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Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction

NCT05001594 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-11

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament Injuries

Interventions

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.

Sponsors & Collaborators

  • Rambam Health Care Campus

    collaborator OTHER

  • Technion, Israel Institute of Technology

    lead OTHER

Principal Investigators

  • Arielle Fischer, PhD · Technion, Israel Institute of Technology

  • Bezalel Peskin, MD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-30
Primary Completion
2023-10-07
Completion
2023-10-07

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05001594 on ClinicalTrials.gov