A Randomized Controlled Clinical Trial of Upper Limb Training with Mirror Therapy (MT) and Bilateral Transcutaneous Electrical Nerve Stimulation (Bi-TENS) to Improve Upper Limb Motor Functions in Patients with Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - post-training
研究概览
简要总结
This study compare the effectiveness of 2 rehabilitation programmes that use (1) MT with Bilateral TENS (Bi-TENS), (2) sham-MT with Bi-TENS (Bi-TENS), respectively, in addition to conventional rehabilitation of standardized upper limb training, in improving upper limb motor functions, activities of daily living, community integration, and quality of life in patients with stroke.
详细描述
The principal aim of the proposed study will be to demonstrate whether MT with Bi-TENS is more effective than sham-MT with Bi-TENS in improving upper limb motor functions, activities of daily living, community integration and quality of life in patients with stroke.
The null hypothesis will be that MT with Bi-TENS is not significantly different from sham-MT with Bi-TENS in improving upper limb motor functions, activities of daily living, community integration, and quality of life in patients 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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have been diagnosed with ischemic brain injury or intracerebral hemorrhage by MRI or computed tomography within three weeks to 10 years after the first onset of stroke;
- •have volitional control of the non-paretic arm, and at least minimal antigravity movement in the shoulder of the paretic arm;
- •have at least 5 degrees in wrist extension of the paretic arm in the antigravity position
- •are able to score > 6 of 10 of abbreviated Mental Test;
- •are able to follow instruction and give informed consent of the study.
排除标准
- •Have any additional medical, cardiovascular and orthopedic condition that would hinder the proper assessment and treatment;
- •Use cardiac pacemakers;
- •Have receptive dysphasia;
- •Have a significant upper limb peripheral neuropathy (e.g., diabetic polyneuropathy);
- •Have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm;
- •Have skin allergy that would prevent electrical stimulation;
- •Are involved in drug studies or other clinical trials.
研究组 & 干预措施
MT+ Bilateral TENS
All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of MT+bilateral TENS and 1 hour conventional training of standardized upper limb training.
干预措施: Mirror Therapy (MT) (Behavioral)
MT+ Bilateral TENS
All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of MT+bilateral TENS and 1 hour conventional training of standardized upper limb training.
干预措施: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS) (Device)
MT+ Bilateral TENS
All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of MT+bilateral TENS and 1 hour conventional training of standardized upper limb training.
干预措施: Conventional Rehabilitation Program (Behavioral)
sham-MT+ Bilateral TENS
All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of sham-MT+bilateral TENS and 1 hour conventional training of standardized upper limb training.
干预措施: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS) (Device)
sham-MT+ Bilateral TENS
All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of sham-MT+bilateral TENS and 1 hour conventional training of standardized upper limb training.
干预措施: sham-Mirror Therapy (sham-MT) (Behavioral)
sham-MT+ Bilateral TENS
All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of sham-MT+bilateral TENS and 1 hour conventional training of standardized upper limb training.
干预措施: Conventional Rehabilitation Program (Behavioral)
结局指标
主要结局
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - post-training
时间窗: 8 weeks
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - followup
时间窗: 12 weeks
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Wolf Motor Function Test (WMFT) - midterm
时间窗: 4 weeks
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
Wolf Motor Function Test (WMFT) - baseline
时间窗: Baseline (0 week)
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - baseline
时间窗: Baseline (0 week)
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - midterm
时间窗: 4 weeks
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Wolf Motor Function Test (WMFT) - post-training
时间窗: 8 weeks
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
Wolf Motor Function Test (WMFT) - followup
时间窗: 12 weeks
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
次要结局
- Grip Strength - baseline(Baseline (0 week))
- Grip Strength - post-training(8 weeks)
- Grip Strength - followup(12 weeks)
- Jacket Test - baseline(Baseline (0 week))
- Jacket Test - post-training(8 weeks)
- Motor Activity Log (MAL) - baseline(Baseline (0 week))
- Motor Activity Log (MAL) - midterm(4 weeks)
- Stroke Impact Scale (SIS) - baseline(Baseline (0 week))
- Stroke Impact Scale (SIS) - followup(12 weeks)
- Community Integration Questionnaire (CIM) - post-training(8 weeks)
- SATIS-Stroke - midterm(4 weeks)
- Grip Strength - midterm(4 weeks)
- Upper Extremity Functional Index (UEFI) - midterm(4 weeks)
- Upper Extremity Functional Index (UEFI) - followup(12 weeks)
- Stroke Impact Scale (SIS) - midterm(4 weeks)
- SATIS-Stroke- post-training(8 weeks)
- Jacket Test - midterm(4 weeks)
- Jacket Test - followup(12 weeks)
- Motor Activity Log (MAL) - post-training(8 weeks)
- - Motor Activity Log (MAL) - followup(12 weeks)
- Stroke Impact Scale (SIS) - post-training(8 weeks)
- Community Integration Questionnaire (CIM) - baseline(Baseline (0 week))
- Community Integration Questionnaire (CIM) - midterm(4 weeks)
- SATIS-Stroke - baseline(Baseline (0 week))
- Upper Extremity Functional Index (UEFI) - baseline(Baseline (0 week))
- Upper Extremity Functional Index (UEFI) - post-training(8 weeks)
- Community Integration Questionnaire (CIM) - followup(12 weeks)
- SATIS-Stroke - followup(12 weeks)
研究者
Shamay Ng
Professor
The Hong Kong Polytechnic University