NCT02958553已完成不适用
EmPOWERing Active Seniors With Energy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Participants With Improvement, No Change, or Worsening in Performance in the Six Minute Walk Test (6MWT)
研究概览
简要总结
A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.
详细描述
The primary objective of this study is to characterize the increase in the distance subjects can walk during a six (6) minute period while wearing the emPOWER Ankle compared to a passive lower-extremity prosthesis.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •55 years or older
- •Subjects with transtibial amputations of either leg at least 1 year prior
- •Suction or elevated vacuum suspension and Socket Comfort Score of at least 6
- •Sock fluctuation of ≤ 8 ply per day
- •K-level rating of 3 or 4 based on the Amputee Mobility Predictor Assessment Tool
- •Ability to walk at a walking speed of > 0.75 meters per second
- •Unilateral amputees (up to 7 bilateral amputees can be included, 1 per site in addition to the unilateral amputees who will be analyzed as a separate sub group)
- •Foot size: 25-30 cm
- •Ability to complete a continuous 6-Minute Walk Test
- •Ability to provide written, informed consent
- •Ability to complete study visits and study documents
- •Ability to manage the complexity of a powered device including charging and changing batteries as needed
- •Ability to read and understand English
排除标准
- •Subjects who have never used a prosthetic device
- •Less than 55 years of age
- •Weight <150 lbs. or > 287 lbs.
- •Transfemoral amputees
- •Active sores or ulceration on subject's residual limb
- •Sore on contralateral foot.
- •Cuff-link socket suspension
- •Socket Comfort Score less than 6
- •Sock fluctuation of > 8 per day
- •K level of 1 or 2
- •Amputation clearance < 8.625"
- •History of stroke or TIA that impairs current walking
- •Recent history of excessive falling defined as more than 2 falls requiring medical assistance in the prior year
- •Medications potentially affecting balance
- •Recent hospitalization (within past 3 months)
- •Cognitive deficiency that would impact ability to charge and change batteries as needed
结局指标
主要结局
Number of Participants With Improvement, No Change, or Worsening in Performance in the Six Minute Walk Test (6MWT)
时间窗: 3 months with the emPOWER ankle
The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking distance measured by the Six Minute Walk Test (6MWT). 6minWT improvement was defined as a minimum increase of 45 meters.
次要结局
- Number of Participants With Improvement, No Change, or Worsening in Performance in the Twelve Minute Walk Test (12MWT)(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in the 10 Meter Walk Test (10MWT)(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in the L-Test(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in the Ramp Test(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in the Activities-specific Balance Confidence (ABC) Scale Score(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in the Falls Efficacy Scale Score(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in the Amputee Mobility Predictor (AMP) Assessment(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in the Prosthetic Limb Users Survey of Mobility PLUS-M (12 Item Short Form)(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in the Patient Specific Functional Scale (PSFS)(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in the Numeric Pain Rating Scale (NPRS)(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in Activity (Monitoring Using a Fitbit Over 2-week Periods)(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Physical Function(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Global Health Short Form(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Fatigue Short Form (7a)(3 months with the emPOWER ankle)
- Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Pain Intensity Short Form (3a)(3 months with the emPOWER ankle)
研究者
研究点 (2)
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