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临床试验/NCT03416842
NCT03416842已完成1 期

Home-based Exercises Using Wearable Motion Sensors for Community-dwelling Stroke Survivors With Hemiparesis

Burke Medical Research Institute2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年2月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
6
试验地点
2
主要终点
Number of treatment days completed

研究概览

简要总结

Repetitious motor therapy has been shown to yield the greatest improvement in motor function in those who suffer hemiplegia because of a neurological impairment. However, motor therapy remains largely clinically based due to the absence of quantitative home-based therapy technology or equipment. With the current lack of accountability, patient adherence to home exercise physical therapy programs is estimated to be as low as 35%. In response, some companies have extended the applications of their motion capture devices to be used for home-based physical therapy. However, the technologies often have not passed their initial stages of development. In contrast, a company named 4D Motion is actively working alongside the Restorative Neurology Clinic at Burke Medical Research Institute to develop a motion capture system tailored to the motor rehabilitation of hemiplegic stroke patients. This device is driven by a user's active range of motion and does not impart electrical or mechanical stimulation to the user. The device does not force the user beyond their active range of motion and does not apply resistance to motion that limits the user's capability. The 4D Motion capture system is only used to record what the patient is doing and to promote adherence to their prescribed physical therapy plan.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to follow 1-2 step commands
  • Neurological deficit leading to hemiparesis or hemiplegia with a sensorimotor deficit
  • Fugl Meyer Upper Extremity Score of at least 20/66

排除标准

  • Has a metal implant anywhere on or inside the body
  • Fixed contracture or deformity of affected upper extremity
  • Individuals with bilateral stroke (i.e. if both arms are affected)
  • Unable to tolerate repetitious movement as determined by Likert Scale Rating greater than 5 out of 10

研究组 & 干预措施

Training with 4D Motion Capture Device

Experimental

Participants will be given access to a tablet-based application and non-invasive sensors that will track movements of the upper extremity and will prompt daily exercise. Participants will be encouraged to use the device daily for 30 consecutive days, up to one hour per day.

干预措施: Training with 4D Motion Capture Device (Device)

结局指标

主要结局

Number of treatment days completed

时间窗: From day 1 to day 30 of intervention

Measure of the number of days that the participant adheres to the prescribed therapy plan (completion of 1000 movements). Goal is to have participants perform 1000 movements per day over 30 days.

Change in active range of motion of shoulder, elbow, and wrist

时间窗: From day 1 to day 30 of intervention

Maximum angular position about a joint that the participant can reach without assistance.

次要结局

  • System usability survey(Day 30 of intervention)
  • Physical Activity Enjoyment Scale(Day 30 of intervention)
  • Change in Fugl Meyer upper extremity assessment(From day 1 to day 30 of intervention)

研究者

发起方
Burke Medical Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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