Effectiveness of Vibration Training on Muscle Strength of Lower Limbs, Functional Recovery, and Mood State Among Patients With Acute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- neurologic disability
研究概览
简要总结
This study aims to exam the effectiveness of vibration training on muscle strength of lower limbs, functional recovery, and mood state among patients with acute stroke.
详细描述
There remains challenging for improving functional recovery of stroke patients in the acute post-stroke period among patients with acute stroke. Particularly the effectiveness of early rehabilitation combining with vibration training for patients with acute stroke is unknown.
Therefore, this study aims to exam the effectiveness of vibration training on muscle strength of lower limbs, functional recovery, and mood state among patients with acute stroke.
A randomized controlled trial will be conducted. Patients with acute ischemic stroke will be selected and randomly assigned to either control group (CG), exercise group (EG), wearable leg vibration training group (WG), or lower extremity vibration training group (LG). All groups will receive conventional treatment and regular rehabilitation. Neurologic disability (Modified Rankin Scale), muscle strength, functional status (Postural Assessment Scale and Barthel Scale), and mood state (Hospital Anxiety and Depression Scale) will be collected to compare between groups and pre- and post-differences.
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)
盲法说明
The outcome data will be collected by a research assistant who was blinded in group assignment.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) inpatients diagnosed with acute infarct (ischemic, e.g., large artery atherosclerosis, cardioembolism, and small vessel occlusion) stroke;
- •(2) stroke onset occurs within three days of admission;
- •(3) aged greater than 20 years and under 80 years;
- •(4) able to communicate with verbal or nonverbal methods and understand Mandarin;
- •(5) normal cognitive function (Mini-Mental State Examination≥ 21);
- •(6) neurologic disability ranged from 1 (able to execute all usual duties and activities despite some symptoms) to 4 (moderately severe , eg., unable to attend to own bodily needs without assistance, and unable to walk unassisted) score evaluated by the modified Rankin Scale (mRS);
- •(7) agreed to be randomly assigned
排除标准
- •(1) diagnosed with a transient ischemic attack combined with visual and hearing impairment;
- •(2) neurologic disability were mRS: 0 (no symptoms) or 5 score (severe disability: requires constant nursing care and attention, bedridden, incontinent) and above;
- •(3) an acute/chronic nerve or musculoskeletal injury in lower limbs, or history of bone and joint surgery of low extremities in the past six months;
- •(4) a history of cancer, end-stage renal disease with dialysis, dementia, mental health disorders (particularly major depression), based on both of medical records and assessments from the neurologist;
- •(5) patients transferred from other wards or intensive care units;
- •(6) being unable to participate due to other comorbid neurological and musculoskeletal conditions that produce moderate-to-severe physical disability;
- •(7) prolonged stay in hospital for over 21 days due to other medical comorbidities (e.g., myocardial infarction, septic shock, cancer) after admission or length of stay in hospital less than one week due to a decline to treatment and transfer to another hospital for further confirmation of diagnosis and other complementary and alternative therapies.
研究组 & 干预措施
control group
Only received conventional therapy comprised of standardized treatment and regular rehabilitation (i.e., postural training, facilitation techniques, stretching exercise, and strengthening exercise) prescribed by a rehabilitation physician and performed at 3 to 6 days after admission for five 60-minute sessions per week by the physical, occupational, and speech therapists in the rehabilitation center of the medical center.
exercise group
The exercise group will receive extra 5 days of 30-minute lower-limb ergometer exercise training in addition to the conventional therapy.
干预措施: ergometer exercise (Behavioral)
wearable leg vibration training group
The wearable leg vibration training group will receive extra 5 days of 30-minute wearable leg vibration of lower limbs combined with 30-minute lower-limb ergometer exercise training at post-vibration session, in addition to the conventional therapy.
干预措施: Vibration training (Device)
wearable leg vibration training group
The wearable leg vibration training group will receive extra 5 days of 30-minute wearable leg vibration of lower limbs combined with 30-minute lower-limb ergometer exercise training at post-vibration session, in addition to the conventional therapy.
干预措施: ergometer exercise (Behavioral)
lower-extremity weight bearing vibration training group
The lower-extremity weight bearing vibration training group will receive extra 5 days of 30-minute lower-extremity weight bearing vibration combined with30-minute lower-limb ergometer exercise training at post-vibration session, in addition to the conventional therapy.
干预措施: Vibration training (Device)
lower-extremity weight bearing vibration training group
The lower-extremity weight bearing vibration training group will receive extra 5 days of 30-minute lower-extremity weight bearing vibration combined with30-minute lower-limb ergometer exercise training at post-vibration session, in addition to the conventional therapy.
干预措施: ergometer exercise (Behavioral)
结局指标
主要结局
neurologic disability
时间窗: through hospitalization, an average of 14 days
neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.
Mood state
时间窗: through hospitalization, an average of 14 days
This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.
muscle strength
时间窗: through hospitalization, an average of 14 days
The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.
Functional status: Postural Assessment Scale for Stroke
时间窗: through hospitalization, an average of 14 days
The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.
Functional status: Barthel Scale
时间窗: through hospitalization, an average of 14 days
The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.
neurologic disability
时间窗: Baseline
neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.
neurologic disability
时间窗: 5 days after intervention
neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.
muscle strength
时间窗: Baseline
The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.
muscle strength
时间窗: 5 days after intervention
The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.
Functional status: Postural Assessment Scale for Stroke
时间窗: Baseline
The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.
Functional status: Postural Assessment Scale for Stroke
时间窗: 5 days after intervention
The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.
Functional status: Barthel Scale
时间窗: Baseline
The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.
Functional status: Barthel Scale
时间窗: 5 days after intervention
The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.
Mood state
时间窗: Baseline
This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.
Mood state
时间窗: 5 days after intervention
This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.
次要结局
未报告次要终点
研究者
CHIA-HUEI LIN, PhD
Associate Professor
Tri-Service General Hospital