Adding the Transcutaneous Electrical Nerves Stimulation for Acute Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The score-change of the Functional Independence Measure (FIM) for activity of daily living function
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria:
- •the patient who suffer from first stroke was admitted to the stroke center of National Taiwan University Hospital (NTUH) within 3 days of onset
- •National Institutes of Health Stroke Scale (NIHSS) scores ranging from 5 to 25
- •totally activity of daily living independent before stroke onset;
- •between 40-80 years old;
- •stroke with unilateral hemiparesis lesions confirmed by magnetic resonance imaging (MRI) or computed tomography (CT), with vascular lesions verified by magnetic resonance angiography (MRA);
- •a cortical or subcortical infarction or hemorrhage;
- •no other peripheral or central nervous system dysfunction;
- •no active inflammation or pathologic changes in the joints;
- •no active medical problems.
排除标准
- •medical conditions unrelated to the cerebrovascular accident but which had affected walking performance
- •other cognitive, emotional, or behavioral impairments that result in insufficient comprehension, understanding, or collaboration
- •medical problems potentially adversely affected by electric stimulation
- •had skin conditions, or had allergies etc.
研究组 & 干预措施
TENS+SR
For each participant in the transcutaneous nerve stimulation (TENS) group, standard rehabilitation (SR) in addition a TENS stimulator (BioTENS, Skylark Device & Systems Co., Ltd) was applied with 0.2-ms pulses at 100 Hz in the constant mode within the subject's sensory level without muscle contraction via (5 × 3.5 cm) electrodes attached to the motor points of the tibia anterior (TA) and quadriceps muscles on the affected lower extremity. For the TENS group, the given electric stimulation treatment lasted for 30 min per session, once per day, 5 days a week, for 2 weeks.
干预措施: transcutaneous nerve stimulation (TENS) (Device)
TENS+SR
For each participant in the transcutaneous nerve stimulation (TENS) group, standard rehabilitation (SR) in addition a TENS stimulator (BioTENS, Skylark Device & Systems Co., Ltd) was applied with 0.2-ms pulses at 100 Hz in the constant mode within the subject's sensory level without muscle contraction via (5 × 3.5 cm) electrodes attached to the motor points of the tibia anterior (TA) and quadriceps muscles on the affected lower extremity. For the TENS group, the given electric stimulation treatment lasted for 30 min per session, once per day, 5 days a week, for 2 weeks.
干预措施: standard rehabilitation (SR) (Other)
FES + SR
For each participant in the functional electrical stimulation (FES) group, standard rehabilitation (SR) in addition two dual-channel FES stimulators (MEDTRONIC Respond Select; EmpiInc) were used. The FES was delivered with 0.3-ms pulses at 30 pps and the stimulation intensity was set to the movement threshold to induce visible muscle contractions. For the FES group, the given electric stimulation treatment lasted for 30 min per session, once per day, 5 days a week, for 2 weeks.
干预措施: functional electrical stimulation (FES) (Device)
FES + SR
For each participant in the functional electrical stimulation (FES) group, standard rehabilitation (SR) in addition two dual-channel FES stimulators (MEDTRONIC Respond Select; EmpiInc) were used. The FES was delivered with 0.3-ms pulses at 30 pps and the stimulation intensity was set to the movement threshold to induce visible muscle contractions. For the FES group, the given electric stimulation treatment lasted for 30 min per session, once per day, 5 days a week, for 2 weeks.
干预措施: standard rehabilitation (SR) (Other)
SR-only
All the participants received functional training and motor relearning physiotherapy treatment as early standard rehabilitation (SR) for 30 minutes per day, 5 days a week throughout the study. Subjects in the SR group received only SR .
干预措施: standard rehabilitation (SR) (Other)
结局指标
主要结局
The score-change of the Functional Independence Measure (FIM) for activity of daily living function
时间窗: 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.
次要结局
- 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)