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

Yang Liu

Status: Completed

Conditions: Movement Disorders; Stroke Sequelae

Treatments: Device: the fourth programmed generation of low-frequency acupoint electric stimulation therapy instrument; Device: the fourth generation of low-frequency acupoint electric stimulation therapy instrument

Study type: Interventional

Funder types: Other

Identifiers

NCT05333497

HeilongjiangUCM

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 84 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 3 patient groups

Programmed acupiont stimulation group

Experimental group

Description:

On the basis of routine treatment in the Department of Acupuncture, the fourth generation of low-frequency acupoint electric stimulation therapy instrument (patent No. : ZL201610793646.9) jointly developed by our research group and the Robotics Institute of Harbin Institute of Technology is used to improve the program. The output of the improved instrument program is: the patient should complete the program of "reaching and retrieving", namely shoulder joint forward flexion - elbow extension - wrist dorsal extension - finger extension (" reaching for objects "), then grasping - wrist flexion - elbow flexion - shoulder joint backward extension (" retrieve objects "). All patients were in a sitting position, the wrist of the affected limb is suspended, and the other parts do not touch any plane.

Treatment:

Device: the fourth programmed generation of low-frequency acupoint electric stimulation therapy instrument

Conventional acupiont stimulation group

Active Comparator group

Description:

On the basis of the basic treatment in the Department of Acupuncture, the output mode of the fourth generation of low-frequency acupoint electric stimulation instrument of the original program is adopted to synchronously stimulate the flexor and extensor acupoints respectively. The selection of acupoints, treatment time and course of treatment were the same as those of the programmed acupoint electric stimulation group.

Treatment:

Device: the fourth generation of low-frequency acupoint electric stimulation therapy instrument

Healthy controls

No Intervention group

Description:

No treatment. Ask them to do the "reaching and retrieving" gross motor and record the resting brain electrical and motion state of electrical parameters. Brain electric power spectrum analysis and electromyography synergy - coherence analysis are made to evaluate the brain energy state and degree of muscle coordination, for better interpreting the movement of the central nervous system control strategy and providing a reference for the prognosis of patients and the curative effect evaluation.