Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction

Technion, Israel Institute of Technology

Status: Completed

Conditions: Anterior Cruciate Ligament Injuries

Treatments: Device: Active vibratory knee device

Study type: Interventional

Funder types: Other

Identifiers

NCT05001594

0089-21-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Usual care+ Sham device

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: Active vibratory knee device

Normative data

No Intervention group

Description:

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