Evaluation of a Tele-Rehabilitation Service Program
Joint Gertner ReAbility Online and Mayo Clinic Feasibility Study: Evaluation of a Tele-Rehabilitation Service Program
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion
- >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.
Exclusion
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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Tele-motion rehabilitation system: Interventions include functional therapeutic exercise and real-time feedback.
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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Satisfaction Questionnaire
大体时间：3 months
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Clinician and participant satisfaction questionnaire
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3 months
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System Usability Scale
大体时间：3 months
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Clinician and participant usability questionnaire
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3 months
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Qualitative measure of technology/communications problems
大体时间：3 months
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Self report text of problems and difficulty with experimental technology and communication from participants and clinicians
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Upper limb (shoulder, elbow) range of motion
大体时间：Baseline and at 3 months
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Upper limb (shoulder, elbow) range of motion of the participant as measured by a goniometer
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Baseline and at 3 months
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Fugl- Meyer Scale
大体时间：Baseline and at 3 months
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Fugl- Meyer Assessment for the participant's upper limb
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Baseline and at 3 months
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Motor Activity Log (MAL)
大体时间：Baseline and at 3 months
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Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 30 daily functional tasks (original MAL), 28 functional tasks (MAL 28) or 14 tasks (MAL 14).
Target tasks include object manipulation (e.g.
pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g.
transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting).
Items scored on a 6-point ordinal scale.
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Baseline and at 3 months
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Measures from the ReAbility Online system of participant and clinician activity
大体时间：Weekly through 3-month study period
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Time of practice by participant as measured by the ReAbility Online system
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Weekly through 3-month study period
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Task performance scores
大体时间：Weekly through 3-month study period
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Participant task performance scores as measured by the ReAbility Online system
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Weekly through 3-month study period
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Upper limb range of motion
大体时间：Weekly through 3-month study period
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Upper limb range of motion of participant as measured by the ReAbility Online system
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Weekly through 3-month study period
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Number of compensatory movements
大体时间：Weekly through 3-month study period
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Number of compensatory movements as measured by the ReAbility Online system
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Weekly through 3-month study period
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Time online
大体时间：Weekly through 3-month study period
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Time online of participant and clinician as measured by the ReAbility Online system
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Weekly through 3-month study period
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Tele-motion rehabilitation system的临床试验
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IRCCS Eugenio Medea招聘中