Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

The Effects of a Wearable Vibratory Device on Biomechanics, Quality of Life and Serum Biomarkers After an ACL Reconstruction Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05001594
• Other study ID #: 0089-21-RMB
• Status: Completed
• Phase: N/A
• Start date: January 30, 2022
• Est. completion date: October 7, 2023

Study information

• Verified date: April 2024
• Source: Technion, Israel Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 7, 2023
• Est. primary completion date: October 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Technion, Israel Institute of Technology	Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower limb joints range of motion (Degrees)	Measured by Inertial measurement unit system	Pre-surgery
Primary	Lower limb joints range of motion (Degrees)	Measured by Inertial measurement unit system	2 months post op
Primary	Lower limb joints range of motion (Degrees)	Measured by Inertial measurement unit system	4 months post op
Primary	Lower limb joints range of motion (Degrees)	Measured by Inertial measurement unit system	6 months post op
Primary	Knee strength (Newtons)	Non injured knee, quadriceps and hamstring	Pre-surgery
Primary	Knee strength (Newtons)	Non injured knee, quadriceps and hamstring	14 days post op
Primary	Knee strength (Newtons)	Non injured knee, quadriceps and hamstring	2 months post op
Primary	Knee strength (Newtons)	Non injured knee, quadriceps and hamstring	4 months post op
Primary	Knee strength (Newtons)	Non injured knee, quadriceps and hamstring	6 months post op
Primary	Knee strength (Newtons)	Injured knee, quadriceps and hamstring	Pre-surgery
Primary	Knee strength (Newtons)	Injured knee, quadriceps and hamstring	4 months post op
Primary	Knee strength (Newtons)	Injured knee, quadriceps and hamstring	6 months post op
Primary	The International Knee Documentation Committee (IKDC) Subjective Knee Form	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.	Pre-surgery
Primary	The International Knee Documentation Committee (IKDC) Subjective Knee Form	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.	14 days post op
Primary	The International Knee Documentation Committee (IKDC) Subjective Knee Form	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.	2 months post op
Primary	The International Knee Documentation Committee (IKDC) Subjective Knee Form	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.	4 months post op
Primary	The International Knee Documentation Committee (IKDC) Subjective Knee Form	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.	6 months post op
Primary	General Anxiety Disorder-7 (GAD-7)	The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety	Pre-surgery
Primary	General Anxiety Disorder-7 (GAD-7)	The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety	14 days post op
Primary	General Anxiety Disorder-7 (GAD-7)	The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety	2 months post op
Primary	General Anxiety Disorder-7 (GAD-7)	The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety	4 months post op
Primary	General Anxiety Disorder-7 (GAD-7)	The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety	6 months post op
Primary	Tampa Scale of Kinesiophobia (TSK)	The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia	Pre-surgery
Primary	Tampa Scale of Kinesiophobia (TSK)	The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia	14 days post op
Primary	Tampa Scale of Kinesiophobia (TSK)	The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia	2 months post op
Primary	Tampa Scale of Kinesiophobia (TSK)	The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia	4 months post op
Primary	Tampa Scale of Kinesiophobia (TSK)	The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia	6 months post op
Secondary	Single-leg hop for distance (cm)	Functional assessment	4 months post op
Secondary	Single-leg hop for distance (cm)	Functional assessment	6 months post op
Secondary	Single-leg drop jump (cm)	Functional assessment	4 months post op, 6 months post op
Secondary	Single-leg drop jump (cm)	Functional assessment	6 months post op
Secondary	Serum Biomarkers (ng/mL)	30-minute walk on a treadmill. change in concentration before and after the walk	4 months post op
Secondary	Surface Electromyography (EMG)	Surface EMG assessment of the quadriceps	Pre-surgery
Secondary	Surface EMG	Surface EMG assessment of the quadriceps	2 months post op
Secondary	Surface EMG	Surface EMG assessment of the quadriceps	4 months post op
Secondary	Surface EMG	Surface EMG assessment of the quadriceps	6 months post op
Secondary	Surface EMG	Surface EMG assessment of the hamstrings	Pre-surgery
Secondary	Surface EMG	Surface EMG assessment of the hamstrings	14 days post op
Secondary	Surface EMG	Surface EMG assessment of the hamstrings	2 months post op
Secondary	Surface EMG	Surface EMG assessment of the hamstrings	4 months post op
Secondary	Surface EMG	Surface EMG assessment of the hamstrings	6 months post op