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

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

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.

Study Overview

• Status: Completed
• Conditions: Movement Disorders; Stroke Sequelae
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	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.; Other Names: patent No. : ZL201610793646.9
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	1 week after all the EEG data is collected
sEMG data record	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.	1 hour before the first treatment
sEMG data record	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.	1 hour after the first treatment
sEMG data record	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.	1 hour before the last treatment
sEMG data record	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.	1 hour after the last treatment
sEMG coherence analysis	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.	1 week after all the sEMG data is collected

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 hours before the whole clinical trail
Scale evaluation--MBI	The same as above.	3 hours after the whole clinical trail
Scale evaluation--CSS	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.	3 hours before the whole clinical trail
Scale evaluation--CSS	The same as above.	3 hours after the whole clinical trail
Scale evaluation--FMA	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.	3 hours before the whole clinical trail
Scale evaluation--FMA	The same as above.	3 hours after the whole clinical trail
Scale evaluation--MMT	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.	3 hours before the whole clinical trail
Scale evaluation--MMT	The same as above.	3 hours after the whole clinical trail
Scale evaluation--Brunnstrom	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.	3 hours before the whole clinical trail
Scale evaluation--Brunnstrom	The same as above.	3 hours after the whole clinical trail

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG data of healthy controls	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.	1 week before the beginning of the whole clinical trail
sEMG data of healthy controls	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.	1 week before the beginning of the whole clinical trail
EEG power spectrum analysis of healthy controls	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.	1 week before the beginning of the whole clinical trail
sEMG synergy-coherence analysis of healthy controls	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.	1 week before the beginning of the whole clinical trail

Collaborators and Investigators

• Sponsor: Yang Liu
• Investigators: Study Director: Dongyan Wang, PhD, The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): April 18, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Movement disorders; Functional electrical stimulation; Stroke Sequelae
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Movement Disorders
• Other Study ID Numbers: HeilongjiangUCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will be based on actual situation in future.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No