Hemiplegia Following Ischemic StrokeREBUILTNCT04387474
The Effectiveness of Rehabilitation Training Based on Brain-computer Interface Technology to Improve the Upper Limb Motor Function of Ischemic Stroke.
A study testing Brain-computer interface and Traditional rehabilitation in people with Hemiplegia Following Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To evaluate the effectiveness and safety of rehabilitation training based on brain-computer interface in improving the upper motor function, self-care ability in daily life and quality of life in patients with ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiplegia Following Ischemic Stroke
- What is being tested?
- Brain-computer interface and Traditional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2020to 31 May 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (18 years<male or female≤80 years )
- Ischemic stroke diagnosed by MRI within 1 month before randomization
- Unilateral upper limb dysfunction with NIHSS score 1-3 at the time of randomization
- Informed consent signed
Who cannot join
- Unable to understand or cooperate because of severe aphasia or cognitive impairment (CDR >0.5) or mental illness
- A history of epilepsy
- Sensory disorders or hallucinations
- Internal carotid artery dissection or thrombolysis
- Apraxia
- Agnosia
Show all 12Show fewer
- Other diseases that may interfere with motor function
- Severe cardiopulmonary disease, severe illness, and unstable vital signs
- Severe balance dysfunction
- Participating in other clinical trial
- During pregnancy and lactation
- The Numerical Rating Scale (NRS) scores of upper extremities>4.
Trial locations and contacts
1 site in 1 country.
China1 site
China National Clinical Research Center for Neurological Diseases
Beijing, Beijing Municipality, 100070
About this study
Official title: China National Clinical Research Center for Neurological Diseases
To evaluate the effectiveness and safety of rehabilitation training based on brain-computer interface in improving the upper motor function, self-care ability in daily life and quality of life in patients with ischemic stroke. This study adopts centralized uniform random 1:1 grouping, subjects will be randomly assigned to the experimental group and the control group. Randomization schemes are generated by statistical professionals using SAS software.
Read the detailed description
Brain computer interface(BCI) is a noninvasive nervous system intervention. As a new method, it is applied in rehabilitation by stimulating peripheral nerve, such as motor, vibration, sensory, in combination with other stimulations, such as transcranial magnetic stimulation, transcranial electrical stimulation, etc.
In traditional rehabilitation therapy, hand-holding training is completed by physical therapist. Rehabilitation robot is also used for auxiliary training. BCI therapy will stimulate patients to take part in rehabilitation training more actively and obtain better effects on the rehabilitation of stroke.
- Conditions
- Hemiplegia Following Ischemic Stroke
- Being tested
- Brain-computer interface, Traditional rehabilitation
- Keywords
- Brain-computer interface, Electric stimulation therapy, Stroke rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-computer interfaceDevice
brain-computer interface rehabilitation training.
Traditional rehabilitationOther
traditional rehabilitation training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | brain-computer interface rehabilitation training and traditional rehabilitation training. Receives: Device: Brain-computer interface; Other: Traditional rehabilitation |
| Control group | Other | traditional rehabilitation training. Receives: Other: Traditional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of upper limb motor function at 1 month after randomization.
Tested by Fugl-Meyer Assessment (FMA) scale.
Measured: 1 month after randomization compared with traditional rehabilitation strategy.
Secondary outcomes (4)
The improvement of upper limb motor function at 3 month after randomization.
Tested by Fugl-Meyer Assessment (FMA) scale.
Measured: 3 months after randomization compared with traditional rehabilitation strategy .
The improvement of upper limb motor function at 1, 3 month after randomization.
Tested by Action Research Arm Test (ARAT), The Wolf Motor Function Test (WMFT).
Measured: 1, 3 months after randomization compared with traditional rehabilitation strategy.
The improvement in muscle tone at 1, 3 month after randomization.
Tested by the Modified Ashworth scale (MAS).
Measured: 1, 3 months after randomization compared with traditional rehabilitation strategy.
The improvement of patients' ability to take care of themselves in daily life
Tested by Instrumental Activity of Daily living (IDAL).
Measured: 1, 3 months after randomization compared with traditional rehabilitation strategy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start10 May 2020
- Primary completion20 Apr 2022
- Study completion31 May 2022
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 Hemiplegia Following Ischemic StrokeStudies 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
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387474
- Sponsor's protocol ID
- KY2019-089-02
- Acronym
- REBUILT
- Status last verified
- Feb 2024
- First submitted
- 9 May 2020
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data described in the outcomes section are available on request to the corresponding author. The protocol and SAP was uploaded in the supplemental materials with the paper
Publications
Wang A, Tian X, Jiang D, Yang C, Xu Q, Zhang Y, Zhao S, Zhang X, Jing J, Wei N, Wu Y, Lv W, Yang B, Zang D, Wang Y, Zhang Y, Wang Y, Meng X. Rehabilitation with brain-computer interface and upper limb motor function in ischemic stroke: A randomized controlled trial. Med. 2024 Jun 14;5(6):559-569.e4. doi: 10.1016/j.medj.2024.02.014. Epub 2024 Apr 19.
PubMed 38642555
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China National Clinical Research Center for Neurological Diseases
- ClinicalTrials.gov ID
- NCT04387474
- Acronym / sponsor ID
- REBUILT / KY2019-089-02
- Conditions
- Hemiplegia Following Ischemic Stroke
- Keywords
- Brain-computer interface, Electric stimulation therapy, Stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 13 May 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.
To evaluate the effectiveness and safety of rehabilitation training based on brain-computer interface in improving the upper motor function, self-care ability in daily life and quality of life in patients with ischemic stroke. This study adopts centralized uniform random 1:1 grouping, subjects will be randomly assigned to the experimental group and the control group. Randomization schemes are generated by statistical professionals using SAS software.
Detailed description
Brain computer interface(BCI) is a noninvasive nervous system intervention. As a new method, it is applied in rehabilitation by stimulating peripheral nerve, such as motor, vibration, sensory, in combination with other stimulations, such as transcranial magnetic stimulation, transcranial electrical stimulation, etc.
In traditional rehabilitation therapy, hand-holding training is completed by physical therapist. Rehabilitation robot is also used for auxiliary training. BCI therapy will stimulate patients to take part in rehabilitation training more actively and obtain better effects on the rehabilitation of stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Brain-computer interface, Other: Traditional rehabilitationbrain-computer interface rehabilitation training and traditional rehabilitation training. |
| Control group | Other | Other: Traditional rehabilitationtraditional rehabilitation training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult subjects (18 years<male or female≤80 years )
- Ischemic stroke diagnosed by MRI within 1 month before randomization
- Unilateral upper limb dysfunction with NIHSS score 1-3 at the time of randomization
- Informed consent signed
Key exclusion criteria (12 listed)
- Unable to understand or cooperate because of severe aphasia or cognitive impairment (CDR >0.5) or mental illness
- A history of epilepsy
- Sensory disorders or hallucinations
- Internal carotid artery dissection or thrombolysis
- Apraxia
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 interfacebrain-computer interface rehabilitation training. | Device | Experimental group |
| Traditional rehabilitationtraditional rehabilitation training. | Other | Control group, Experimental group |
Primary outcome
The improvement of upper limb motor function at 1 month after randomization.
Time frame: 1 month after randomization compared with traditional rehabilitation strategy.
Tested by Fugl-Meyer Assessment (FMA) scale.
4 secondary outcomes
The improvement of upper limb motor function at 3 month after randomization.
Time frame: 3 months after randomization compared with traditional rehabilitation strategy .
The improvement of upper limb motor function at 1, 3 month after randomization.
Time frame: 1, 3 months after randomization compared with traditional rehabilitation strategy.
The improvement in muscle tone at 1, 3 month after randomization.
Time frame: 1, 3 months after randomization compared with traditional rehabilitation strategy.
The improvement of patients' ability to take care of themselves in daily life
Time frame: 1, 3 months after randomization compared with traditional rehabilitation strategy.
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 21 Feb 2024.
- Derived from this study: PubMed 38642555Wang A, Tian X, Jiang D, Yang C, Xu Q, Zhang Y, Zhao S, Zhang X, Jing J, Wei N, Wu Y, Lv W, Yang B, Zang D, Wang Y, Zhang Y, Wang Y, Meng X. Rehabilitation with brain-computer interface and upper limb motor function in ischemic stroke: A randomized controlled trial. Med. 2024 Jun 14;5(6):559-569.e4. doi: 10.1016/j.medj.2024.02.014. Epub 2024 Apr 19.
- Individual participant dataSharing planned: No. All data described in the outcomes section are available on request to the corresponding author. The protocol and SAP was uploaded in the supplemental materials with the paper
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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 and Traditional rehabilitation in people with Hemiplegia Following Ischemic Stroke, run by Beijing Tiantan Hospital 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 4 inclusion and 12 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 21 Feb 2024. 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. 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 improvement of upper limb motor function at 1 month after randomization. (time frame: 1 month after randomization compared with traditional rehabilitation strategy.). 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 NCT04387474, 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 21 Feb 2024.