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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
Rambam Health Care Campus
Haifa, Israel
Lower limb joints range of motion (Degrees)
Measured by Inertial measurement unit system
Time frame: Pre-surgery
Lower limb joints range of motion (Degrees)
Measured by Inertial measurement unit system
Time frame: 2 months post op
Lower limb joints range of motion (Degrees)
Measured by Inertial measurement unit system
Time frame: 4 months post op
Lower limb joints range of motion (Degrees)
Measured by Inertial measurement unit system
Time frame: 6 months post op
Knee strength (Newtons)
Non injured knee, quadriceps and hamstring
Time frame: Pre-surgery
Knee strength (Newtons)
Non injured knee, quadriceps and hamstring
Time frame: 14 days post op
Knee strength (Newtons)
Non injured knee, quadriceps and hamstring
Time frame: 2 months post op
Knee strength (Newtons)
Non injured knee, quadriceps and hamstring
Time frame: 4 months post op
Knee strength (Newtons)
Non injured knee, quadriceps and hamstring
Time frame: 6 months post op
Knee strength (Newtons)
Injured knee, quadriceps and hamstring
Time frame: Pre-surgery
Knee strength (Newtons)
Injured knee, quadriceps and hamstring
Time frame: 4 months post op
Knee strength (Newtons)
Injured knee, quadriceps and hamstring
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months post op
Single-leg hop for distance (cm)
Functional assessment
Time frame: 4 months post op
Single-leg hop for distance (cm)
Functional assessment
Time frame: 6 months post op
Single-leg drop jump (cm)
Functional assessment
Time frame: 4 months post op, 6 months post op
Single-leg drop jump (cm)
Functional assessment
Time frame: 6 months post op
Serum Biomarkers (ng/mL)
30-minute walk on a treadmill. change in concentration before and after the walk
Time frame: 4 months post op
Surface Electromyography (EMG)
Surface EMG assessment of the quadriceps
Time frame: Pre-surgery
Surface EMG
Surface EMG assessment of the quadriceps
Time frame: 2 months post op
Surface EMG
Surface EMG assessment of the quadriceps
Time frame: 4 months post op
Surface EMG
Surface EMG assessment of the quadriceps
Time frame: 6 months post op
Surface EMG
Surface EMG assessment of the hamstrings
Time frame: Pre-surgery
Surface EMG
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Surface EMG assessment of the hamstrings
Time frame: 14 days post op
Surface EMG
Surface EMG assessment of the hamstrings
Time frame: 2 months post op
Surface EMG
Surface EMG assessment of the hamstrings
Time frame: 4 months post op
Surface EMG
Surface EMG assessment of the hamstrings
Time frame: 6 months post op