Clinical trial NCT05001594: Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction
Official title: The Effects of a Wearable Vibratory Device on Biomechanics, Quality of Life and Serum Biomarkers After an ACL Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: Knee pathology
Lead sponsor: Technion, Israel Institute of Technology
Sponsor class: OTHER
Collaborators: name: Rambam Health Care Campus
First posted: 2021-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lower limb joints range of motion (Degrees)
timeFrame: Pre-surgery
measure: Lower limb joints range of motion (Degrees)
timeFrame: 2 months post op
measure: Lower limb joints range of motion (Degrees)
timeFrame: 4 months post op
measure: Lower limb joints range of motion (Degrees)
timeFrame: 6 months post op
measure: Knee strength (Newtons)
timeFrame: Pre-surgery
measure: Knee strength (Newtons)
timeFrame: 14 days post op
measure: Knee strength (Newtons)
timeFrame: 2 months post op
measure: Knee strength (Newtons)
timeFrame: 4 months post op
measure: Knee strength (Newtons)
timeFrame: 6 months post op
measure: Knee strength (Newtons)
timeFrame: Pre-surgery
measure: Knee strength (Newtons)
timeFrame: 4 months post op
measure: Knee strength (Newtons)
timeFrame: 6 months post op
measure: The International Knee Documentation Committee (IKDC) Subjective Knee Form
timeFrame: Pre-surgery
measure: The International Knee Documentation Committee (IKDC) Subjective Knee Form
timeFrame: 14 days post op
measure: The International Knee Documentation Committee (IKDC) Subjective Knee Form
timeFrame: 2 months post op
measure: The International Knee Documentation Committee (IKDC) Subjective Knee Form
timeFrame: 4 months post op
measure: The International Knee Documentation Committee (IKDC) Subjective Knee Form
timeFrame: 6 months post op
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Pre-surgery
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: 14 days post op
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: 2 months post op
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: 4 months post op
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: 6 months post op
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: Pre-surgery
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 14 days post op
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 2 months post op
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 4 months post op
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 6 months post op
Secondary outcomes:
measure: Single-leg hop for distance (cm)
timeFrame: 4 months post op
measure: Single-leg hop for distance (cm)
timeFrame: 6 months post op
measure: Single-leg drop jump (cm)
timeFrame: 4 months post op, 6 months post op
measure: Single-leg drop jump (cm)
timeFrame: 6 months post op
measure: Serum Biomarkers (ng/mL)
timeFrame: 4 months post op
measure: Surface Electromyography (EMG)
timeFrame: Pre-surgery
measure: Surface EMG
timeFrame: 2 months post op
measure: Surface EMG
timeFrame: 4 months post op
measure: Surface EMG
timeFrame: 6 months post op
measure: Surface EMG
timeFrame: Pre-surgery
measure: Surface EMG
timeFrame: 14 days post op
measure: Surface EMG
timeFrame: 2 months post op
measure: Surface EMG
timeFrame: 4 months post op
measure: Surface EMG
timeFrame: 6 months post op
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Technion, Israel Institute of Technology
name: Arielle Fischer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Bezalel Peskin, MD
role: PRINCIPAL_INVESTIGATOR
References: