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

NCT05333497 | Completed

• 1 other identifier: HeilongjiangUCM
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae; Movement Disorders

Keywords

Functional electrical stimulation; Stroke Sequelae; Movement disorders

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (10)

• Scale evaluation--MBI

  3 hours before the whole clinical trail

• Scale evaluation--MBI

  3 hours after the whole clinical trail

• Scale evaluation--CSS

  3 hours before the whole clinical trail

• Scale evaluation--CSS

  3 hours after the whole clinical trail

• Scale evaluation--FMA

  3 hours before the whole clinical trail

Other Outcomes (4)

• EEG data of healthy controls

  1 week before the beginning of the whole clinical trail

• sEMG data of healthy controls

  1 week before the beginning of the whole clinical trail

• EEG power spectrum analysis of healthy controls

  1 week before the beginning of the whole clinical trail

Study Arms (3)

Programmed acupiont stimulation group

EXPERIMENTAL

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 acupiont stimulation group

ACTIVE COMPARATOR

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

Healthy controls

NO INTERVENTION

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.

Interventions

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.

Programmed acupiont stimulation group

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.

Also known as: patent No. : ZL201610793646.9

Conventional acupiont stimulation group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yang Liu: lead

Study Sites (1)

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150001, China

Location

Related Publications (1)

• 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.

  PMID: 37170159 DERIVED

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dongyan Wang, PhD

  The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending doctor

Model Details: In addition to the control and treatment groups (30 cases in each group), healthy subjects (30 cases) also provided sEMG and EEG data for reference.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 19, 2022
• Study Start: April 18, 2022
• Primary Completion: April 18, 2022
• Study Completion: February 1, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)