The Effects of a Wearable Vibratory Device on Biomechanics, Quality of Life and Serum Biomarkers After an ACL Reconstruction Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Knee strength (Newtons)
研究概览
简要总结
Anterior cruciate ligament (ACL) injuries account for up to 25% of knee injuries, it is estimated that 32,000-400,000 new cases of ACL tears occur in the USA every year.
The Standard care is twofold; a) ACL reconstruction surgery and b) prolonged rehabilitation period (usually no less than 9 months). However, a large amount of patients do not return to their pre-injury activity level, and up to 30% reinjure their ACL in the following two years.
The wearable system consists of two non-invasive bands, above and below the knee that vibrate during the weight bearing phase while walking.
详细描述
The objective of this study is to investigate the effect of treatment for ACL reconstruction, including vibrational stimulation and pressure, on locomotion tasks (i.e. walking, stair ascending and descending), muscle function, and pain/function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Males and females
- •Aged 18-50
- •Scheduled for an ACL reconstruction in Rambam hospital.
- •Hebrew language at mother tongue level
排除标准
- •Inability to understand the study protocol.
- •Known neuropathies, active cancer, previous fractures in the lower limbs, inflammatory arthritis, implanted electronic devices of any kind.
- •Allergies to silver or adhesives.
研究组 & 干预措施
Usual care+ Sham device
Each participant will go through the normal rehabilitation process that follows ACL reconstruction+ a sham device used in the same was as the intervention group.
The sham device will look the same, will gave the same pressure around the leg, but will not vibrate.
Usual care+ knee vibratory device
Each participant will go through the normal rehabilitation process that follows ACL reconstruction. Additionally, each participant will receive the active device that applies non-invasive vibrational stimulation to the leg for two months, and will be asked to wear it during ambulation for at least an hour per day.
干预措施: Active vibratory knee device (Device)
Normative data
Healthy participants will go through one session of the full protocol (excluding blood tests):
- Questionnaires (IKDC, TSK, GAD-7).
- Biomechanical analysis during walking, stair ambulation, and hoping.
- Quadriceps and Hamstring strength testing
结局指标
主要结局
Knee strength (Newtons)
时间窗: 6 months post op
Non injured knee, quadriceps and hamstring
Lower limb joints range of motion (Degrees)
时间窗: 6 months post op
Measured by Inertial measurement unit system
Tampa Scale of Kinesiophobia (TSK)
时间窗: 6 months post op
The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia
The International Knee Documentation Committee (IKDC) Subjective Knee Form
时间窗: 6 months post op
The IKDC total score ranges from 0 to 100, where 100 indicates the highest levels of function and lowest levels of symptoms and 0 indicates the lowest level of function or highest level of symptoms.
General Anxiety Disorder-7 (GAD-7)
时间窗: 6 months post op
The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety
Lower limb joints range of motion (Degrees)
时间窗: 4 months post op
Measured by Inertial measurement unit system
Lower limb joints range of motion (Degrees)
时间窗: Pre-surgery
Measured by Inertial measurement unit system
Lower limb joints range of motion (Degrees)
时间窗: 2 months post op
Measured by Inertial measurement unit system
Knee strength (Newtons)
时间窗: Pre-surgery
Non injured knee, quadriceps and hamstring
Knee strength (Newtons)
时间窗: 14 days post op
Non injured knee, quadriceps and hamstring
The International Knee Documentation Committee (IKDC) Subjective Knee Form
时间窗: 2 months post op
The IKDC total score ranges from 0 to 100, where 100 indicates the highest levels of function and lowest levels of symptoms and 0 indicates the lowest level of function or highest level of symptoms.
Knee strength (Newtons)
时间窗: 2 months post op
Non injured knee, quadriceps and hamstring
Knee strength (Newtons)
时间窗: 4 months post op
Non injured knee, quadriceps and hamstring
The International Knee Documentation Committee (IKDC) Subjective Knee Form
时间窗: Pre-surgery
The IKDC total score ranges from 0 to 100, where 100 indicates the highest levels of function and lowest levels of symptoms and 0 indicates the lowest level of function or highest level of symptoms.
The International Knee Documentation Committee (IKDC) Subjective Knee Form
时间窗: 14 days post op
The IKDC total score ranges from 0 to 100, where 100 indicates the highest levels of function and lowest levels of symptoms and 0 indicates the lowest level of function or highest level of symptoms.
The International Knee Documentation Committee (IKDC) Subjective Knee Form
时间窗: 4 months post op
The IKDC total score ranges from 0 to 100, where 100 indicates the highest levels of function and lowest levels of symptoms and 0 indicates the lowest level of function or highest level of symptoms.
General Anxiety Disorder-7 (GAD-7)
时间窗: Pre-surgery
The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety
General Anxiety Disorder-7 (GAD-7)
时间窗: 14 days post op
The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety
General Anxiety Disorder-7 (GAD-7)
时间窗: 2 months post op
The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety
General Anxiety Disorder-7 (GAD-7)
时间窗: 4 months post op
The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety
Tampa Scale of Kinesiophobia (TSK)
时间窗: Pre-surgery
The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia
Tampa Scale of Kinesiophobia (TSK)
时间窗: 14 days post op
The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia
Tampa Scale of Kinesiophobia (TSK)
时间窗: 2 months post op
The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia
Tampa Scale of Kinesiophobia (TSK)
时间窗: 4 months post op
The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia
次要结局
- Surface EMG(6 months post op)
- Single-leg hop for distance (cm)(6 months post op)
- Single-leg drop jump (cm)(6 months post op)
- Serum Biomarkers (ng/mL)(4 months post op)
- Surface Electromyography (EMG)(Pre-surgery)
- Single-leg hop for distance (cm)(4 months post op)
- Single-leg drop jump (cm)(4 months post op, 6 months post op)
- Surface EMG(2 months post op)
- Surface EMG(4 months post op)
- Surface EMG(Pre-surgery)
- Surface EMG(14 days post op)
研究者
Arielle Fischer
Assistant Professor
Technion, Israel Institute of Technology