Efficacy of Bilateral Stimulation With Task-oriented Training in Improving Lower Limb Motor Functions in Patients With Stroke: a Randomized, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Muscle strength of lower limb
研究概览
简要总结
This proposed study aims to compare the effects of unilateral and bilateral transcutaneous electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS + task-oriented training (TOT) with unilateral TENS+TOTin improving muscle strength, co-ordination, dynamic standing balance, walking performance, and functional mobility in patients with chronic stroke.
The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not significantly different in promoting the recovery of these functions.
详细描述
This proposed study aims to compare the effects of unilateral and bilateral transcutaneous electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS + task-oriented training (TOT) with unilateral TENS+TOTin improving muscle strength, co-ordination, dynamic standing balance, walking performance, and functional mobility in patients with chronic stroke.
The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not significantly different in promoting the recovery of these functions.
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
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be recruited from local self-help groups through poster advertising. \
- •Subjects will be included if they (1) are between 55 and 85 years of age
- •Have been diagnosed with ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography within the previous 1 to 10 years
- •Are able to walk 3 metres independently with or without a walking aid
- •Are able to score > 6 out of 10 on the abbreviated mental test
- •Are able to follow instructions and give informed consent
- •Have no skin allergy which would prevent electrical stimulation.
排除标准
- •Subjects will be excluded if they have any additional medical, cardiovascular or orthopedic condition that would hinder proper treatment or assessment
- •Use a cardiac pacemaker
- •Have receptive dysphasia
- •Have significant lower limb peripheral neuropathy (e.g. diabetic polyneuropathy)
- •Are involved in drug studies or other clinical trials.
研究组 & 干预措施
1. Bilateral TENS (Bi-TENS) group
Subjects having bilateral electrical stimulation and task-orientated exercises
干预措施: TENS and Task-orientated training (Behavioral)
Unilateral TENS (Uni-TENS) group
Subjects having unilateral TENS over their affected lower limb only, and task-oriented exercises
干预措施: TENS and Task-orientated training (Behavioral)
结局指标
主要结局
Muscle strength of lower limb
时间窗: 4 years
The strength of maximum isometric voluntary contraction of the subject's knee extensors and flexors, ankle dorsiflexors, and plantarflexors (in kilograms) will be measured bilaterally using a Nicholas handheld dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) with standardized testing positions and dynamometer placement. Good to excellent reliability (ICC range, 0.84 -0.99) has been reported for lower-limb hand-held dynamometer strength measurements of subjects with neurologic conditions \[49\]. Each subject will complete three trials in which maximal force is generated for 2 to 3 seconds ffrom each muscle. The average of the three readings will be used for data analysis.
次要结局
- Dynamic standing balance(4 years)
研究者
Shamay Ng
Associate Professor
The Hong Kong Polytechnic University