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

NCT ID: NCT05333497

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2023-02-01

Brief Summary

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.

Detailed 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.

Conditions

Stroke Sequelae; Movement Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Programmed acupiont stimulation group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Conventional acupiont stimulation group

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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.

Healthy controls

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

Other Intervention Names

patent No. : ZL201610793646.9

Eligibility Criteria

Inclusion Criteria

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.

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yang Liu

OTHER

Sponsor Role: lead

Responsible Party

Yang Liu

attending doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dongyan Wang, PhD

Role: STUDY_DIRECTOR

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Locations

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Countries

China

References

Liu Y, Dong X, Huo H, Feng L, Tong D, Liu J, Zhang H, Zheng Y, Wang S, Wang D. Effects of programmed flexor-extensor alternating electrical acupoint stimulation on upper limb motor functional reconstruction after stroke: study protocol for a double-blind, randomized controlled trial. Trials. 2023 May 11;24(1):324. doi: 10.1186/s13063-023-07283-3.

Reference Type: DERIVED

PMID: 37170159 (View on PubMed)

Other Identifiers

HeilongjiangUCM

Identifier Type: -

Identifier Source: org_study_id