Unilateral limb dysfunction caused by cerebral infarction or cerebral hemorrhage
Conditions
Interventions
Control group:Subjects received functional electrical stimulation of the rectus femoris and tibialis anterior muscles, with each session lasting 20 min, 10 sessions per week, 2 sessions per day, for 4
Intervention group:Subjects will be instructed by a screen video to imagine performing knee extension and ankle dorsiflexion movements with the affected lower limb. Non-invasive EEG acquisition device
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients clinically diagnosed with first-ever unilateral hemispheric stroke, confirmed by MRI or CT as either hemorrhagic or ischemic stroke, with a lesion located in one cerebral hemisphere; 2.Adult subjects (18-80 years old). 3.Brunnstrom Stage II-IV; 4.Stroke onset between 2 weeks and 6 months; 5.Lower limb muscle tone with a Modified Ashworth Scale (MAS) grade = 22; 7.Informed consent obtained from the patient or their immediate family member;
Exclusion criteria
Exclusion criteria: 1.Inability to comprehend or cooperate due to severe aphasia, cognitive impairment, or psychiatric disorders; 2.Brainstem or cerebellar lesions; 3.Any condition that interferes with the use of the EEG cap, such as skull defects or open wounds; 4.Presence of metal implants; 5.Skin breakdown, inflammation, or hypersensitivity at the intended stimulation site; 6.Presence of lower limb venous thrombosis assessed as posing a risk to the safety of rehabilitation therapy; 7.Restricted lower limb mobility or Achilles tendon contracture (ankle dorsiflexion PROM < 0°); 8.History of epilepsy; 9.Unstable vital signs or severe cardiopulmonary disease (e.g., acute myocardial infarction, severe COPD); 10.Recent use of short-acting medications (e.g., benzodiazepines) within the past 2 weeks, or long-acting medications (e.g., fluoxetine) within the past 6 weeks; 11.Concurrent participation in other clinical trials; 12.Pregnancy or lactation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the Fugl-Meyer Assessment for Lower Extremity (FMA-LE) score from baseline to post-intervention; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Modified Barthel Index score from baseline at post-intervention and 3-month follow-up;Modified Ashworth Scale (MAS) at post-intervention and 3-month follow-up;Change in Berg Balance Scale score from baseline at post-intervention and 3-month follow-up;The change in the Fugl-Meyer Assessment for Lower Extremity (FMA-LE) score from baseline to the 3-month follow-up;Functional ambulation category scale at post-intervention and 3-month follow-up; | — |
Countries
China
Contacts
Public ContactHou Jingming
The First Affiliated Hospital of Army Medical University
Outcome results
None listed