The Effectiveness of Rehabilitation Training Based on Brain-computer Interface Technology to Improve the Upper Limb Motor Function of Ischemic Stroke. (REBUILT)

February 19, 2024 updated by: Beijing Tiantan Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • China National Clinical Research Center for Neurological Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult subjects (18 years<male or female≤80 years )
  2. Ischemic stroke diagnosed by MRI within 1 month before randomization
  3. Unilateral upper limb dysfunction with NIHSS score 1-3 at the time of randomization
  4. Informed consent signed

Exclusion Criteria:

  1. Unable to understand or cooperate because of severe aphasia or cognitive impairment (CDR >0.5) or mental illness
  2. A history of epilepsy
  3. Sensory disorders or hallucinations
  4. Internal carotid artery dissection or thrombolysis
  5. Apraxia
  6. Agnosia
  7. Other diseases that may interfere with motor function
  8. Severe cardiopulmonary disease, severe illness, and unstable vital signs
  9. Severe balance dysfunction
  10. Participating in other clinical trial
  11. During pregnancy and lactation
  12. The Numerical Rating Scale (NRS) scores of upper extremities>4.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
brain-computer interface rehabilitation training and traditional rehabilitation training.
Device: Brain-computer interface
brain-computer interface rehabilitation training.
Other: Traditional rehabilitation
traditional rehabilitation training.
Other: Control group
traditional rehabilitation training.
Other: Traditional rehabilitation
traditional rehabilitation training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month after randomization compared with traditional rehabilitation strategy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement of upper limb motor function at 3 month after randomization.
Time Frame: 3 months after randomization compared with traditional rehabilitation strategy .
Tested by Fugl-Meyer Assessment (FMA) scale.
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.
Tested by Action Research Arm Test (ARAT), The Wolf Motor Function Test (WMFT).
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.
Tested by the Modified Ashworth scale (MAS).
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.
Tested by Instrumental Activity of Daily living (IDAL).
1, 3 months after randomization compared with traditional rehabilitation strategy.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of brain network properties.
Time Frame: 1 month and 3 months after randomization.
Evaluated by fMRI before and after rehabilitaion.
1 month and 3 months after randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2020

Primary Completion (Actual)

April 20, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

May 9, 2020

First Submitted That Met QC Criteria

May 9, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2019-089-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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