The Effect of the Transcranial Direct Current Stimulation Combined Sensory Modulation Intervention on Upper Extremity Functional Rehabilitation in Patients With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change from baseline Active joint activity after intervention
研究概览
简要总结
Background and purpose:
About 30% of people with stroke suffered from severe long-term upper extremity （UE） motor impairment. Severe UE impairment, especially dysfunction of hand, can greatly impact stroke patients' daily living independence and quality of life. However, treatment effect of current interventions is still limited. Nick Ward and Leonardo Cohen suggested 5 intervention strategies for stroke motor recovery: （1） reduction of somatosensory input from the intact; （2） increase in somatosensory input from the paretic; （3） anesthesia of a body part proximal to the paretic hand; （4） activity within the affected motor cortex may be up-regulated; （5） activity within the intact motor cortex may be down-regulated. Recent studies have shown each strategy to be effective in stroke patients with mild or moderate UE impairment. However, evidence for people with severe UE impairment after stroke remains unclear. Since research has found a greater effect for combined strategies than a single strategy, this proposal develops a combined intervention with the above 5 strategies, named "transcranial direct current stimulation （tDCS） combined sensory modulation intervention". This intervention is expected to be most effective for people with severe UE impairment after stroke.
In addition, neuroimaging can provide in vivo information about the brain plasticity which underpinning the motor recovery after stroke. However, image indexes that can be used in stroke patients with severe UE impairment remained examined. Therefore, this proposal has 3 aims: （1） to examine the treatment effect of the "tDCS combined sensory modulation intervention" in stroke patients with severe UE impairment; （2） to examine the underline mechanism of the efficacy of "tDCS combined sensory modulation intervention" using neuroimaging technology.
Methods:
This study is a double-blinded randomized controlled trial which will recruit 60 people who have had stroke onset more than 6 months and have severe UE motor impairment. All participants will be randomly assigned into 2 groups. The experimental group will be given the "tDCS combined sensory modulation intervention", combining bilateral tDCS stimulation, anesthesia techniques and repetitive passive motor training. The control group is given sham tDCS, sham anesthesia and repetitive passive motor training. Each group will be evaluated for outcomes at 4 time points （i.e. baseline, post-intervention, 3 months and 6months post-intervention）. The immediate and long-term effect of the interventions will be examined.
Primary outcome indicators include upper extremity impairment measures. Secondary outcome measures include upper extremity function, activities of daily living function, functional Magnetic Resonance Imaging （fMRI）, and corticospinal tract structural integrity using diffusion spectrum imaging （DSI）. Fifteen subjects of each group will be assessed 2 times （i.e., prior to the intervention and after the intervention） for fMRI and DSI scan.
Anticipatory results and contributions:
The results of the studies are expected to present a potentially effective intervention for stroke patients with severe impaired UE motor. Imaging evidence of brain plasticity for this particular intervention is also provided. The results will contribute to our understanding of brain plasticity for UE motor recovery after stroke. Findings from this proposal may help researchers and clinicians choose or develop interventions that are optimal to their clients individually.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first ever ischemic or hemorrhagic stroke patients identified by computed tomography (CT) or magnetic resonance imaging (MRI)
- •age between 40 and 80 years old
- •have a stroke over 6 months
- •unilateral hemiplegia
- •Fugl-Meyer assessment-upper extremity (FMA-UE) score≦29 when selection
- •poststroke elbow flexor spasticity less than 2 using modified Ashworth scale (MAS)
- •no severe anesthesia (FMA sensory test, upper extremity score≧10 )
- •no wrist and finger joint pain
- •clear consciousness, can understand simple sentences and spoken orders, and co-operate manipulation
- •can accept motor training in the sitting position for approximately 30 minutes.
排除标准
- •Suffer from other orthopedic diseases (such as severe arthritis), nerve damage (such as peripheral nerve damage), or severe pain, which influences upper extremity motor
- •have a medical history or family history of epilepsy
- •regularly take central nervous system drugs (such as sedatives), or the Class III antiarrhythmic drugs (such as amiodarone)
- •have atopic dermatitis or skin disorders of the scalp
- •have allergy to anesthetic medicines of the acyl amine
- •have a metal implant in the head or neck, or serious arrhythmia (the heartbeat is less than 50 beats per minute or higher than 100 beats per minute); or use a pacemaker or atrial defibrillator
- •suffer from congenital or idiopathic methemoglobinemia. Aphasia is not an exclusion criterion, but the patients should understand simple spoken orders.
研究组 & 干预措施
tDCS & epidermis anesthesia & repeated passive movement
The patients in the experiment group will receive multi-strategy combination treatment mode- "combined tDCS and sensory input regulation treatment mode", including bilateral tDCS , epidermis anesthesia in the proximal hand of affected side and in the distal hand of unaffected side , and repeated passive movement training for the hand of affected side.
Treatment modes are 3 times a week, 30 minutes each time, lasting for 8 weeks, and totally 24 trainings. The treatment content of each strategy is separately described in the following.
干预措施: tDCS (Device)
tDCS & epidermis anesthesia & repeated passive movement
The patients in the experiment group will receive multi-strategy combination treatment mode- "combined tDCS and sensory input regulation treatment mode", including bilateral tDCS , epidermis anesthesia in the proximal hand of affected side and in the distal hand of unaffected side , and repeated passive movement training for the hand of affected side.
Treatment modes are 3 times a week, 30 minutes each time, lasting for 8 weeks, and totally 24 trainings. The treatment content of each strategy is separately described in the following.
干预措施: Epidermis anesthesia (Drug)
tDCS & epidermis anesthesia & repeated passive movement
The patients in the experiment group will receive multi-strategy combination treatment mode- "combined tDCS and sensory input regulation treatment mode", including bilateral tDCS , epidermis anesthesia in the proximal hand of affected side and in the distal hand of unaffected side , and repeated passive movement training for the hand of affected side.
Treatment modes are 3 times a week, 30 minutes each time, lasting for 8 weeks, and totally 24 trainings. The treatment content of each strategy is separately described in the following.
干预措施: Repeated passive movement (Other)
Shame tDCS & sham anesthesia & repeated passive movement
the control group is "repeated passive movement stimulation", including sham bilateral tDCS, sham epidermis anesthesia in the proximal hand of affected side and in the distal hand of unaffected side, and repeated passive movement training for the hand of affected side.
Treatment modes are 3 times a week, 30 minutes each time, lasting for 8 weeks, and totally 24 trainings. The treatment content of each strategy is separately described in the following.
干预措施: sham anesthesia (Drug)
Shame tDCS & sham anesthesia & repeated passive movement
the control group is "repeated passive movement stimulation", including sham bilateral tDCS, sham epidermis anesthesia in the proximal hand of affected side and in the distal hand of unaffected side, and repeated passive movement training for the hand of affected side.
Treatment modes are 3 times a week, 30 minutes each time, lasting for 8 weeks, and totally 24 trainings. The treatment content of each strategy is separately described in the following.
干预措施: Repeated passive movement (Other)
Shame tDCS & sham anesthesia & repeated passive movement
the control group is "repeated passive movement stimulation", including sham bilateral tDCS, sham epidermis anesthesia in the proximal hand of affected side and in the distal hand of unaffected side, and repeated passive movement training for the hand of affected side.
Treatment modes are 3 times a week, 30 minutes each time, lasting for 8 weeks, and totally 24 trainings. The treatment content of each strategy is separately described in the following.
干预措施: sham tDCS (Device)
结局指标
主要结局
Change from baseline Active joint activity after intervention
时间窗: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
A protractor is used to estimate 4 active joint activities of patients,including wrist extension, carpometacarpal extension, metacarpophalangeal extension, and shoulder flexion.
Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale after intervention
时间窗: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
FMA-UE estimates the movement of proximal upper extremity (including shoulder joint, elbow joint and forearm), wrist joint and hand. Each movement is estimated by 3 scaled rules (0-1-2): score 0 indicates that the patient has no movement at all; score 1 indicates that the patient can perform partial movements; score 2 indicates that the patient can normally perform all movements. The total score in the differential scale is 66, and a higher score indicates that the patient has better movement ability.
Change from baseline Muscle tone after intervention
时间窗: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Motor assessment scale (MAS) is used to estimate muscle tension in patients, and the estimated muscles include the flexors and extensors of elbow, wrist and metacarpophalangeal joints. MAS is totally divided into 6 scales (0, 1, 1+, 2, 3, 4), and a higher score indicates that the patient has higher muscle tension.
次要结局
- Change from baseline research arm test (ARAT) after intervention(Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section))
- Change from baseline Diffusion Spectrum Imaging after intervention(Assessed at the baseline section (within 7 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 7 days after the latest intervention section).)
- Change from baseline Patient Health Questionnaire (PHQ-9) at 3 months after intervention(Assessed at 3 months after intervention)
- Change from baseline Patient Health Questionnaire (PHQ-9) at 6 months after intervention(Assessed at 6 months after intervention)
- Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale at 6 months after intervention(Assessed at 6 months after intervention)
- Change from baseline Active joint activity at 6 months after intervention(Assessed at 6 months after intervention)
- Change from baseline Barthel Index(BI) after intervention(Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section))
- Change from baseline Patient Health Questionnaire (PHQ-9) after intervention(Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section))
- Change from baseline research arm test (ARAT) at 3 months after intervention(Assessed at 3 months after intervention)
- Change from baseline fMRI activation after intervention(Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section))
- Change from baseline research arm test (ARAT) at 6 months after intervention(Assessed at 6 months after intervention)
- Change from baseline Barthel Index(BI) at 3 months after intervention(Assessed at 3 months after intervention)
- Change from baseline Barthel Index(BI) at 6 months after intervention(Assessed at 6 months after intervention)
- Change from baseline Active joint activity at 3 months after intervention(Assessed at 3 months after intervention)
- Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale at 3 months after intervention(Assessed at 3 months after intervention)
- Change from baseline Muscle tone at 3 months after intervention(Assessed at 3 months after intervention)
- Change from baseline Muscle tone at 6 months after intervention(Assessed at 6 months after intervention)