The Therapeutic Effect of the Rehabotics Medical Technology Corporation (RMTC) Finger-hand Robot on Upper-limb Rehabilitation of Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change of Fugl-Meyer Assessment (FMA-Upper limb)
研究概览
简要总结
In the present study, the RMTC finger-hand robot and combined with the mechanism of neuroplasticity will be used on the upper-limb rehabilitation of stroke patients. The participants will be randomized assigned to treatment group (TG, robot assisted treatment) and control group (CG, conventional treatment). In the experimental group, task oriented bi-manual training will be applied using the unaffected hand to guide the affected hand by RMTC robot system. The investigators will estimate the motor function of distal part of upper-limb before and after treatments. The results will be compared with the convention rehabilitation treatment. The primary outcomes are Fugl-Meyer assessment (FMA); and the secondary outcome measurements are modified Ashworth scale (MAS),Action Reach Arm Test (ARAT), Box & block test、Brunnstrom recovery Stage, and motor activity log (MAL).
详细描述
Clinical reports indicated the functional recovery of the distal part of upper limb in stroke patient needs time period longer than other body parts, and there is a limitation in the efficiency of conventional treatment on the distal part of upper limb. Robot assisted rehabilitation is a novel application in treatment. Rehabilitation robot is able to assist patients move the affected side through external power to achieve a repeated exercising and further evoke the motor function. In the present study, the wearable RMTC finger-hand robot and combined with the mechanism of neuroplasticity will be used on the upper-limb rehabilitation of stroke patients. The patient (post stroke>1 month) age from 20-90 years old with Modified Ashworth Scale ≦2, Brunnstrom Recovery Stage of Arm ≧ 2, Mini-Mental State Examination ≧24 will be included as our participation. The participants will be randomized assigned to treatment group (TG, robot assisted treatment, n=30) and control group (CG, conventional treatment, n=30). In the treatment group, task oriented bi-manual training will be applied using the unaffected hand to guide the affected hand by RMTC robot system, the patient will also receive additional conventional treatment. In the control group, the patient will receive 100 minutes conventional treatment. The investigators will estimate the motor function of distal part of upper-limb before and after treatments. The results will be compared with the convention rehabilitation treatment. The primary outcomes are Fugl-Meyer assessment (FMA); and the secondary outcome measurements are modified Ashworth scale (MAS),Action Reach Arm Test (ARAT), Box & block test、Brunnstrom recovery Stage, and motor activity log (MAL). The investigators will follow up the patient at the 3rd and 6th month after complete trial.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Modified Ashworth Scale, MAS≦2
- •Brunnstrom Recovery Stage of Arm≧2
- •Mini-Mental State Examination; MMSE≧24
- •aged from 20-90 years
- •first stroke ≧1 month
排除标准
- •poor cognitive ability (such as moderate to severe dementia, etc.) or mental illness (such as convulsions)
- •wrist musculoskeletal system disease (such as fractures, tendon rupture, etc.) can not withstand external forces
- •skin disorders (such as pressure sores, trauma, cellulitis, etc.)
- •cerebellar stroke
结局指标
主要结局
Change of Fugl-Meyer Assessment (FMA-Upper limb)
时间窗: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Fugl-Meyer assessment is an stroke specific index for estimating the performance of motor function, Total scores of FMA-Upper limb ranged from 0-66.
次要结局
- Change of Action Research Arm Test (ARAT)(Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up))
- Change of Box & Block Test (BBT)(Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up))
- Change of Brunnstrom Recovery Stage (BRS)(Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up))
- Change of Modified Ashworth Scale (MAS)(Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up))
- Change of Motor Activity Log (MAL)(Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up))