Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Device: Active vibratory knee device

• Registration Number: NCT05001594
• Lead Sponsor: Technion, Israel Institute of Technology

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.

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-12
• Study Start: 2022-01-30
• Primary Completion: 2023-10-07
• Study Completion: 2023-10-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care+ knee vibratory device	Active vibratory knee device	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.

Primary Outcome Measures

Name	Time	Method
Lower limb joints range of motion (Degrees)	6 months post op	Measured by Inertial measurement unit system
Tampa Scale of Kinesiophobia (TSK)	6 months post op	The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia
Knee strength (Newtons)	6 months post op	Injured knee, quadriceps and hamstring
The International Knee Documentation Committee (IKDC) Subjective Knee Form	6 months post op	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)	6 months post op	The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety

Secondary Outcome Measures

Name	Time	Method
Single-leg hop for distance (cm)	6 months post op	Functional assessment
Single-leg drop jump (cm)	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	6 months post op	Surface EMG assessment of the hamstrings

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel