Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of a Wearable Vibratory Device on Biomechanics, Quality of Life and Serum Biomarkers After an ACL Reconstruction Surgery

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Device: Active vibratory knee device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care+ Sham device<br>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. | |
| Experimental: Usual care+ knee vibratory device<br>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. | Device: Active vibratory knee device<br>* The active, wearable device is placed above and below the knee joint. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide vibratory feedback to the subject.<br>|
| No Intervention: Normative data<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower limb joints range of motion (Degrees) | Measured by Inertial measurement unit system | Pre-surgery | 
| Lower limb joints range of motion (Degrees) | Measured by Inertial measurement unit system | 2 months post op | 
| Lower limb joints range of motion (Degrees) | Measured by Inertial measurement unit system | 4 months post op | 
| Lower limb joints range of motion (Degrees) | Measured by Inertial measurement unit system | 6 months post op | 
| Knee strength (Newtons) | Non injured knee, quadriceps and hamstring | Pre-surgery | 
| Knee strength (Newtons) | Non injured knee, quadriceps and hamstring | 14 days post op | 
| Knee strength (Newtons) | Non injured knee, quadriceps and hamstring | 2 months post op | 
| Knee strength (Newtons) | Non injured knee, quadriceps and hamstring | 4 months post op | 
| Knee strength (Newtons) | Non injured knee, quadriceps and hamstring | 6 months post op | 
| Knee strength (Newtons) | Injured knee, quadriceps and hamstring | Pre-surgery | 
| Knee strength (Newtons) | Injured knee, quadriceps and hamstring | 4 months post op | 
| Knee strength (Newtons) | Injured knee, quadriceps and hamstring | 6 months post op | 
| The International Knee Documentation Committee (IKDC) Subjective Knee Form | 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. | Pre-surgery | 
| The International Knee Documentation Committee (IKDC) Subjective Knee Form | 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. | 14 days post op | 
| The International Knee Documentation Committee (IKDC) Subjective Knee Form | 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. | 2 months post op | 
| The International Knee Documentation Committee (IKDC) Subjective Knee Form | 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. | 4 months post op | 
| The International Knee Documentation Committee (IKDC) Subjective Knee Form | 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. | 6 months post op | 
| General Anxiety Disorder-7 (GAD-7) | The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety | Pre-surgery | 
| General Anxiety Disorder-7 (GAD-7) | The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety | 14 days post op | 
| General Anxiety Disorder-7 (GAD-7) | The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety | 2 months post op | 
| General Anxiety Disorder-7 (GAD-7) | The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety | 4 months post op | 
| General Anxiety Disorder-7 (GAD-7) | The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety | 6 months post op | 
| Tampa Scale of Kinesiophobia (TSK) | The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia | Pre-surgery | 
| Tampa Scale of Kinesiophobia (TSK) | The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia | 14 days post op | 
| Tampa Scale of Kinesiophobia (TSK) | The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia | 2 months post op | 
| Tampa Scale of Kinesiophobia (TSK) | The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia | 4 months post op | 
| Tampa Scale of Kinesiophobia (TSK) | The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia | 6 months post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single-leg hop for distance (cm) | Functional assessment | 4 months post op | 
| Single-leg hop for distance (cm) | Functional assessment | 6 months post op | 
| Single-leg drop jump (cm) | Functional assessment | 4 months post op, 6 months post op | 
| Single-leg drop jump (cm) | Functional assessment | 6 months post op | 
| Serum Biomarkers (ng/mL) | 30-minute walk on a treadmill. change in concentration before and after the walk | 4 months post op | 
| Surface Electromyography (EMG) | Surface EMG assessment of the quadriceps | Pre-surgery | 
| Surface EMG | Surface EMG assessment of the quadriceps | 2 months post op | 
| Surface EMG | Surface EMG assessment of the quadriceps | 4 months post op | 
| Surface EMG | Surface EMG assessment of the quadriceps | 6 months post op | 
| Surface EMG | Surface EMG assessment of the hamstrings | Pre-surgery | 
| Surface EMG | Surface EMG assessment of the hamstrings | 14 days post op | 
| Surface EMG | Surface EMG assessment of the hamstrings | 2 months post op | 
| Surface EMG | Surface EMG assessment of the hamstrings | 4 months post op | 
| Surface EMG | Surface EMG assessment of the hamstrings | 6 months post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee pathology