NCT05001594

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Technion, Israel Institute of Technology · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anterior Cruciate Ligament Injuries

Interventions

Type	Name	Description
DEVICE	Active 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.

Timeline

• Start date: 2022-01-30
• Primary completion: 2023-10-07
• Completion: 2023-10-07
• First posted: 2021-08-12
• Last updated: 2024-04-11

Locations

1 site across 1 country: Israel