A Randomized, Controlled Clinical Trial of Upper Limb Training With Bilateral Cutaneous Electrical Stimulation to Improve Upper Limb Functions in Patients With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Fugl Meyer Assessment on Upper Extremity (FMA-UE)
研究概览
简要总结
On the basis that the combined use of Uni-TENS and TRT is an effective intervention in upper limb recovery, and the advantage of Bi-TENS eliciting extra neural pathway in the intact hemisphere to facilitate the motor recovery, There is a research gap in whether the Bi-TENS over both the paretic and non-paretic limbs could probably augment the treatment effects of TOT in upper limb motor control in people with stroke.
详细描述
The purpose of this study is to determine whether Bi-TENS+TOT was superior to Uni-TENS+TOT, Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor control and upper limb function and community integration in people with chronic stroke.
The null hypothesis will be that Bi-TENS+TOT is not significantly different from Uni-TENS+TOT,Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor control and upper limb function and community integration in people with chronic 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
- Double (Participant, Outcomes Assessor)
盲法说明
The participant and outcome assessor were blinded to the group allocation
入排标准
- 年龄范围
- 50 Years 至 80 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 are between 50 and 80 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
- •have volitional control of the non-paretic arm and at least minimal antigravity movement in the shoulder of the paretic arm,
- •have at least 5º in wrist extension in the antigravity position,
- •score > 6 out of 10 in the Abbreviated Mental Test, and
- •are able to follow instructions and give informed consent.
排除标准
- •• have any additional medical, cardiovascular or orthopedic condition
- •use a cardiac pacemaker
- •have receptive dysphasia
- •have a significant upper limb peripheral neuropathy
- •are involved in drug studies or other clinical trials, or
- •have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm, and
- •have a skin allergy that would prevent electrical stimulation.
研究组 & 干预措施
Bilateral TENS (Bi-TENS) group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation
干预措施: Task-orientated training (Behavioral)
Bilateral TENS (Bi-TENS) group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Device)
Unilateral TENS (uni-TENS) group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side and sham electrical stimulation on the non-paretic side
干预措施: Task-orientated training (Behavioral)
Unilateral TENS (uni-TENS) group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side and sham electrical stimulation on the non-paretic side
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Device)
Unilateral TENS (uni-TENS) group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side and sham electrical stimulation on the non-paretic side
干预措施: Sham electrical nerve stimulation (Device)
Placebo group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation
干预措施: Task-orientated training (Behavioral)
Placebo group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation
干预措施: Sham electrical nerve stimulation (Device)
Control group
No Active intervention
结局指标
主要结局
Fugl Meyer Assessment on Upper Extremity (FMA-UE)
时间窗: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
FMA-UE was used for evaluating the upper limb motor control from proximal to distal part of the limb, and voluntary movement from synergistic to isolated in people with stroke. The FMA-UE has shoulder-arm, wrist, hand and coordination and speed subsections. The score of shoulder-arm, wrist, hand and coordination and speed sub-scale are combined to compute the total score. The maximum total score is 66, with 33 items and ordinal scoring from 0 to 2. A higher score of FMA-UE indicated a higher level of upper limb motor control.
次要结局
- Action Research Arm Test (ARAT)(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))
- Motor Activity Log (MAL)(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))
- Chinese Version of Community Integration Measure (CIM)(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))
- Jacket Test (JT)(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))
- Maximal Voluntary Contraction (MVC)-Peak Torque(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))
- The Range of Motion (ROM) of Upper Limb Joints(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))
- Maximal Voluntary Contraction (MVC)-Cocontraction Ratio(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))
研究者
Shamay Ng
Associate Professor
The Hong Kong Polytechnic University