Effect of Mirror Therapy with Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in People with Stroke: a Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Change of Fugl-Meyer Assessment of Lower Extremity (FMA-LE)
研究概览
简要总结
This study aims to evaluate the effectiveness of concurrent mirror therapy (MT) and transcutaneous electrical nerve stimulation (TENS) in augmenting the efficacy of the lower limb task-oriented training in people with stroke. It is hypothesize that MT combined with TENS would be superior to sham-mirror therapy with TENS, or MT with placebo-TENS, or control training only in improving lower limb motor functions and walking ability in people with stroke when combined with the lower limb task-oriented training.
详细描述
The application of transcutaneous electrical nerve stimulation (TENS) over a paretic lower limb could augment the effects of task-oriented exercise therapy on lower limb motor function in people with stroke, possibly through increased excitability of sensorimotor cortex.
In mirror therapy (MT), the intact limb performs motor tasks while its mirror reflection is superimposed over the covered paretic limb, creating a visual illusion of enhanced function over the paretic limb. The visual input during MT could substitute for reduced proprioceptive inputs and increase spatial attention of the paretic limb, which could improve motor function of the paretic limb, possibly through increased cortical activity in the lesioned hemisphere and mirror neurone system.
The next question concerns whether MT could be combined with TENS and whether their synergetic effects could maximise the motor output of paretic limbs in people with stroke.
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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have had a single stroke with ischemic brain injury or intracerebral haemorrhage diagnosed by magnetic resonance imaging or computed tomography within the previous 6 to 36 months;
- •have at least 5 degrees of active ankle dorsiflexion in the antigravity position;
- •are able to walk 10 m independently with or without a walking aid;
- •are able to score 6 or higher out of 10 on the abbreviated mental test;
- •have no unilateral neglect, hemianopia or apraxia;
- •have no skin allergy (e.g. redness or itchiness to the electrical stimulation pads) to electrical stimulation or electrodes; and
- •are able to follow instructions and give informed consent.
排除标准
- •have any additional medical, cardiovascular or orthopaedic condition that would hinder proper treatment or assessment;
- •have visual deficits that may hinder them from benefiting from the mirror visual feedback;
- •have receptive dysphasia; or
- •are involved in drug studies or other clinical trials.
结局指标
主要结局
The Change of Fugl-Meyer Assessment of Lower Extremity (FMA-LE)
时间窗: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
FMA-LE is used to evaluate the lower extremity motor control, including reflexes, voluntary control of isolated movement and coordination. The scale score ranging from 0 to 34, with 17 items and ordinal scoring from 0 to 2. A higher score indicates a better lower extremity motor control. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
次要结局
- The Change of Paretic ankle dorsiflexor strength(Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks))
- The Change of Paretic ankle plantarflexor strength(Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks))
- The Change of 10-m walk test(Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks))
- The Change of Timed 'Up and Go' test(Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks))
- The Change of Lower-extremity motor co-ordination test(Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks))
- The Change of Cantonese version of Community Integration Measures (CIM-C)(Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks))
研究者
Shamay Ng
Associate Professor
The Hong Kong Polytechnic University