Anterior Cruciate Ligament InjuriesNCT05001594
Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction
A study testing Active vibratory knee device in people with Anterior Cruciate Ligament Injuries, run by Technion, Israel Institute of Technology at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Active vibratory knee device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jan 2022to 7 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Wearable Vibratory Device on Biomechanics, Quality of Life and Serum Biomarkers After an ACL Reconstruction Surgery
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Active vibratory knee device
- Keywords
- Knee pathology
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb joints range of motion (Degrees)
Measured by Inertial measurement unit system
Measured: Pre-surgery
Lower limb joints range of motion (Degrees)
Measured by Inertial measurement unit system
Measured: 2 months post op
Lower limb joints range of motion (Degrees)
Measured by Inertial measurement unit system
Measured: 4 months post op
Lower limb joints range of motion (Degrees)
Measured by Inertial measurement unit system
Measured: 6 months post op
Knee strength (Newtons)
Non injured knee, quadriceps and hamstring
Measured: Pre-surgery
Knee strength (Newtons)
Non injured knee, quadriceps and hamstring
Measured: 14 days post op
Knee strength (Newtons)
Non injured knee, quadriceps and hamstring
Measured: 2 months post op
Knee strength (Newtons)
Non injured knee, quadriceps and hamstring
Measured: 4 months post op
Knee strength (Newtons)
Non injured knee, quadriceps and hamstring
Measured: 6 months post op
Knee strength (Newtons)
Injured knee, quadriceps and hamstring
Measured: Pre-surgery
Knee strength (Newtons)
Injured knee, quadriceps and hamstring
Measured: 4 months post op
Knee strength (Newtons)
Injured knee, quadriceps and hamstring
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months post op
Secondary outcomes (14)
Single-leg hop for distance (cm)
Functional assessment
Measured: 4 months post op
Single-leg hop for distance (cm)
Functional assessment
Measured: 6 months post op
Single-leg drop jump (cm)
Functional assessment
Measured: 4 months post op, 6 months post op
Single-leg drop jump (cm)
Functional assessment
Measured: 6 months post op
Serum Biomarkers (ng/mL)
30-minute walk on a treadmill. change in concentration before and after the walk
Measured: 4 months post op
Surface Electromyography (EMG)
Surface EMG assessment of the quadriceps
Measured: Pre-surgery
Surface EMG
Surface EMG assessment of the quadriceps
Measured: 2 months post op
Surface EMG
Surface EMG assessment of the quadriceps
Measured: 4 months post op
Surface EMG
Surface EMG assessment of the quadriceps
Measured: 6 months post op
Surface EMG
Surface EMG assessment of the hamstrings
Measured: Pre-surgery
Surface EMG
Surface EMG assessment of the hamstrings
Measured: 14 days post op
Surface EMG
Surface EMG assessment of the hamstrings
Measured: 2 months post op
Surface EMG
Surface EMG assessment of the hamstrings
Measured: 4 months post op
Surface EMG
Surface EMG assessment of the hamstrings
Measured: 6 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start30 Jan 2022
- Primary completion7 Oct 2023
- Study completion7 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technion, Israel Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Rambam Health Care Campus
- Responsible party
- Principal investigator, Arielle Fischer, Technion, Israel Institute of Technology
- Investigators
- Arielle Fischer, PhD, Principal investigator, Technion, Israel Institute of TechnologyBezalel Peskin, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001594
- Sponsor's protocol ID
- 0089-21-RMB
- Status last verified
- Apr 2024
- First submitted
- 22 Jul 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Wearable Vibratory Device on Biomechanics, Quality of Life and Serum Biomarkers After an ACL Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT05001594
- Acronym / sponsor ID
- 0089-21-RMB
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- Knee pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Technion, Israel Institute of TechnologyUniversity, hospital or other
- Collaborators
- Rambam Health Care Campus
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 7 Oct 2023 (actual)
- Study completion
- 7 Oct 2023 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Active vibratory knee deviceEach 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. |
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active vibratory knee deviceThe 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. | Device | Usual care+ knee vibratory device |
Primary outcome
Lower limb joints range of motion (Degrees)
Time frame: Pre-surgery
Measured by Inertial measurement unit system
Lower limb joints range of motion (Degrees)
Time frame: 2 months post op
Measured by Inertial measurement unit system
Lower limb joints range of motion (Degrees)
Time frame: 4 months post op
Measured by Inertial measurement unit system
Lower limb joints range of motion (Degrees)
Time frame: 6 months post op
Measured by Inertial measurement unit system
Knee strength (Newtons)
Time frame: Pre-surgery
Non injured knee, quadriceps and hamstring
Knee strength (Newtons)
Time frame: 14 days post op
Non injured knee, quadriceps and hamstring
Knee strength (Newtons)
Time frame: 2 months post op
Non injured knee, quadriceps and hamstring
Knee strength (Newtons)
Time frame: 4 months post op
Non injured knee, quadriceps and hamstring
Knee strength (Newtons)
Time frame: 6 months post op
Non injured knee, quadriceps and hamstring
Knee strength (Newtons)
Time frame: Pre-surgery
Injured knee, quadriceps and hamstring
Knee strength (Newtons)
Time frame: 4 months post op
Injured knee, quadriceps and hamstring
Knee strength (Newtons)
Time frame: 6 months post op
Injured knee, quadriceps and hamstring
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.
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.
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.
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.
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.
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
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
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
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
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
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
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
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
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
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
14 secondary outcomes
Single-leg hop for distance (cm)
Time frame: 4 months post op
Single-leg hop for distance (cm)
Time frame: 6 months post op
Single-leg drop jump (cm)
Time frame: 4 months post op, 6 months post op
Single-leg drop jump (cm)
Time frame: 6 months post op
Serum Biomarkers (ng/mL)
Time frame: 4 months post op
Surface Electromyography (EMG)
Time frame: Pre-surgery
Surface EMG
Time frame: 2 months post op
Surface EMG
Time frame: 4 months post op
Surface EMG
Time frame: 6 months post op
Surface EMG
Time frame: Pre-surgery
Surface EMG
Time frame: 14 days post op
Surface EMG
Time frame: 2 months post op
Surface EMG
Time frame: 4 months post op
Surface EMG
Time frame: 6 months post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arielle Fischer, PhD principal investigator
Technion, Israel Institute of Technology
Bezalel Peskin, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active vibratory knee device in people with Anterior Cruciate Ligament Injuries, run by Technion, Israel Institute of Technology at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower limb joints range of motion (Degrees) (time frame: Pre-surgery). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.