Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Changes From Baseline in Fugl-Meyer Upper Extremity Scores
研究概览
简要总结
The overall objective of the proposed study is to carry out usability and design-evaluation assessments of the BURT robotic device for delivering long-term intervention in stroke survivors. The BURT is an upper extremity robotic device that enables the user to see and feel engaging games that encourage intensive therapy. The investigators intend to recruit up to 10 stroke survivors over the course of the study. Participants will train their arm with the BURT for 18 sessions over approximately 6 weeks then participate in a question/answer formatted discussion with research staff to discuss the usability of the device. The investigators will also assess participant's arm function at baseline and after the training sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 and female, age 18-80;
- •Having had a stroke (ischemic or hemorrhagic) at least 6 months prior to study
- •Moderate to severe upper-limb motor impairments (score of 15-45 out of 66 on the Fugl- Meyer Scale);
- •Community dwelling;
- •Able to physically fit in the device.
排除标准
- •Current participation in rehabilitation program targeting upper extremity function;
- •Cognitive impairment resulting to inability to follow instructions or inability to sustain attention for more than 10 minutes;
- •Visual impairments not corrected with lenses (visual loss);
- •Aphasia sufficient to limit comprehension and completion of the treatment protocol;
- •No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;
- •Increased muscle tone (passive movement is difficult);
- •Previous diagnosis of neurological diseases other than stroke;
- •Other conditions affecting function of the stroke affected upper limb;
- •Individuals who present with the following: open wounds, fragile skin, active infection
结局指标
主要结局
Changes From Baseline in Fugl-Meyer Upper Extremity Scores
时间窗: 6 weeks
Assessment of upper extremity impairments. Individual items of the scale are summed for a total score ranking from 0 to 66. Higher scores indicate better outcomes.
次要结局
- Changes From Baseline in Goal Attainment Scale Scores(6 weeks)
研究者
Paolo Bonato
Principal Investigator, Director of the Motion Analysis Laboratory
Spaulding Rehabilitation Hospital