Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity; A Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Fugl-Meyer during washout
研究概览
简要总结
Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. The investigators are conducting a clinical study to test the efficacy of wrist-worn sensors that encourage affected limb use during activities of daily living.
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
- 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
- •Ischemic or hemorrhagic stroke at least 3 months prior to study enrollment
- •Mild-to-moderate to severe upper-limb motor impairments (as measured by a score between 21 and 50 on the arm section of the Fugl-Meyer scale).
排除标准
- •Cognitive impairments that would significantly interfere with their ability to follow instructions (as measured by a score lower than 23 on the Mini Mental State Examination scale)
- •Severe attention deficits or hemispatial neglect (as measured by the Mesulam Cancellation test and the Line Bisection test);
- •Severe range-of-motion limitations (as measured via physical examination) or severe spasticity (as measured using the Modified Ashworth scale) that would prevent safe performance of home-based exercises;
- •Proprioceptive deficits that impair their ability to process feedback (as measured using the Fugl-Meyer Assessment-upper extremity; sensory section).
- •Implantable medical devices that are not compliant with the ISO 14117:2012 and/or ANSI/AAMI PC69 standards for Bluetooth compatibility. We will ask subjects to provide us with their medical device record card and verify that the device complies with the above-mentioned standards. If not, they will be excluded from the study.
- •Participation in upper-extremity rehabilitation program (i.e. outpatient occupational therapy, research study, ...).
- •Recent (< 3 months) Botox injection in the upper-extremity or plan to undergo injections during the study timeline.
结局指标
主要结局
Change in Fugl-Meyer during washout
时间窗: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Fugl-Meyer Upper Extremity Assessment Scale score from end of intervention to follow-up (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).
Change in Motor Activity Log Quality Score during washout
时间窗: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Motor Activity Log Quality Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Change in Motor Activity Log Quantity Score during intervention
时间窗: 12 weeks
Change in Motor Activity Log Quantity Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Change in Fugl-Meyer during intervention
时间窗: 12 weeks
Change in Fugl-Meyer Upper Extremity Assessment Scale score from baseline (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).
Change in Motor Activity Log Quality Score during intervention
时间窗: 12 weeks
Change in Motor Activity Log Quality Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Change in Motor Activity Log Quantity Score during washout
时间窗: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Motor Activity Log Quantity Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
次要结局
- Change in Wolf Motor Function Test quality-subscale during intervention(12 weeks)
- Change in Wolf Motor Function Test time-subscale during washout(12 weeks (end of intervention), 20 weeks (follow-up))
- Change in Wolf Motor Function Test time-subscale during intervention(12 weeks)
- Change in Wolf Motor Function Test quality-subscale during washout(12 weeks (end of intervention), 20 weeks (follow-up))