Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction
NCT ID: NCT05001594
Last Updated: 2024-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-01-30
2023-10-07
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Usual care+ Sham device
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.
No interventions assigned to this group
Usual care+ knee vibratory device
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.
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.
Normative data
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
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Males and females
* Aged 18-50
* Scheduled for an ACL reconstruction in Rambam hospital.
* Hebrew language at mother tongue level
Exclusion Criteria
* Known neuropathies, active cancer, previous fractures in the lower limbs, inflammatory arthritis, implanted electronic devices of any kind.
* Allergies to silver or adhesives.
18 Years
50 Years
ALL
No
Sponsors
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Rambam Health Care Campus
OTHER
Technion, Israel Institute of Technology
OTHER
Responsible Party
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Arielle Fischer
Assistant Professor
Principal Investigators
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Arielle Fischer, PhD
Role: PRINCIPAL_INVESTIGATOR
Technion, Israel Institute of Technology
Bezalel Peskin, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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Rambam Health Care Campus
Haifa, , Israel
Countries
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Other Identifiers
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0089-21-RMB
Identifier Type: -
Identifier Source: org_study_id
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