Hemiplegia Following Ischemic Stroke
Conditions
Keywords
Brain-computer interface, Electric stimulation therapy, Stroke rehabilitation
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.
Interventions
DEVICEBrain-computer interface
brain-computer interface rehabilitation training.
traditional rehabilitation training.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The improvement of upper limb motor function at 1 month after randomization. | 1 month after randomization compared with traditional rehabilitation strategy. | Tested by Fugl-Meyer Assessment (FMA) scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The improvement of upper limb motor function at 3 month after randomization. | 3 months after randomization compared with traditional rehabilitation strategy . | Tested by Fugl-Meyer Assessment (FMA) scale. |
| The improvement of upper limb motor function at 1, 3 month after randomization. | 1, 3 months after randomization compared with traditional rehabilitation strategy. | Tested by Action Research Arm Test (ARAT), The Wolf Motor Function Test (WMFT). |
| The improvement in muscle tone at 1, 3 month after randomization. | 1, 3 months after randomization compared with traditional rehabilitation strategy. | Tested by the Modified Ashworth scale (MAS). |
| The improvement of patients' ability to take care of themselves in daily life | 1, 3 months after randomization compared with traditional rehabilitation strategy. | Tested by Instrumental Activity of Daily living (IDAL). |
Other
| Measure | Time frame | Description |
|---|---|---|
| The changes of brain network properties. | 1 month and 3 months after randomization. | Evaluated by fMRI before and after rehabilitaion. |
Countries
China
Outcome results
None listed