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Stroke SequelaeNCT05333497

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

A study testing the fourth programmed generation of low-frequency acupoint electric stimulation therapy instrument and the fourth generation of low-frequency acupoint electric stimulation therapy instrument in people with Stroke Sequelae and Movement Disorders, run by Yang Liu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Stroke Sequelae, Movement Disorders
What is being tested?
the fourth programmed generation of low-frequency acupoint electric stimulation therapy instrument and the fourth generation of low-frequency acupoint electric stimulation therapy instrument
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
18 Apr 2022to 1 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

    Harbin, Heilongjiang, 150001

Other trials in China

About this study

Official 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

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.

Read the 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.

Being tested
the fourth programmed generation of low-frequency acupoint electric stimulation therapy instrument, the fourth generation of low-frequency acupoint electric stimulation therapy instrument
Keywords
Functional electrical stimulation, Stroke Sequelae, Movement disorders
Medical subject headings
Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 instrumentDevice

    Also called patent No. : ZL201610793646.9

    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.

Study groups in NCT05333497
Study groupRoleWhat they receive
Programmed acupiont stimulation groupExperimentalOn 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.
Receives: Device: the fourth programmed generation of low-frequency acupoint electric stimulation therapy instrument
Conventional acupiont stimulation groupActive comparatorOn 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.
Receives: Device: the fourth generation of low-frequency acupoint electric stimulation therapy instrument
Healthy controlsNo interventionNo 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 hours before the first treatment

  2. 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.

    Measured: 2 hours after the first treatment

  3. 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.

    Measured: 2 hours before the last treatment

  4. 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.

    Measured: 2 hours after the last treatment

  5. 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.

    Measured: 1 week after all the EEG data is collected

  6. 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.

    Measured: 1 hour before the first treatment

  7. 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.

    Measured: 1 hour after the first treatment

  8. 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.

    Measured: 1 hour before the last treatment

  9. 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.

    Measured: 1 hour after the last treatment

  10. 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.

    Measured: 1 week after all the sEMG data is collected

Secondary outcomes (10)

  1. 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.

    Measured: 3 hours before the whole clinical trail

  2. Scale evaluation--MBI

    The same as above.

    Measured: 3 hours after the whole clinical trail

  3. 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.

    Measured: 3 hours before the whole clinical trail

  4. Scale evaluation--CSS

    The same as above.

    Measured: 3 hours after the whole clinical trail

  5. 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.

    Measured: 3 hours before the whole clinical trail

  6. Scale evaluation--FMA

    The same as above.

    Measured: 3 hours after the whole clinical trail

  7. 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.

    Measured: 3 hours before the whole clinical trail

  8. Scale evaluation--MMT

    The same as above.

    Measured: 3 hours after the whole clinical trail

  9. 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.

    Measured: 3 hours before the whole clinical trail

  10. Scale evaluation--Brunnstrom

    The same as above.

    Measured: 3 hours after the whole clinical trail

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2022
  2. Study start18 Apr 2022
  3. Primary completion18 Apr 2022
  4. Study completion1 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05333497
Sponsor's protocol ID
HeilongjiangUCM
Status last verified
Mar 2023
First submitted
2 Mar 2022
Last updated
20 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data sharing will be based on actual situation in future.

Publications

  • 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.

    PubMed 37170159

Questions about this trial

What is this clinical trial studying?

A study testing the fourth programmed generation of low-frequency acupoint electric stimulation therapy instrument and the fourth generation of low-frequency acupoint electric stimulation therapy instrument in people with Stroke Sequelae and Movement Disorders, run by Yang Liu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EEG data record (time frame: 2 hours before the first treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05333497, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.

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