Clinical trial NCT03304340: Comparison the Effects of Early Functional Electrical Stimulation and Transcutaneous Electrical Nerves Stimulation in Functional and Motor Recovery for Acute Stroke Patients
Official title: Adding the Transcutaneous Electrical Nerves Stimulation for Acute Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke Intervention
Keywords: acute stroke,TENS ,posture stability, function
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Based on modern knowledge about the neuro-plastic changes that occur immediately after brain injuries, rehabilitation should be more effective when started soon after brain damaged. Besides, knowledge about one of the factors that determine efficacy of rehabilitation is the commencement of treatment, as well as on the time interval from stroke to initiate voluntary movement. Therefore, many studies had reported that the effectiveness of functional electrical stimulation (FES) and transcutaneous electrical nerves stimulation (TENS), which induce stimulation and the excitability, were widely applied in rehabilitation for patients with stroke. However, many investigations about the effects of FES or TENS on motor recovery for the stroke patients mainly focus on the chronic stage as well as compared each of two different kinds of stimulation separately. Hence the investigators will study the impacts of TENS and FES on the motor recovery for the stroke patients from the acute stage. Bedsides, the investigators also study that whether patients after stroke in the acute stage who received adding TENS experienced similar impacts on motor recovery to those who received adding FES.

This was a single-blind randomized control trial study. The study recruited 40 subjects from stroke center of National Taiwan Hospital (NTUH) within 3 days after first stroke onset. All subjects were in stable medically control and assigned randomly to 1 of 3 groups including (1)Functional electrical stimulation (FES) + standard rehabilitation (SR) ,(2) Transcutaneous electrical nerves stimulation (TENS) + SR or (3)SR only (control group).The application of FES and TENS was used for 30 minutes per day, 5 days per week for 2 weeks. The surface electrodes of two dual channels were applied on tibialis anterior and quadriceps for FES and TENS group. All groups received SR including neuro-facilitation and functional task training etc.

Outcome measurements were analyzed with repeated measure analysis of variance using SPSS to compare the main effects before, during, and after treatment, followed by post-hoc tests with Bonferroni correction to compare treatment effects among the 3 groups. For categorical variables, a X2 test was used. The significance level was set at 5% (2-tailed).

Eligibility criteria: 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.

Primary outcomes:
measure: The score-change of the Functional Independence Measure (FIM) for activity of daily living function
timeFrame: baseline and 2-week, 4-week after stroke
Secondary outcomes:
measure: Modified Ashworth scale for affected ankle plantar-flexors spasticity measurement
timeFrame: baseline and 2-week, 4-week after stroke
measure: Maximum isometric voluntary contraction (MIVC) of hip flexors, knee extensors and ankle dorsiflexors for measuring the improvement of affected muscle strength
timeFrame: baseline and 2-week, 4-week after stroke
measure: the Timed Up & Go (TUG) test for functional mobility ability
timeFrame: baseline and 2-week, 4-week after stroke
measure: the 10-meters walking test (10MWT) for walking speed evaluation
timeFrame: baseline and 2-week, 4-week after stroke
measure: The number of days required to achieve 5-mins sitting motor milestones from the Postural Assessment Scale for Stroke Patients (PASS)
timeFrame: within 4 weeks from stroke onset
measure: The number of days required to achieve 1-mins standing motor milestones from the Postural Assessment Scale for Stroke Patients (PASS)
timeFrame: within 4 weeks from stroke onset
measure: The number of days required to achieve 50-m walking motor milestones
timeFrame: within 4 weeks from stroke onset
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Test2
Study officials:
affiliation: School institute of Physical Therapy, National Taiwan University
name: Jer-Junn Lun, PhD
role: PRINCIPAL_INVESTIGATOR
References: