The IM ABLE 2 Study: Long Term Outcomes to Advance Care for Warriors and Veterans Using Advanced Ankle Foot Orthoses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Timed Up & Go
研究概览
简要总结
The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function.
详细描述
The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function. Some lower limb AFO users will decide later to amputate the affected limb to escape pain and repeated surgery requiring them to use a prosthesis instead. Benefits may include reduced pain and more function from a prosthesis.
This research will allow physicians, physical therapists, orthotists, and researchers to determine what modifications can be made to AFOs to make them more comfortable and usable. Over the course of a year, subjects will test both AFO types; a conventional (standard) AFO and an advanced (energy storing and return) AFO, in a battery of physical tests, community use, and surveys to gain a better understanding of the pros and cons of each.
Subjects will be recruited to participate in research for approximately 18 months. During the first six weeks (up to three weeks on each type of AFO), subjects will be provided with an AFO and given training on how to correctly use and maintain it, to ensure optimal use. Over the following 12 months, there will be monthly assessments including questionnaires, activity monitor uploads, device failures, and interviews to gather information on the subject's experience with AFO use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower extremity injury of any etiology requiring current use of an AFO
- •Age 18-80 years
- •100-275 lbs
- •Greater than 1 month of AFO experience
- •Use of an AFO for activities of daily living
- •English or Spanish speaking
- •Able to comply with study procedures
排除标准
- •Body mass less than 100 or greater than 275 lbs.
- •Over 80 years of age
- •Known cognitive impairment (e.g. diagnoses such as moderate/severe traumatic brain injury, dementia)
- •Inability to comply with instructions.
- •Pregnancy
- •Medical conditions that would preclude safe involvement
- •Unable to provide written informed consent.
研究组 & 干预措施
Conventional Ankle Foot Orthosis (AFO)
Limited function; thermoplastic or thermoset material
干预措施: Conventional Ankle Foot Orthosis (AFO) (Device)
Advanced Ankle Foot Orthosis (AFO)
Return stored energy; laminated; may include posterior struts; higher activity
干预措施: Advanced Ankle Foot Orthosis (AFO) (Device)
结局指标
主要结局
Timed Up & Go
时间窗: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
The Timed Up\& Go (TUG) assesses mobility. In this test, subjects are timed while they rise from a chair, walk 3m, turn around, return to the chair and sit down again. Subjects are usually permitted to use a walking aid, but not to use physical assistance.
Two-minute Walk Test
时间窗: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
The Two-minute Walk Test (2MWT) assesses walking ability. Subjects will be asked to walk the greatest distance they can in 2 minutes while walking a 15.2m 'out and back' course until asked to stop. The distance walked will be recorded as will the post-test rate of perceived exertion (6-20 Borg RPE scale).
Four-Square-Step-Test
时间窗: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
The Four-Square-Step-Test is a balance and agility test where the patient changes direction quickly while maintaining balance. A 1-inch-high obstacle in the shape of a Maltese cross is placed on the floor. The patient is instructed to begin in the back, left quadrant then to move 1) forward, 2) sideways right, 3) backward, then 4) sideways left, then to move in the reverse direction back to the original square. They move as fast as possible through their movement progression while always keeping one foot on the floor.
Activities-Specific Balance Confidence Scale
时间窗: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
The Activities-Specific Balance Confidence Scale (ABC Scale) is a 16-item self-report tool that measures an individual's confidence in performing daily activities without losing balance or feeling unsteady. Participants rate their confidence for each activity on a 0% to 100% scale where 0% indicates no confidence and 100% indicates complete confidence.
Patient-Reported Outcomes Measurement Information System (PROMIS)
时间窗: After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PROMIS-PI) is a standardized, self-reported tool designed to assess the extent to which pain disrupts a person's daily activities and quality of life. The PROMIS-PI evaluates the impact of pain on social, physical, emotional and cognitive functioning. Responses are rated on a 5-point scale from "never" to "very much" regarding how pain interfered with activities in the past week.
Orthotics and Prosthetics Users' Survey (OPUS)
时间窗: After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B.
The OPUS is a self-report questionnaire consisting of five modules. The following four modules related to the lower extremity will be used: 1) Lower Extremity Functional Status Measure, 2) Health Related Quality of Life Index, 3) Satisfaction with Devices and 4) Satisfaction with Services. The first two modules are based on a five-point Likert scale and nominal Yes/No scale while the latter two use a four-point Likert scale. Higher scores indicate better outcomes.
次要结局
- Preference(Before and after each accommodation and training period. At 12 month follow-up.)
- Activity monitoring(Monthly for 12 months after initial two accommodation and training periods)