Programmed Flexor-extensor Alternating Electrical Acupiont Stimulation on Limb Functional Reconstruction After Stroke

Yang Liu84 enrolled

Overview

The purpose of this study is to study the effect mechanism of programmed flexor-extensor alternating electrical acupiont stimulation on upper limb functional reconstruction after stroke.

After being informed about the study and potential risks, all patients who meet the inclusion criteria, after signing the informed consent, will be randamized divided into two groups in a blind manner. The patients will undergo a 3-week treatment (6 days per week and 1 day for rest, a total of 18 days of treatment). Those in the control group are treated with conventional flexor-extensor alternating electrical acupiont stimulation, and in the treatment group, programmed stimulation will be adopted (30 minutes, once a day). Besides, data from healthy participants will be collected and processed for reference and control purposes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke Sequelae Movement Disorders

Interventions

the fourth programmed generation of low-frequency acupoint electric stimulation therapy instrumentDEVICE

Conventional electrical stimulation does not produce coordinated movement of multiple joints by stimulating several locally generated single ones simultaneously. The stimulation after the improved program, through different time output electrical stimulation on different parts of the muscles or muscle groups, forming the programmed motion. The purpose of this study is to achieve the rehabilitation goal of single joint - multiple joint - extensive movement, promote the coordination recovery of affected limb movement and relieve muscle fatigue.

the fourth generation of low-frequency acupoint electric stimulation therapy instrumentDEVICE

In this study, the instrument of alternate acupoint electrical stimulation of flexor and extensor muscles combines traditional acupoint therapy with modern low-frequency electric stimulation technology, has the advantages of non-invasive and convenient application, and has a good effect on improving the range of motion of joints, relieving spasm, enhancing muscle strength, promoting the recovery of the central nervous system and other aspects.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Inclusion criteria for patients 1. Meet the diagnostic criteria of stroke; 2. Age: 35 \~75 years old, male and female; 3. Course of disease: 2 weeks to 3 months after stroke, stable vital signs, basically normal cognitive function, can cooperate to complete the test; 4. Manual muscle test (MMT) ≥2, modified Ashworth (MAS) of paralyzed upper limbs was graded Ⅰ\~Ⅱ; 5. BMI ≤28; 6. No serious heart, lung, kidney and other functional damage and serious underlying diseases, no pain in the affected side of the upper limb joint; 7. The informed consent was signed by the patient and/or his/her family members. Note: Patients who meet the above 7 criteria can be included in this study. * Inclusion criteria for healthy subjects: 1. Those who have been proved to be healthy by physical examination and have no organic lesions or obvious functional diseases; 2. Age: 35 \~75 years old, male and female; 3. No cold, fever, cough, headache and other physical abnormalities during the test; 4. Did not take any excitatory drugs in the past one month, no recent treatment related to experimental content; 5. No history of mental or nervous system; 6. The subject agrees and signs the informed consent. * Exclusion Criteria: 1. Severe cognitive dysfunction, severe aphasia, can not cooperate with the whole treatment or testing process; 2. Patients with serious primary diseases such as heart, lung, kidney, liver and endocrine system; 3. Neurological or musculoskeletal diseases affecting functional recovery before onset; 4. Cerebral stem stroke or bilateral stroke; 5. Patients with severe anxiety, depression, affective disorders, schizophrenia and other serious mental disorders; 6. Examination confirmed by brain tumor, brain trauma, brain parasitic diseases, metabolic disorders, rheumatic heart disease, coronary heart disease and other heart disease with atrial fibrillation caused by cerebral embolism; 7. Patients with skin damage, infection or deformity at the treatment site.

Locations (1)

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Outcomes

Primary Outcomes

EEG data record

To record the immediate Alpha, Beta, Delta and Theta bands of the eyes-closed resting state EEG of patients in the two groups 2 hours before the first treatment. The EmotivEpoc wireless portable EEG device (developed by Neurotechnology Company, USA) is used to collect EEG data.

Time frame: 2 hours before the first treatment

EEG data record

To record the immediate Alpha, Beta, Delta and Theta bands of the eyes-closed resting state EEG of patients in the two groups 2 hours after the first treatment. The EmotivEpoc wireless portable EEG device (developed by Neurotechnology Company, USA) is used to collect EEG data.

Time frame: 2 hours after the first treatment

EEG data record

To record the immediate Alpha, Beta, Delta and Theta bands of the eyes-closed resting state EEG of patients in the two groups 2 hours before the last treatment. The EmotivEpoc wireless portable EEG device (developed by Neurotechnology Company, USA) is used to collect EEG data.

Time frame: 2 hours before the last treatment

EEG data record

To record the immediate Alpha, Beta, Delta and Theta bands of the eyes-closed resting state EEG of patients in the two groups 2 hours after the last treatment. The EmotivEpoc wireless portable EEG device (developed by Neurotechnology Company, USA) is used to collect EEG data.

Time frame: 2 hours after the last treatment

EEG power spectrum analysis

EEG power spectrum analysis: EEG data of the four time points as above are preprocessed on the MATLAB platform. And the analysis is used to objectively evaluate the immediate and cumulative effects of different treatment therapies on cerebral cortex activity by Alpha, Beta, Delta and Theta frequency bands.

Time frame: 1 week after all the EEG data is collected

sEMG data record

Data from ClinicalTrials.gov

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Secondary Outcomes

Scale evaluation--MBI

MBI (Modified Barthel Index): A daily functional activity assessment. Normal (100 points). Each activity is rated on a scale of 5 (5 points), with a minimum of 1 (full dependence) and a maximum of 5 (full independence). The higher the level, the more independent the activity is. MBI score of upper limb is evaluated and SPSS26.0 statistical software is used for analysis. A two-sided test is used in this study, and the significance level is p\<0.05. Parametric method is used when data conditions meet parametric conditions; non-parametric method is used when data conditions do not meet time parameter conditions.

Time frame: 3 hours before the whole clinical trail

Scale evaluation--MBI

The same as above.