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
Sponsor study identifier
interventional
84
1 country
1
Study Start
April 18, 2022
Actual (reported)Primary Completion
April 18, 2022
Actual (reported)Study Completion
February 1, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2, 2022
Actual (reported)April 18, 2022
Actual (reported)April 18, 2022
Actual (reported)April 19, 2022
Actual (reported)February 1, 2023
Actual (reported)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
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
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
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.
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.
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 Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150001, China
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.
Dongyan Wang, PhD
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
84 participants (actual enrollment reported by the registry).
First Submitted
March 2, 2022
First Posted
April 19, 2022
Study Start
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
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.
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.
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April 18, 2022
Primary Completion
April 18, 2022
Actual (reported)Study Completion
February 1, 2023
Actual (reported)Last Updated
March 20, 2023
Record last verified: 2023-03
Data sharing will be based on actual situation in future.
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