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

Primary Purpose

Hemiplegia Following Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Brain-computer interface
Traditional rehabilitation
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia Following Ischemic Stroke focused on measuring Brain-computer interface, Electric stimulation therapy, Stroke rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China National Clinical Research Center for Neurological Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

brain-computer interface rehabilitation training and traditional rehabilitation training.

traditional rehabilitation training.

Outcomes

Primary Outcome Measures

The improvement of upper limb motor function at 1 month after randomization.
Tested by Fugl-Meyer Assessment (FMA) scale.

Secondary Outcome Measures

The improvement of upper limb motor function at 3 month after randomization.
Tested by Fugl-Meyer Assessment (FMA) scale.
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).
The improvement in muscle tone at 1, 3 month after randomization.
Tested by the Modified Ashworth scale (MAS).
The improvement of patients' ability to take care of themselves in daily life
Tested by Instrumental Activity of Daily living (IDAL).

Full Information

First Posted
May 9, 2020
Last Updated
July 3, 2022
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04387474
Brief Title
The Effectiveness of Rehabilitation Training Based on Brain-computer Interface Technology to Improve the Upper Limb Motor Function of Ischemic Stroke.
Acronym
REBUILT
Official Title
China National Clinical Research Center for Neurological Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2020 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia Following Ischemic Stroke
Keywords
Brain-computer interface, Electric stimulation therapy, Stroke rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
brain-computer interface rehabilitation training and traditional rehabilitation training.
Arm Title
Control group
Arm Type
Other
Arm Description
traditional rehabilitation training.
Intervention Type
Device
Intervention Name(s)
Brain-computer interface
Intervention Description
brain-computer interface rehabilitation training.
Intervention Type
Other
Intervention Name(s)
Traditional rehabilitation
Intervention Description
traditional rehabilitation training.
Primary Outcome Measure Information:
Title
The improvement of upper limb motor function at 1 month after randomization.
Description
Tested by Fugl-Meyer Assessment (FMA) scale.
Time Frame
1 month after randomization compared with traditional rehabilitation strategy.
Secondary Outcome Measure Information:
Title
The improvement of upper limb motor function at 3 month after randomization.
Description
Tested by Fugl-Meyer Assessment (FMA) scale.
Time Frame
3 months after randomization compared with traditional rehabilitation strategy .
Title
The improvement of upper limb motor function at 1, 3 month after randomization.
Description
Tested by Action Research Arm Test (ARAT), The Wolf Motor Function Test (WMFT).
Time Frame
1, 3 months after randomization compared with traditional rehabilitation strategy.
Title
The improvement in muscle tone at 1, 3 month after randomization.
Description
Tested by the Modified Ashworth scale (MAS).
Time Frame
1, 3 months after randomization compared with traditional rehabilitation strategy.
Title
The improvement of patients' ability to take care of themselves in daily life
Description
Tested by Instrumental Activity of Daily living (IDAL).
Time Frame
1, 3 months after randomization compared with traditional rehabilitation strategy.
Other Pre-specified Outcome Measures:
Title
The changes of brain network properties.
Description
Evaluated by fMRI before and after rehabilitaion.
Time Frame
1 month and 3 months after randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Facility Information:
Facility Name
China National Clinical Research Center for Neurological Diseases
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China

12. IPD Sharing Statement

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

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