The Mobility Toolkit: Electronically Augmented Assessment of Functional Recovery Following Lower-extremity Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 10
- 主要终点
- Number of patient complications resulting from injury
研究概览
简要总结
The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus.
详细描述
The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus. All participating centers will undergo training to implement the Mobility Toolkit (MTK). Research Staff will facilitate a series of performance tests while participants wear the MTK device. MTK assessment will also be conducted on 150 non-injured adults matched to the injured cohort on age and gender. These individuals will be enrolled and assessed once at two participating centers. Study flow and data capture are summarized in the figure on the next page.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age
- •Open or closed fractures of the tibial plateau, pilon, ankle or calcaneus requiring surgical fixation.
排除标准
- •Gustilo type IIIB or IIIC injuries
- •No other surgically or non-surgically treated injuries that impact gait (e.g. upper extremity injury proximal to the elbow; spinal cord injury; contralateral or ipsilateral fractures).
- •Neurologic impairment or deficit that impairs gait
- •Prior injuries or conditions that alter gait (e.g. severe osteoarthritis)
- •Severe problems with maintaining follow-up (e.g. participants who are prisoners, who are intellectually challenged without adequate family support, or have documented psychiatric disorders).
- •Unable to provide informed consent in English or Spanish.
结局指标
主要结局
Number of patient complications resulting from injury
时间窗: 12 months
Injury related complications such as infection, non-union, and hardware failure will be captured prospectively the year following treatment.
Gait Quality assessed with Mobility Tooklkit
时间窗: 12 months
Gait Quality will be measured using the MTK to assess gait parameters such as lift acceleration, step time asymmetry, and peak-to-peak upper body pitch and roll.
Ease of use of the Mobility Toolkit during clinic
时间窗: 12 months
Feasibility will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.
Satisfaction of the Mobility Toolkit
时间窗: 12 months
Satisfaction will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.
Gait Quality assessed by performance tests
时间窗: Change in gate from measured at 3, 6 & 12 months
Gait will be assessed while completing three performance tests: 10 meter walk, sit to stand, and timed up and go (TUG) Injured participants will be assessed at time of first weight bearing, and at clinic visits 3, 6 and 12 months following definitive treatment.
Physical Function
时间窗: Change in physical function measured at 3, 6, & 12 months
Patient Reported Function will be assessed using the physical function item banks from the Patient Reported Outcomes Measurement Information System (PROMIS). Injured participants will be assessed at baseline and at each follow-up visit.
Pain Score
时间窗: Change in pain score measured at 3, 6, & 12 months
Patient Reported Pain will be assessed using the pain interference item banks from the Patient Reported Outcomes Measurement Information System (PROMIS). Injured participants will be assessed at baseline and at each follow-up visit.
次要结局
未报告次要终点