Adding the Transcutaneous Electrical Nerves Stimulation for Acute Stroke Rehabilitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Stroke Intervention
- Sponsor
- National Taiwan University Hospital
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- The score-change of the Functional Independence Measure (FIM) for activity of daily living function
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The score-change of the Functional Independence Measure (FIM) for activity of daily living function
Time Frame: baseline and 2-week, 4-week after stroke
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.
Secondary Outcomes
- The number of days required to achieve 50-m walking motor milestones(within 4 weeks from stroke onset)
- Modified Ashworth scale for affected ankle plantar-flexors spasticity measurement(baseline and 2-week, 4-week after stroke)
- Maximum isometric voluntary contraction (MIVC) of hip flexors, knee extensors and ankle dorsiflexors for measuring the improvement of affected muscle strength(baseline and 2-week, 4-week after stroke)
- the Timed Up & Go (TUG) test for functional mobility ability(baseline and 2-week, 4-week after stroke)
- the 10-meters walking test (10MWT) for walking speed evaluation(baseline and 2-week, 4-week after stroke)
- The number of days required to achieve 5-mins sitting motor milestones from the Postural Assessment Scale for Stroke Patients (PASS)(within 4 weeks from stroke onset)
- The number of days required to achieve 1-mins standing motor milestones from the Postural Assessment Scale for Stroke Patients (PASS)(within 4 weeks from stroke onset)