Acute Stroke Intervention Clinical Trial
Official title:
Adding the Transcutaneous Electrical Nerves Stimulation for Acute Stroke Rehabilitation
Verified date | September 2017 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to examine the outcomes of postural stability, activities of daily living function, and motor capacity of persons after stroke who received transcutaneous electrical nerves stimulation (TENS) or functional electrical stimulation (FES), in addition to SR, in the post-stroke acute phase. Such persons were compared with others who received SR alone in order to determine if the addition of TENS or FES resulted in earlier or more effective recovery.
Status | Completed |
Enrollment | 42 |
Est. completion date | December 31, 2015 |
Est. primary completion date | December 31, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
The inclusion criteria: 1. the patient who suffer from first stroke was admitted to the stroke center of National Taiwan University Hospital (NTUH) within 3 days of onset 2. National Institutes of Health Stroke Scale (NIHSS) scores ranging from 5 to 25 3. totally activity of daily living independent before stroke onset; 4. between 40-80 years old; 5. stroke with unilateral hemiparesis lesions confirmed by magnetic resonance imaging (MRI) or computed tomography (CT), with vascular lesions verified by magnetic resonance angiography (MRA); 6. a cortical or subcortical infarction or hemorrhage; 7. no other peripheral or central nervous system dysfunction; 8. no active inflammation or pathologic changes in the joints; 9. no active medical problems. The exclusion criteria: 1. medical conditions unrelated to the cerebrovascular accident but which had affected walking performance 2. other cognitive, emotional, or behavioral impairments that result in insufficient comprehension, understanding, or collaboration 3. medical problems potentially adversely affected by electric stimulation 4. had skin conditions, or had allergies etc. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei | Test2 |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The score-change of the Functional Independence Measure (FIM) for activity of daily living function | The FIM with a maximum score of 116 was used to assess each patient's capacities in terms of ADL, which comprises 18 seven-level items and assesses dependence in self-care, sphincter management, transfer, locomotion, communication, social interaction and cognition. | baseline and 2-week, 4-week after stroke | |
Secondary | Modified Ashworth scale for affected ankle plantar-flexors spasticity measurement | The Modified Ashworth Scale (MAS) measures muscle hypertonia with 5-level grades including 1) no increase in muscle tone; 2) slight increase giving a catch when part is moved in flexion or extension; 3) more marked increase in tone but only after part is easily flexed; 4) considerable increase in tone; and 5) passive movement is difficult and affected part is rigid in flexion or extension. | baseline and 2-week, 4-week after stroke | |
Secondary | Maximum isometric voluntary contraction (MIVC) of hip flexors, knee extensors and ankle dorsiflexors for measuring the improvement of affected muscle strength | Maximum isometric voluntary contraction (MIVC) of the ankle quadriceps, dorsiflexor, plantarflexor muscles was recorded by handheld dynamometer in supine position. | baseline and 2-week, 4-week after stroke | |
Secondary | the Timed Up & Go (TUG) test for functional mobility ability | the Timed Up and Go Test was used to measure the walking time. Patients went from sitting to standing, walked three meters at a fast, comfortable speed, turned around, walked back, and sat down again. The patients were allowed to use his/her own walking aids, but no physical assistance was given by the researcher or therapist. The patients were also allowed to practice one or two trials in order to comprehend the whole test procedure. The mean time (in seconds) across three trials was used as the walking time. | baseline and 2-week, 4-week after stroke | |
Secondary | the 10-meters walking test (10MWT) for walking speed evaluation | Individual walks without assistance 10 meters and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration. | baseline and 2-week, 4-week after stroke | |
Secondary | The number of days required to achieve 5-mins sitting motor milestones from the Postural Assessment Scale for Stroke Patients (PASS) | The first milestone was the ability to sit on the edge of the bed with the feet touching the floor without support > 5 minutes (PASS subtest: maintaining posture, sitting without support, grade 3). | within 4 weeks from stroke onset | |
Secondary | The number of days required to achieve 1-mins standing motor milestones from the Postural Assessment Scale for Stroke Patients (PASS) | The second milestone was the ability to stand without support for longer than 1 minute (PASS subtest: maintaining posture, standing without support, grade 3) | within 4 weeks from stroke onset | |
Secondary | The number of days required to achieve 50-m walking motor milestones | The third milestone involved walking on a level surface for a minimum of 50 m with/without an assistive device under supervision for safety. | within 4 weeks from stroke onset |