Mobile Device Outcomes-based Rehabilitation Program
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Timed Up and Go (TUG)
研究概览
简要总结
This joint research project between the Department of Veterans Affairs (VA) and Department of Defense (DoD) will demonstrate that the implementation of the Mobile Device Outcomes-based Rehabilitation Program (MDORP) will improve the quality of rehabilitative care at a decreased cost to the healthcare system and a reduced burden for service members (SMs) and veterans with lower limb loss. The development of the MDORP will be executed by a multisite translational clinical care team that will use web-based mobile computing devices designed to assess mobility, enable remote prescription of targeted exercise program, and provide continual measureable outcomes to document the continuum of care with the intent of maximizing prosthetic performance while minimizing adverse medical events. The information obtained from this web-based mobile device application will be used by clinicians to promote continuity of care from the DoD and VA facilities nationwide to the community and at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The following inclusion and
排除标准
- •will be used to determine eligibility for the veterans with lower limb loss to participate in the study at the Miami VA and SMs at WRNMMC.
- •Inclusion Criteria:
- •DEERS eligible Veterans/SMs with major unilateral or bilateral lower limb loss at the Symes, Transtibial, Knee Disarticulation, and/or Transfemoral amputation levels
- •At least 3 months from initial prosthetic fitting and cleared for at home prosthetic use.
- •Male and Females between 20 - 80 years of age
- •Determined to be medically stable before participation in the study
- •Currently have a well-fitting and properly aligned prosthesis
- •Can independently perform exercises at home
- •Demonstrate basic proficiency with use of tablet technology
- •Exclusion criteria:
- •Spinal cord injury or lower limb paralysis
- •Complete or partial peripheral nerve injury limiting physical performance or increase risk of injury
- •Cognitively unable to complete the self-report questionnaires or use tablet technology
- •No valid contact information
- •Amputation of only toes or upper limb only
- •Amputation of upper and lower limb
- •The subject is deemed as living too far away for the physical therapist to conduct home visits.
- •Evidence of any nerve or brain disorders that affect motion
- •Unable to speak or understand English
- •The subject does not have the capacity to provide consent.
- •The following inclusion and exclusion criteria will be used to determine eligibility for the CONTROL subjects to participate in phase I of the study at WRNMMC.
- •Inclusion Criteria:
- •DEERS Eligible males and females between 20-65 years of age
- •Determined to be medically stable before participation in the study
- •No history of upper or lower limb loss
- •Exclusion Criteria:
- •Evidence of paralysis or other lower limb dysfunction.
- •Complete or partial peripheral nerve injury limiting physical performance or increase risk of injury
- •Cognitively unable to follow study instructions
- •Amputation of upper or lower limb
- •Unable to walk 100 meters without an assistive device (cane, walker, etc)
- •History of cardiovascular disease that would limit ambulation 100 meters
- •Reported symptoms of chest pain or shortness of breath
- •Evidence of any nerve or brain disorders that affect motion
- •Unable to speak or understand English
- •The subject does not have the capacity to provide consent.
研究组 & 干预措施
Control Group
The investigators will recruit 20 healthy subjects at Walter Reed National Military Medical Center (WRNMMC) with the goal of consenting and enrolling 15 healthy subjects to assess the reliability and validity the wearable Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD) system.
干预措施: Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD) (Device)
Amputee Group
The investigators will recruit a total of 130 subjects (65 at WRNMMC and 65 at the Miami VA) with the goal of consenting and enrolling 100 subjects (50 and WRNMMC and 50 at the Miami VA) with lower limb amputation to utilize the ReLOAD system.
干预措施: Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD) (Device)
结局指标
主要结局
Change in Timed Up and Go (TUG)
时间窗: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The TUG is a measure of basic mobility that assesses the time to complete a sit to stand activity from a standard height chair, ambulate less than 10 feet, perform a turning activity, ambulate back to the chair and perform stand to sit activity. It is a measure of mobility and predictor of falls risk.
Change in Six-minute Walk Test (6MWT)
时间窗: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The 6MWT has been found to be a measure of overall mobility and physical functioning in the lower limb amputee population and geriatric population. It will be used to provide an overall measure of mobility and musculoskeletal endurance.
Change in Amputee Mobility Predictor (AMP)
时间窗: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The AMP is a 21 item clinical tool that assesses current functional capability and mobility with a prosthesis when performing basic daily activities. The AMP assesses the ability of an amputee to complete 20 different items that progress in level of difficulty. Higher AMP scores indicate greater prosthetic ambulation capabilities.
Change in Bilateral-Amputee Mobility Predictor (BAMP)
时间窗: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The BAMP is the AMP adapted for those with bilateral lower limb loss.
Change in Comprehensive High-level Activity Mobility Predictor (CHAMP)
时间窗: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The CHAMP is a clinical tool that assesses an individual's capabilities in performing high-level mobility and agility activities in multiple planes of motion. It consists of four tests (Single Limb Stance, Edgren Side Step Test, T-Test, and Illinois Agility Test) and generates a total score that indicates greater high-level mobility capabilities.
Change in Symmetry of External Work (SEW)
时间窗: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The SEW is a biomechanical outcome measure for assessing dynamic movement symmetry during functional activities. SEW values represent the effort undertaken by each lower-limb in moving the body forward during walking. It will be assessed simultaneously with the TUG, AMP, 6MWT, and CHAMP.
Change in Modified Test of Sensory Integration and Balance (mCTSIB)
时间窗: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
The mCTSIB is a test to describe postural control under various sensory conditions. The test requires subjects to maintain balance for 30 seconds in four conditions: firm surface with eyes open, firm surface with eyes closed, standing on foam with eyes open, and standing on foam with eyes closed.
次要结局
- Weight(Baseline)
- Bandura's Self-efficacy Survey(Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up)
- Charleson Co-Morbidity Index(Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up)
- New Injury Severity Score(Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up)
- Patient Reported Outcome Measure Information System (PROMIS)(Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up)
- International Physical Activity Questionnaire (IPAQ)(Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up)
- Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R)(Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up)
- Prosthetic Limb Users Survey- Mobility (PLUS-M)(Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up)
- Socket Fit Comfort Scale(Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up)
- Activities-specific balance confidence scale (ABC)(Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up)
- Modified Oswestry Low Back Pain Disability Index (MODI)(Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up)
- Lower Extremity Functional Scale (LEFS)(Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up)
- Body Mass Index(Baseline)
- Waist Circumference(Baseline)
- Height(Baseline)
- Hip Circumference(Baseline)