NCT05001594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 30, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2023

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

July 22, 2021

Last Update Submit

April 10, 2024

Conditions

Anterior Cruciate Ligament Injuries

Keywords

Knee pathology

Outcome Measures

Primary Outcomes (27)

  • Lower limb joints range of motion (Degrees)

    Measured by Inertial measurement unit system

    Pre-surgery

  • Lower limb joints range of motion (Degrees)

    Measured by Inertial measurement unit system

    2 months post op

  • Lower limb joints range of motion (Degrees)

    Measured by Inertial measurement unit system

    4 months post op

  • Lower limb joints range of motion (Degrees)

    Measured by Inertial measurement unit system

    6 months post op

  • Knee strength (Newtons)

    Non injured knee, quadriceps and hamstring

    Pre-surgery

  • Knee strength (Newtons)

    Non injured knee, quadriceps and hamstring

    14 days post op

  • Knee strength (Newtons)

    Non injured knee, quadriceps and hamstring

    2 months post op

  • Knee strength (Newtons)

    Non injured knee, quadriceps and hamstring

    4 months post op

  • Knee strength (Newtons)

    Non injured knee, quadriceps and hamstring

    6 months post op

  • Knee strength (Newtons)

    Injured knee, quadriceps and hamstring

    Pre-surgery

  • Knee strength (Newtons)

    Injured knee, quadriceps and hamstring

    4 months post op

  • Knee strength (Newtons)

    Injured knee, quadriceps and hamstring

    6 months post op

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (14)

  • Single-leg hop for distance (cm)

    4 months post op

  • Single-leg hop for distance (cm)

    6 months post op

  • Single-leg drop jump (cm)

    4 months post op, 6 months post op

  • Single-leg drop jump (cm)

    6 months post op

  • Serum Biomarkers (ng/mL)

    4 months post op

  • +9 more secondary outcomes

Study Arms (3)

Usual care+ Sham device

NO INTERVENTION

Each participant will go through the normal rehabilitation process that follows ACL reconstruction+ a sham device used in the same was as the intervention group. The sham device will look the same, will gave the same pressure around the leg, but will not vibrate.

Usual care+ knee vibratory device

EXPERIMENTAL

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.

Device: Active vibratory knee device

Normative data

NO INTERVENTION

Healthy participants will go through one session of the full protocol (excluding blood tests): * Questionnaires (IKDC, TSK, GAD-7). * Biomechanical analysis during walking, stair ambulation, and hoping. * Quadriceps and Hamstring strength testing

Interventions

Active vibratory knee deviceDEVICE

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.

Usual care+ knee vibratory device

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Arielle Fischer, PhD

    Technion, Israel Institute of Technology

    PRINCIPAL INVESTIGATOR

  • Bezalel Peskin, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 22, 2021

First Posted

August 12, 2021

Study Start

January 30, 2022

Primary Completion

October 7, 2023

Study Completion

October 7, 2023

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations

IL(1)