Movement Disorders, Stroke Sequelae
Conditions
Keywords
Functional electrical stimulation, Stroke Sequelae, Movement disorders
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.
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.
Interventions
DEVICEthe 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.
DEVICEthe 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.
Sponsors
Yang Liu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sEMG data record | 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. |
| EEG data record | 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. |
| EEG power spectrum analysis | 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. |
| sEMG coherence analysis | 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
| Measure | Time frame | Description |
|---|---|---|
| Scale evaluation--Brunnstrom | 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. |
| Scale evaluation--FMA | 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. |
| Scale evaluation--MBI | 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. |
| Scale evaluation--CSS | 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. |
| Scale evaluation--MMT | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| EEG data of healthy controls | 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. |
| sEMG synergy-coherence analysis of healthy controls | 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. |
| EEG power spectrum analysis of healthy controls | 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. |
| sEMG data of healthy controls | 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. |
Countries
China
Outcome results
None listed