NCT03930056进行中（未招募）不适用
Micro-Processor Controlled Knee-Ankle-Foot Orthosis (C-Brace) Usage in a Spinal Cord Injury (SCI) Population Compared to Traditional Rehabilitation Methods: Determining Functional Outcome Differences of Recovery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Six Minute Walk Test (6MWT)
研究概览
简要总结
A randomized, repeated measures comparative design study to compare use of a micro-processor controlled knee-ankle-foot orthosis vs. traditional care knee-ankle-foot-orthosis (KAFO) models following discharge from inpatient rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Be within 3-24 months post spinal cord injury diagnosis
- •18-80 years
- •Must be able to demonstrate the ability to charge assigned sensors during 3-month home trial period on and off and sufficient memory ability to wear the devices each day during use of the orthoses.
排除标准
- •Unstable neurological, cardiovascular, or cancer diagnoses.
- •Cognitive impairments that limit study participation
- •In addition to the above inclusion criteria, the following criteria must be met to be designated into the study interventional tract (C-Brace II):
- •Inclusion criteria:
- •Requires orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally
- •Exclusion criteria:
- •Body weight over 275 lbs
- •Flexion contracture in the knee and/or hip joint in excess of 10 degrees
- •Non-correctable knee varus/valgus in excess of 10 degrees
- •Moderate to severe spasticity
- •Leg length discrepancy in excess of 6" (15.24 cm)
- •Inability to stabilize the trunk with or without assistive devices (crutches, cane, etc.)
- •Inability to successfully use C-Brace trial tool in advancement of leg/s.
结局指标
主要结局
Six Minute Walk Test (6MWT)
时间窗: Change from baseline in 6MWT distance after using device at 3, 6, and 12 month follow-up.
The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.
次要结局
- Functional Gait Assessment (FGA)(Change from baseline in FGA score after using device at 3, 6, and 12 month follow-up.)
- 10 Meter Walk Test (10MWT)(Change from baseline in gait speed after using device at 3, 6, and 12 month follow-up.)
- Muscle Strength (manual muscle test)(Change from baseline in muscle strength after using device at 3, 6, and 12 month follow-up.)
- Passive and Active Range of Motion of Lower Extremity joints(Change from baseline in range of motion after using device at 3, 6, and 12 month follow-up.)
- Modified Ashworth Scale(Change from baseline in muscle tone after using device at 3, 6, and 12 month follow-up.)
- Berg Balance Scale (BBS)(Change from baseline in Berg Balance score after using device at 3, 6, and 12 month follow-up.)
- Timed Up and Go test (TUG)(Change from baseline in TUG score after using device at 3, 6, and 12 month follow-up.)
- Walking Index for Spinal Cord Injury (WISCI II)(Change from baseline in rank score after using device at 3, 6, and 12 month follow-up.)
- Gaitrite data capture(Change from baseline in gait parameters after using device at 3, 6, and 12 month follow-up.)
研究者
Arun Jayaraman, PT, PhD
Research Scientist
Shirley Ryan AbilityLab
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Assessing Outcomes With Microprocessor Knee Utilization in a K2 PopulationLower Limb Amputation Above Knee (Injury)Congenital Amputation of Lower LimbLower Limb Amputation KneeNCT04784429Otto Bock Healthcare Products GmbH107
已完成
不适用
Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial AmputeesAmputationNCT02864693Ability Prosthetics and Orthotics, Inc.30
尚未招募
不适用
The Effect of Microprocessor Controlled Prostheses on Walking Pattern and Energy ConsumptionAmputation, TraumaticGaitNCT05786690Gaziler Physical Medicine and Rehabilitation Education and Research Hospital34
已完成
不适用
C-Leg 3 and C-Leg 4 Study in Transfemoral AmputeesLower Limb Amputation Above Knee (Injury)NCT02765035Otto Bock Healthcare Products GmbH18
已完成
不适用
Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)AmputationLower Limb Amputation Above Knee (Injury)NCT06522646Institution Nationale des Invalides12