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Completed

NCT Number: NCT05001594

Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus

Haifa, 3109601, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active vibratory knee device

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.

Primary outcomes

  1. Lower limb joints range of motion (Degrees)

    Time frame: Pre-surgery

    Measured by Inertial measurement unit system

  2. Lower limb joints range of motion (Degrees)

    Time frame: 2 months post op

    Measured by Inertial measurement unit system

  3. Lower limb joints range of motion (Degrees)

    Time frame: 4 months post op

    Measured by Inertial measurement unit system

  4. Lower limb joints range of motion (Degrees)

    Time frame: 6 months post op

    Measured by Inertial measurement unit system

  5. Knee strength (Newtons)

    Time frame: Pre-surgery

    Non injured knee, quadriceps and hamstring

  6. Knee strength (Newtons)

    Time frame: 14 days post op

    Non injured knee, quadriceps and hamstring

  7. Knee strength (Newtons)

    Time frame: 2 months post op

    Non injured knee, quadriceps and hamstring

  8. Knee strength (Newtons)

    Time frame: 4 months post op

    Non injured knee, quadriceps and hamstring

  9. Knee strength (Newtons)

    Time frame: 6 months post op

    Non injured knee, quadriceps and hamstring

  10. Knee strength (Newtons)

    Time frame: Pre-surgery

    Injured knee, quadriceps and hamstring

  11. Knee strength (Newtons)

    Time frame: 4 months post op

    Injured knee, quadriceps and hamstring

  12. Knee strength (Newtons)

    Time frame: 6 months post op

    Injured knee, quadriceps and hamstring

  13. The International Knee Documentation Committee (IKDC) Subjective Knee Form

    Time frame: Pre-surgery

    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. The International Knee Documentation Committee (IKDC) Subjective Knee Form

    Time frame: 14 days 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.

  15. The International Knee Documentation Committee (IKDC) Subjective Knee Form

    Time frame: 2 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.

  16. The International Knee Documentation Committee (IKDC) Subjective Knee Form

    Time frame: 4 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.

  17. The International Knee Documentation Committee (IKDC) Subjective Knee Form

    Time frame: 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.

  18. General Anxiety Disorder-7 (GAD-7)

    Time frame: Pre-surgery

    The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety

  19. General Anxiety Disorder-7 (GAD-7)

    Time frame: 14 days post op

    The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety

  20. General Anxiety Disorder-7 (GAD-7)

    Time frame: 2 months post op

    The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety

  21. General Anxiety Disorder-7 (GAD-7)

    Time frame: 4 months post op

    The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety

  22. General Anxiety Disorder-7 (GAD-7)

    Time frame: 6 months post op

    The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety

  23. Tampa Scale of Kinesiophobia (TSK)

    Time frame: Pre-surgery

    The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia

  24. Tampa Scale of Kinesiophobia (TSK)

    Time frame: 14 days post op

    The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia

  25. Tampa Scale of Kinesiophobia (TSK)

    Time frame: 2 months post op

    The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia

  26. Tampa Scale of Kinesiophobia (TSK)

    Time frame: 4 months post op

    The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia

  27. Tampa Scale of Kinesiophobia (TSK)

    Time frame: 6 months post op

    The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia

Secondary outcomes

  1. Single-leg hop for distance (cm)

    Time frame: 4 months post op

    Functional assessment

  2. Single-leg hop for distance (cm)

    Time frame: 6 months post op

    Functional assessment

  3. Single-leg drop jump (cm)

    Time frame: 4 months post op, 6 months post op

    Functional assessment

  4. Single-leg drop jump (cm)

    Time frame: 6 months post op

    Functional assessment

  5. Serum Biomarkers (ng/mL)

    Time frame: 4 months post op

    30-minute walk on a treadmill. change in concentration before and after the walk

  6. Surface Electromyography (EMG)

    Time frame: Pre-surgery

    Surface EMG assessment of the quadriceps

  7. Surface EMG

    Time frame: 2 months post op

    Surface EMG assessment of the quadriceps

  8. Surface EMG

    Time frame: 4 months post op

    Surface EMG assessment of the quadriceps

  9. Surface EMG

    Time frame: 6 months post op

    Surface EMG assessment of the quadriceps

  10. Surface EMG

    Time frame: Pre-surgery

    Surface EMG assessment of the hamstrings

  11. Surface EMG

    Time frame: 14 days post op

    Surface EMG assessment of the hamstrings

  12. Surface EMG

    Time frame: 2 months post op

    Surface EMG assessment of the hamstrings

  13. Surface EMG

    Time frame: 4 months post op

    Surface EMG assessment of the hamstrings

  14. Surface EMG

    Time frame: 6 months post op

    Surface EMG assessment of the hamstrings

Sponsors and collaborators

Lead sponsor

Technion, Israel Institute of Technology

Other

Collaborators

  • Rambam Health Care Campus

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2021
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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