Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction

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

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.

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.

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.

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

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.

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 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 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 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 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 GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety

The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety

The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety

The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety

The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety

The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia

The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia

The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia

The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia

The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia

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.