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Completed

NCT Number: NCT05333497

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

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.

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Key information

Conditions

Stroke Sequelae Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150001, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

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.

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

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.

Other names: patent No. : ZL201610793646.9

Primary outcomes

  1. EEG data record

    Time frame: 2 hours before the first treatment

    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.

  2. EEG data record

    Time frame: 2 hours after the first treatment

    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.

  3. EEG data record

    Time frame: 2 hours before the last treatment

    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.

  4. EEG data record

    Time frame: 2 hours after the last treatment

    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.

  5. EEG power spectrum analysis

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

    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.

  6. sEMG data record

    Time frame: 1 hour before the first treatment

    Ask the patients to do the "reaching and retriving" gross movement, recording the real-time sEMG data of RMS (root mean square) and MF (median frequency) 1 hour before the first treatment.

    sEMG cosynergive-coherence analysis: The signals are collected with the sEMG device (H4A2L8), developed by ThoughtTechnology Ltd, Canada.

    Datas are respectively collected of the biceps brachii and triceps brachii muscles during the whole process of the motion. Computer software calculates iEMG (integral electromyogram) and MPF (mean power frequency) values.

  7. sEMG data record

    Time frame: 1 hour after the first treatment

    Ask the patients to do the "reaching and retriving" gross movement, recording the real-time sEMG data of RMS and MF 1 hour after the first treatment.

    sEMG cosynergive-coherence analysis: The signals are collected with the sEMG device (H4A2L8), developed by ThoughtTechnology Ltd, Canada.

    Datas are respectively collected of the biceps brachii and triceps brachii muscles during the whole process of the motion. Computer software calculates iEMG and MPF values.

  8. sEMG data record

    Time frame: 1 hour before the last treatment

    Ask the patients to do the "reaching and retriving" gross movement, recording the real-time sEMG data of RMS and MF 1 hour before the last treatment.

    sEMG cosynergive-coherence analysis: The signals are collected with the sEMG device (H4A2L8), developed by ThoughtTechnology Ltd, Canada.

    Datas are respectively collected of the biceps brachii and triceps brachii muscles during the whole process of the motion. Computer software calculates iEMG and MPF values.

  9. sEMG data record

    Time frame: 1 hour after the last treatment

    Ask the patients to do the "reaching and retriving" gross movement, recording the real-time sEMG data of RMS and MF 1 hour after the last treatment.

    sEMG cosynergive-coherence analysis: The signals are collected with the sEMG device (H4A2L8), developed by ThoughtTechnology Ltd, Canada.

    Datas are respectively collected of the biceps brachii and triceps brachii muscles during the whole process of the motion. Computer software calculates iEMG and MPF values.

  10. sEMG coherence analysis

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

    sEMG coherence analysis: Local mean decomposition (LMD) de-noising methods and non-negative matrix decomposition algorithm are used and cosynergive-coherence analysis of the muscle pairs participating in the programmed motion is analyzed, to study the effects of different electrical stimulation methods on the motor coordination and the central control mechanism.

Secondary outcomes

  1. Scale evaluation--MBI

    Time frame: 3 hours before the whole clinical trail

    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.

  2. Scale evaluation--MBI

    Time frame: 3 hours after the whole clinical trail

    The same as above.

  3. Scale evaluation--CSS

    Time frame: 3 hours before the whole clinical trail

    CSS (China Stroke Scale): A neurological deficits assessment. Normal (45 points), Upper limb normal (12 points). Each activity of upper limb is rated on a scale of 7 (0~6 points). The lower the score, the better the situation is.

    CSS 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.

  4. Scale evaluation--CSS

    Time frame: 3 hours after the whole clinical trail

    The same as above.

  5. Scale evaluation--FMA

    Time frame: 3 hours before the whole clinical trail

    FMA (Fugl-Meyer Assessment): A motor function assessment. Normal (226 points), Upper limb normal (66 points, 33 items). The high the score, the better the situation is.

    FMA scale 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.

  6. Scale evaluation--FMA

    Time frame: 3 hours after the whole clinical trail

    The same as above.

  7. Scale evaluation--MMT

    Time frame: 3 hours before the whole clinical trail

    MMT (Manual Muscle Testing): A muscle strength assessment. Normal (level 5) with a minimum of 0 (no muscle contraction) and a maximum of 5 (normal, can resist gravity and sufficient resistance). The higher the score, the more normal muscle strength tends to be.

    FMA scale 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.

  8. Scale evaluation--MMT

    Time frame: 3 hours after the whole clinical trail

    The same as above.

  9. Scale evaluation--Brunnstrom

    Time frame: 3 hours before the whole clinical trail

    Brunnstrom motor function assessment: A limb function recovery assessment. Normal (level 6) with a minimum of 1 (no movement) and a maximum of 6 (basiclly normal). The higher the level, the better recovery is.

    Brunnstrom scale 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.

  10. Scale evaluation--Brunnstrom

    Time frame: 3 hours after the whole clinical trail

    The same as above.

Other outcomes

  1. EEG data of healthy controls

    Time frame: 1 week before the beginning of the whole clinical trail

    To record the immediate Alpha, Beta, Delta and Theta bands of the eyes-closed resting state EEG of the healthy controls in a quiet without any interference laboratory.

  2. sEMG data of healthy controls

    Time frame: 1 week before the beginning of the whole clinical trail

    Ask them to do the "reaching and retriving" gross movement, recording the real-time sEMG parameters (RMS and MF) of biceps brachii and triceps brachii muscles during the whole process of the motion. Computer software calculates iEMG and MPF values.

  3. EEG power spectrum analysis of healthy controls

    Time frame: 1 week before the beginning of the whole clinical trail

    EEG power spectrum analysis is made to evaluate the brain energy state, for better interpreting the movement control strategy of the central nervous system, providing a reference for the prognosis of patients and the curative effect evaluation.

  4. sEMG synergy-coherence analysis of healthy controls

    Time frame: 1 week before the beginning of the whole clinical trail

    sEMG synergy-coherence analysis is made to evaluate the degree of muscle coordination, for better interpreting the movement control strategy of the central nervous system, providing a reference for the prognosis of patients and the curative effect evaluation.

Sponsors and collaborators

Lead sponsor

Yang Liu

Other

Registry information

Official study title

Study on the Effect Mechanism of Programmed Flexor-extensor Alternating Electrical Acupiont Stimulation on Upper Limb Functional Reconstruction After Stroke: Study Protocol for a Randomized Controlled Trail

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 19, 2022
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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