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临床试验/NCT03107728
NCT03107728Unknown不适用

The IM ABLE Study: A Cross-Sector, Multisite Initiative to Advance Care for Warriors and Veterans Following Neuromusculoskeletal Injury of the Lower Limb

University of South Florida3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
3
主要终点
Change in Mobility

研究概览

简要总结

The purpose of the IM ABLE(Injuries Managed with Advanced Bracing for Lower Extremities) study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.

详细描述

There were approximately 20,000 extremity trauma cases associated with the wars in Iraq and Afghanistan. Many of these individuals have experienced multiple limb-sparing surgeries and orthotic utilization. Many continue functioning with use of their orthosis while others may seek delayed amputation. It is unclear if limb salvage or amputation is more advantageous functionally or preferred following lower extremity(LE) trauma. The IDEO (Intrepid Dynamic Exoskeletal Orthosis) was developed to assist in maintaining high functional performance in patients who have experienced high energy lower extremity trauma (HELET) and limb salvage surgeries primarily effecting the LE below the level of the knee joint. The IDEO represents one "advanced" orthotic option for a traumatized and surgically spared limb however there are other "advanced" orthotic options. Problematically, few studies have reported outcomes associated with these devices. In the few studies available, sample sizes are small which greatly reduces generalizability of study findings. The purpose of the IM ABLE study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lower extremity injury of any etiology requiring use of an AFO
  • Male or Female, of any ethnicity
  • 18-65 yrs of age
  • 100-275 lbs
  • ≥ 1 yr. of orthotic experience

排除标准

  • Body weight <100 or >275 lbs
  • Does not speak English or Spanish
  • Known cognitive impairment (i.e. Diagnoses such as Traumatic Brain Injury, Dementia)

研究组 & 干预措施

Conventional orthotic brace

Active Comparator

干预措施: Conventional orthotic brace (Device)

Advanced orthotic brace

Experimental

干预措施: Advanced orthotic brace (Device)

结局指标

主要结局

Change in Mobility

时间窗: Mobility will be assessed at Week 2 and Week 4

Mobility will be assessed with the Timed Up \& Go test. subjects are timed while they rise from a chair, walk 3m, turn around, return to the chair and sit down again. Patients are usually permitted to use a walking aid, but not to use physical assistance.

Change in Ambulatory Function

时间窗: Ambulatory Function will be assessed at week 2 and week 4.

The 2 Minute Walk Test will be used to assess ambulatory function

次要结局

  • Perceived Function(At week 2 and week 4)
  • Pain(At week 2 and week 4)
  • Safety will be measured with the Activities Balance Confidence Scale(At week 2 and week 4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Highsmith

Associate Professor

University of South Florida

研究点 (3)

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