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| Name | Class |
|---|---|
| Rambam Health Care Campus | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care+ Sham device | No Intervention | 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 | Experimental | 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. |
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| Normative data | No Intervention | Healthy participants will go through one session of the full protocol (excluding blood tests):
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active vibratory knee device | Device | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arielle Fischer, PhD | Technion, Israel Institute of Technology | Principal Investigator |
| Bezalel Peskin, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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|
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 |
| 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 |