- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424066
Non-invasive Vibratory Stimulation of the Knee Muscles for the Improvement of the Somatosensory Input and Motor Performance (VIBMOT)
Stimolazione Vibratoria Non-invasiva Per il Miglioramento Del Ritorno Sensoriale e Della Performance Motoria in Atleti Con Lesione al Legamento Crociato Anteriore
The goal of this interventional cross-sectional study is to evaluate motor responses to non-invasive vibratory stimulation applied to the hamstring muscle tendons in healthy individuals. Knee flexion and extension efforts, in both isometric and concentric contractions, will be tested.
The investigators hypothesize that vibratory stimulation causes an increase in activity in the flexor muscles (hamstrings) and a decrease in the extensor muscles (quadriceps) of the knee in all motor tasks. It follows that during knee flexion (both concentric and isometric), vibratory stimulation should cause an increase in the distance between the angular trajectories of the knee obtained with and without vibratory stimulation (with a positive sign). The increased activity of the hamstring muscles would, in fact, contribute to increasing the velocity of the flexor movement. Conversely, during extensor movements (both concentric and isometric), vibratory stimulation should reduce the instantaneous velocity of the movement, therefore causing an increase in distance (with a negative sign) between the trajectories obtained with and without stimulation.
Participants will be tested using an isokinetic dynamometer and they will be asked to perform the following motor tasks in a random order: concentric knee flexion, concentric knee extension, isometric knee flexion, and isometric knee extension. The dominant limb will be tested, only. The assessment will be performed one time.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stefano Scarano, Medical doctor
- Phone Number: +3902619116717
- Email: s.scarano@auxologico.it
Study Locations
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Milan
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Milan, Milan, Italy, 20122
- Recruiting
- Istituto Auxologico Italiano, Clinica Capitanio
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Contact:
- Stefano Scarano, Medical doctor
- Phone Number: +3902619116717
- Email: s.scarano@auxologico.it
-
Contact:
- Cristiano Alessandro, Engineer
- Email: cristiano.alessandro@unimib.it
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Principal Investigator:
- Stefano Scarano, MD
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Sub-Investigator:
- Kevin Soter, M.Sc.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age equal to or greater than 18 years.
Exclusion Criteria:
- Neurological disorders.
- Musculoskeletal injuries, including previous ones, that may compromise the execution of required movements.
- Cardiorespiratory disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy participants
Healthy participants will perform motor tasks with the dominant lower limb, consisting in knee flexion and extension movements in isometric and concentric conditions.
The motor tasks will be performed while a vibratory stimulation is applied to hamstring tendons (treatment) and without vibratory stimulation (control) to assess motor responses.
|
A vibratory stimulator will be applied to the back of the dominant leg, at the level of the hamstring muscle tendons.
The stimulator consists of two small vibrating boxes fixed to the leg by means of an elastic band.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee angle
Time Frame: Day 1.
|
Maximum distance (in degrees) between the knee trajectory obtained with and without vibratory stimulation.
|
Day 1.
|
|
Surface electromyography (sEMG)
Time Frame: Day 1.
|
Difference in sEMG between the muscle activity with and without vibratory stimulation, for each muscle (i.e., Quadriceps, Hamstrings, and Plantarflexor muscles).
|
Day 1.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cristiano Alessandro, Engineering, University of Milano Bicocca
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Prot. Nr. 138/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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