Anterior Cruciate Ligament Injuries
Conditions
Keywords
Knee pathology
Brief summary
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
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.
Interventions
DEVICEActive vibratory knee 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.
Sponsors
Rambam Health Care Campus
Technion, Israel Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tampa Scale of Kinesiophobia (TSK) | Pre-surgery | The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia |
| Lower limb joints range of motion (Degrees) | Pre-surgery | Measured by Inertial measurement unit system |
| Knee strength (Newtons) | Pre-surgery | Non injured knee, quadriceps and hamstring |
| The International Knee Documentation Committee (IKDC) Subjective Knee Form | 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. |
| General Anxiety Disorder-7 (GAD-7) | Pre-surgery | The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single-leg hop for distance (cm) | 4 months post op | Functional assessment |
| Single-leg drop jump (cm) | 4 months post op, 6 months post op | Functional assessment |
| Serum Biomarkers (ng/mL) | 4 months post op | 30-minute walk on a treadmill. change in concentration before and after the walk |
| Surface Electromyography (EMG) | Pre-surgery | Surface EMG assessment of the quadriceps |
| Surface EMG | 2 months post op | Surface EMG assessment of the quadriceps |
Countries
Israel
Outcome results
None listed