Clinical trial NCT05333497: Programmed Flexor-extensor Alternating Electrical Acupiont Stimulation on Limb Functional Reconstruction After Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Sequelae
Movement Disorders
Keywords: Functional electrical stimulation
Stroke Sequelae
Movement disorders
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 84
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: EEG data record
timeFrame: 2 hours before the first treatment
measure: EEG data record
timeFrame: 2 hours after the first treatment
measure: EEG data record
timeFrame: 2 hours before the last treatment
measure: EEG data record
timeFrame: 2 hours after the last treatment
measure: EEG power spectrum analysis
timeFrame: 1 week after all the EEG data is collected
measure: sEMG data record
timeFrame: 1 hour before the first treatment
measure: sEMG data record
timeFrame: 1 hour after the first treatment
measure: sEMG data record
timeFrame: 1 hour before the last treatment
measure: sEMG data record
timeFrame: 1 hour after the last treatment
measure: sEMG coherence analysis
timeFrame: 1 week after all the sEMG data is collected
Secondary outcomes:
measure: Scale evaluation--MBI
timeFrame: 3 hours before the whole clinical trail
measure: Scale evaluation--MBI
timeFrame: 3 hours after the whole clinical trail
measure: Scale evaluation--CSS
timeFrame: 3 hours before the whole clinical trail
measure: Scale evaluation--CSS
timeFrame: 3 hours after the whole clinical trail
measure: Scale evaluation--FMA
timeFrame: 3 hours before the whole clinical trail
measure: Scale evaluation--FMA
timeFrame: 3 hours after the whole clinical trail
measure: Scale evaluation--MMT
timeFrame: 3 hours before the whole clinical trail
measure: Scale evaluation--MMT
timeFrame: 3 hours after the whole clinical trail
measure: Scale evaluation--Brunnstrom
timeFrame: 3 hours before the whole clinical trail
measure: Scale evaluation--Brunnstrom
timeFrame: 3 hours after the whole clinical trail
Other outcomes:
measure: EEG data of healthy controls
timeFrame: 1 week before the beginning of the whole clinical trail
measure: sEMG data of healthy controls
timeFrame: 1 week before the beginning of the whole clinical trail
measure: EEG power spectrum analysis of healthy controls
timeFrame: 1 week before the beginning of the whole clinical trail
measure: sEMG synergy-coherence analysis of healthy controls
timeFrame: 1 week before the beginning of the whole clinical trail
Locations:
city: Harbin
country: China
facility: The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
state: Heilongjiang
Study officials:
affiliation: The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
name: Dongyan Wang, PhD
role: STUDY_DIRECTOR
References: