Effects of Upper Limb Motor Training and Upper Limb Robotic Training Over Neuroplasticity and Function Capacity: A Single-blind Randomized Clinical Trial With Patients With Stroke Sequelae
试验速览
- 阶段
- 2 期
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change on Motor Function assessed by Wolf Motor Function scale
研究概览
简要总结
The purpose of this study is to evaluate and compare the effects of upper limb training with Induced Constraint Therapy (ICT) or robotic therapy. No placebo therapy is used. Motor function, neurological evaluations and quality of life are assessed for the comparison of the therapies.
详细描述
The trial is being carried out in the Institute of Physical Medicine and Rehabilitation of the University of São Paulo since February 2012. The investigators are including patients with clinical diagnosis of Ischemic or hemorrhagic stroke.
The patients are being randomized in blocks of four, six and eight, in two arms: ICT: patients are undergoing 60 minutes physiotherapy and occupational therapy twice a week for ten consecutive weeks. Other therapeutic services as phonoaudiology, psychology, nutrition, physical conditioning are prescribed upon the patients' medical demands. After the 10 weeks, the patients are undergoing two whole weeks of daily ICT as to reach 90% of the time under constraint, including weekends. During this last period, no other therapeutic service is offered, but the occupational therapy under ICT. Patients are not allowed to undergo robotic therapy.
Robotic therapy: patients are undergoing robotic occupational therapy for 60 minutes, three times a week for twelve consecutive weeks. All other therapeutic services are prescribed upon the patients' medical demands. Patients are not allowed to undergo ICT.
The investigator and the raters are blind to treatment.
The evaluations are done prior to the beginning of the treatment and at the end of it. The follow up assessments are done at 3 and 12 months after the end of the treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of stroke;
- •Patients from 6 months after stroke up to 36 months after stroke;
- •Clinically stable;
- •Upper limb Brunnstrom scale III or IV;
- •Brunnstrom scale above V if clinician supports patients will benefit from treatment;
- •Minimum wrist extension of 20°, and minimum of 10° of metacarpophalangeal active extension.
- •Signed Informed Consent Form;
排除标准
- •Mini-Mental score lower than 20 points;
- •Previous multiple strokes;
- •Bone diseases and articulation injuries ;
- •Presence of psychological disturbances capable of diminishing adherence;
- •Articulation pain within the range of motion proposed by the therapies;
- •Participation in another study protocol for upper limbs therapies.
- •Previous treatment with robotic assisted therapies.
研究组 & 干预措施
Induced Constraint Therapy - ICT
Physical rehabilitation with Induced Constraint Therapy as part of the occupational therapy. Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.
干预措施: Induced Constraint Therapy - ICT (Procedure)
Robotic occupational therapy
Physical rehabilitation with Robotic occupational therapy. Robotic Occupational Therapy three times a week for twelve weeks.
干预措施: Robotic occupational therapy (Procedure)
结局指标
主要结局
Change on Motor Function assessed by Wolf Motor Function scale
时间窗: Baseline and 12 weeks
Change from baseline in Wolf Motor Function scale.
Change on Motor Function assessed by Fugl Meyer scale
时间窗: Baseline and 12 weeks
Change from baseline in Fugl Meyer scale.
次要结局
- Change on Motor Function assessed by Wolf Motor Function scale(Baseline, 3 months and 12 months)
- Change on Motor Function assessed by Fugl Meyer scale(Baseline, 3 months and 12 months)
- Change on Motor Function assessed by Robotic scale(Baseline, 3 months and 12 months)
- Change on Function ability and quality of movement assessed by Arm Motor Ability Test (AMAT)(Baseline, 12 weeks, 3 months and 12 months)
- Change on Functional Independence Measure (FIM) as assessed by FIM scale(Baseline, 12 weeks, 3 months and 12 months)
- Change on Quality of life assessed by Stroke Impact Scale (SIS)(Baseline, 12 weeks, 3 months and 12 months)
- Change on Kinematic variables assessed by InMotion robots(Baseline, 12 weeks, 3 months and 12 months)