
Measured: Two weeks after enrollment.
Symbol Digit Modalities Test (SDMT)
The more numbers converted, the better the ability to shift and maintain attention.
Measured: Two weeks after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Nov 2020
- Primary completion10 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612426
- Sponsor's protocol ID
- XJUFH-R-001
- Acronym
- BCI-PT
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34871175
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effectiveness of Brain-computer Interface-pedaling Training System on Motor and Cognitive Function Rehabilitation of Stroke Patients
- ClinicalTrials.gov ID
- NCT04612426
- Acronym / sponsor ID
- BCI-PT / XJUFH-R-001
- Conditions
- Rehabilitation, Stroke, Brain-computer Interface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain-computer Interface-Pedaling Training System | Experimental | Device: Brain-computer Interface-Pedaling Training System |
| Traditional Pedaling Training System | Sham comparator | Device: Traditional Pedaling Training SystemPatients wear the same EEG equipment that only collect data, but not guide training. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Severely impaired cognition, unable to pay attention to and understand screen information;
- Severe pain and limited mobility of lower extremity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain-computer Interface-Pedaling Training SystemThe 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. | Device | Brain-computer Interface-Pedaling Training System |
| Traditional Pedaling Training SystemThe patient will wear the same EEG equipment that will only collect data, but not guide training. | Device | Traditional Pedaling Training System |
Primary outcome
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.
3 secondary outcomes
Attention index
Time frame: Two weeks after enrollment.
Digital Span Test (DST)
Time frame: Two weeks after enrollment.
Symbol Digit Modalities Test (SDMT)
Time frame: Two weeks after enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 34871175Yuan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-computer Interface-Pedaling Training System and Traditional Pedaling Training System in people with Rehabilitation and Stroke, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Fugl-Meyer motor function score of lower limbs (time frame: Two weeks after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04612426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.