Joint Gertner ReAbility Online and Mayo Clinic Feasibility Study: Evaluation of a Tele-Rehabilitation Service Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Satisfaction Questionnaire
研究概览
简要总结
Is a unique tele-rehabilitation service directed at treating upper limb weakness due to stroke feasible to provide at Mayo Clinic and are the individuals with stroke and the clinicians providing the care satisfied with the process?
详细描述
Participants will be identified from Mayo Clinic Division of Brain Rehabilitation's existing clinical practice and recruited either in person or by using a phone script.
Eligible participants will have 2 in-person clinical assessments, one before the intervention and one concluding the protocol. The first clinical assessment will involve introducing and familiarizing the participant with the study procedure, demonstrating and practicing with the system, and obtaining baseline clinical measures. During this first session the participant's technical skills and home equipment capabilities will be assessed and any assistance needed for establishing the technology in their home will be determined and provided. The second clinical assessment will include acquiring post-intervention clinical and outcome measures. Intervention duration will be 3 months. During the study period, each participant will receive online treatment for up to 45 minutes (in order to have net 30 min clinical time) twice per week. During these sessions, the clinician will teach system interaction including integrating feedback, instruct in system intervention activities and assure participant competence in system use, and adjust the level of difficulty in each activity according to the participant's abilities and needs. After the first month of intervention, the participant may be given permission by the therapist to train with the system for no more than 40 minutes per day. Such self-training opportunities are in addition to the twice weekly online sessions with the therapist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>12 months after stroke
- •Age 21-80 years
- •A minimum of 45 degrees of flexion in the affected shoulder
- •Active extension of the affected elbow to 150 degrees
- •Independent sitting balance
- •Able to understand simple instructions
- •Lives within a 100 mile radius and able to attend two clinical assessments at Mayo Clinic
- •Able to install the tele-rehabilitation software with minimal remote technical support
- •Available caregiver as needed who has basic technical understanding of computer operation
- •i3 processor based PC; 26" monitor; Windows 7 or 8 operating system; Internet connection of at least 10Mbps.
- •Medical conditions that may limit physical activity at the level of low intensity cardio-vascular exercise
- •Any contraindication related to the integrity of the musculoskeletal system
- •Active malignancy
- •Uncontrolled epilepsy
- •Global aphasia
- •Severe apraxia
- •Severe ataxia
- •Unilateral spatial neglect
- •Chronic pain
- •Pregnancy
- •Adults lacking capacity
排除标准
- 未提供
研究组 & 干预措施
Tele-motion rehabilitation system
Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles.
干预措施: Tele-motion rehabilitation system (Device)
结局指标
主要结局
Satisfaction Questionnaire
时间窗: 3 months
Clinician and participant satisfaction questionnaire
System Usability Scale
时间窗: 3 months
Clinician and participant usability questionnaire
Qualitative measure of technology/communications problems
时间窗: 3 months
Self report text of problems and difficulty with experimental technology and communication from participants and clinicians
次要结局
- Upper limb range of motion(Weekly through 3-month study period)
- Number of compensatory movements(Weekly through 3-month study period)
- Upper limb (shoulder, elbow) range of motion(Baseline and at 3 months)
- Fugl- Meyer Scale(Baseline and at 3 months)
- Motor Activity Log (MAL)(Baseline and at 3 months)
- Measures from the ReAbility Online system of participant and clinician activity(Weekly through 3-month study period)
- Task performance scores(Weekly through 3-month study period)
- Time online(Weekly through 3-month study period)