Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Box and Block Test; Data Collected = Number of Blocks Moved
研究概览
简要总结
The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.
详细描述
Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity: 90 minutes/session, 2 sessions/week 2 weeks; bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers; (b) high intensity: 90 minutes/session, 4 sessions/week for 2 weeks; bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors; and (c) control group (sham active stimulation). Patients' UE motor capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest).
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)
入排标准
- 年龄范围
- 44 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an ability to complete 10º of wrist or finger extension from a 60 - 65 º flexed position
- •score less than a 56 on the UE subscale of the Fugl-Meyer Assessment
- •an ability to voluntarily activate slight movements in the wrist and fingers so that the EMG activity reaches a minimal level on the microprocessor for electrical stimulation to be activated
- •unilateral, first stroke of ischemic or hemorrhagic origin in the carotid artery distribution
- •free of major post stroke complications
- •able to attend therapy 2 days/week or 4 days/week for 2 weeks
- •score at least a 16 on the Mini Mental Status Examination
- •able to discriminate sharp from dull and light touch using traditional sensation tests.
排除标准
- •hemiparetic arm is insensate
- •motor impairments from stroke on opposite side of body
- •pre-existing neurological disorders such as Parkinson's disease, Multiple Sclerosis, or dementia
- •Legal blindness or severe visual impairment; 5) Life expectancy less than one year
- •Severe arthritis or orthopedic problems that limit passive ranges of motion of upper extremity (passive finger extension < 40º; passive wrist extension < 40º; passive elbow extension <40º; shoulder flexion/abduction < 80º)
- •History of sustained alcoholism or drug abuse in the last six months
- •Has pacemaker or other implanted device
结局指标
主要结局
Box and Block Test; Data Collected = Number of Blocks Moved
时间窗: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1" x 1" block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box.
Fugl-Meyer Upper Extremity Motor Test
时间窗: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.
Fractionated Reaction Time
时间窗: Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)
Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.
次要结局
未报告次要终点