BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors: a Comparison of Unimanual vs. Unimanual and Bimanual Tasks During Robot-assisted Arm Training
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 主要终点
- Motor Activity Log- Amount of Use
研究概览
简要总结
The focus of this study is to perform a preliminary assessment of the efficacy of the BurtVision system. While the Burt robotic-arm assists the patient's upper-limb in their movements, BurtVision will allow the patient to perform unimanual and bimanual activities while leveraging augmented reality games. The investigators will compare clinical outcomes when the BurtVisions ystem is used for training solely relying on unimanual tasks vs. when it is used for training relying on both unimanual and bimanual tasks.
详细描述
The proposed study is a single-blinded randomized clinical trial to evaluate the effect of using the BurtVistion on motor gains after robot-assisted upper-limb. Study participants (stroke survivors) will be recruited at the Spaulding Rehabilitation Hospital - Boston. Subjects will be randomly assigned to one of the two different groups: unimanual or unimanual + bimanual arm therapy using a block-randomized allocation procedure to ensure important covariates, such as baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores and chronicity, are balanced between groups.
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 (Outcomes Assessor)
盲法说明
Outcome assessor will be blinded to the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-80 years old;
- •Unilateral ischemic or hemorrhagic stroke at least 6 months and no more than 5 years prior to study enrollment;
- •Upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 12 and 40;
- •Some active pro-supination range of motion;
- •Some active metacarpal-phalangeal joint in the hemiparetic hand;
- •Intact cognitive function to understand the robotic therapy procedures (MMSE>23 and able to follow 3 step command) during initial evaluation visit;
排除标准
- •Undergoing upper-limb rehabilitation therapy during the period of the study.
- •Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe use of the robotic system;
- •Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject's ability to play the interactive games (as assessed with the line bisection test);
- •Severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening;
- •Communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record);
- •Individuals with open wounds or recent fracture (<3 months) in the upper extremity, fragile skin or active infection;
- •Upper-extremity orthopedic injuries or severe pain resulting in movement limitations.
结局指标
主要结局
Motor Activity Log- Amount of Use
时间窗: Data will be collected at baseline and at 7-8 weeks
Self-reported measures of upper extremity activity performance in daily life (amount of use)
次要结局
- Wolf Motor Function Test(Data will be collected at baseline and at 7-8 weeks)
- Fugl-Meyer Assessment, Upper-Extremity portion(Data will be collected at baseline and at 7-8 weeks)
- Stroke Impact Scale(Data will be collected at baseline and at 7-8 weeks)
- Upper-Extremity Accelerometry(Data will be collected at baseline and at 7-8 weeks)
- Motor Activity Log- Quality of Use(Data will be collected at baseline and at 7-8 weeks)
研究者
Paolo Bonato
Associate Professor, HMS and Director, Motion Analysis Laboratory
Spaulding Rehabilitation Hospital