- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06936020
Effects of Peripheral Somatosensory Stimulation Via Mechanical Pressure on Lower Limb Muscle Strength in Healthy Subjects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: To determine whether the application of a peripheral proprioceptive stimulus to the neuromuscular motor points of the quadriceps increases strength and neuromuscular activation during the squat movement in the lower limbs of healthy, untrained subjects.
Methods: The design of this study is a randomized crossover clinical trial. All participants (n=36) will randomly receive both the Active and Sham proprioceptive stimulation.The proprioceptive stimulus will consist of intermittent mechanical pressure on the skin, localized at the neuromuscular motor points of the rectus femoris, vastus lateralis, and vastus medialis of the quadriceps. The tissue subjected to precise pressure in these highly innervated neuromuscular zones promotes the stimulation of kinesthetic cortical sensitivity. The outcome variable will be the assessment of Maximum Strength (MS) generated by the participant during the squat movement, from a 90º knee flexion position to full extension. At the moment of peak force, the mean velocity (MV) of the concentric phase of the movement and the maximum load the participant can move will be evaluated. The intervention, assessment, and recruitment will take place at the Faculty of Health Sciences, Blanquerna - Ramon Llull University
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pedro V López Plaza
- Phone Number: 932 53 32 56
- Email: pedrovictorlp@gmail.com
Study Locations
-
-
-
Barcelona, Spain
- Pedro Victor López Plaza
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria :
- State of health with no history of neuromuscular injuries
- Without surgical interventions, or lower limb trauma in the last six months
- No associated cardiovascular disease
- No associated severe COPD.
- AllParticipants are considered untrained if they do not engage in any specific vigorous lower-limb strength training or regularly perform physical exercise or sports activities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: The control group (CG)
he control group (CG) will have the proprioceptive stimulation device placed on the motor points of the quadriceps muscle without the application of deep sensory stimulation throughout the entire evaluation period of Maximum Strength (MS) via Mean Velocity (MV), including rest periods.
|
|
|
Experimental: The Experimental Group 1 (EG1)
The Experimental Group 1 (EG1) will have the device placed on the motor points of the quadriceps muscle with deep peripheral sensory stimulation applied via the device's plungers throughout the entire evaluation period of Maximum Strength (MS) via Mean Velocity (MV), including rest periods.
|
The proprioceptive stimulus will consist of intermittent mechanical pressure on the skin, localized at the neuromuscular motor points of the rectus femoris, vastus lateralis, and vastus medialis of the quadriceps.
The tissue subjected to this precise pressure in areas of high neuromuscular innervation facilitates the stimulation of kinesthetic cortical sensitivity.
The experimental group (EG) will be randomly and crosswise subdivided into two groups, so that both receive the intervention in two different modalities at two different times.
|
|
Experimental: The Experimental Group 2 (EG2)
The Experimental Group 2 (EG2) will have the device placed on the motor points of the quadriceps muscle with deep peripheral sensory stimulation applied via the device's plungers, but only during the rest periods between repetitions in the evaluation process of Maximum Strength (MS) via Mean Velocity (MV), applied continuously for 15 seconds at 20-second intervals over a total of 5 minutes.
|
The proprioceptive stimulus will consist of intermittent mechanical pressure on the skin, localized at the neuromuscular motor points of the rectus femoris, vastus lateralis, and vastus medialis of the quadriceps.
The tissue subjected to this precise pressure in areas of high neuromuscular innervation facilitates the stimulation of kinesthetic cortical sensitivity.
The experimental group (EG) will be randomly and crosswise subdivided into two groups, so that both receive the intervention in two different modalities at two different times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Strength (MS)
Time Frame: estimated time of movement and data collection of 20 minutes
|
The outcome variable will consist of the assessment of Maximum Strength (MS) generated by the participant during the squat movement, from a 90º knee flexion position to full extension measured in two units, kilograms and newtons.
|
estimated time of movement and data collection of 20 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
electric neuromuscular activation
Time Frame: estimated time of movement and data collection of 20 minutes
|
In addition to strength assessment, portable sensors will be placed to digitize kinematics (knee and foot joint angles) and muscle electrical activity (surface electromyography), related to the variable of neuromuscular activation during the squat movement.
|
estimated time of movement and data collection of 20 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
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
- 2025-04-08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Danone NutriciaCompletedHealthy Elderly | Healthy VolunteersChina
-
National and Kapodistrian University of AthensCompletedHealthy Adults | Healthy Volunteers OnlyGreece
Clinical Trials on deep peripheral sensory stimulation
-
Pedro Victor López PlazaNot yet recruiting
-
University of FloridaBoston Scientific CorporationRecruitingParkinson Disease | Deep Brain StimulationUnited States
-
Abbott Medical DevicesTerminatedDepressive Disorder, Major | Unipolar DepressionUnited States, Canada, United Kingdom
-
University of CambridgeKing's College Hospital NHS Trust; Cambridge University Hospitals NHS Foundation...RecruitingAlcohol Use DisorderUnited Kingdom
-
Ali Rezai, MDCompleted
-
Zhiqi MaoRecruitingParkinson's Disease | Executive Function | Electroencephalogram | Functional Near - Infrared SpectroscopyChina
-
University Hospital Inselspital, BerneCompletedMovement Disorder | Urinary Tract DiseaseSwitzerland
-
University of Sao Paulo General HospitalUnknownCerebellar AtaxiaBrazil
-
University of MinnesotaRecruitingParkinson DiseaseUnited States
-
NewronikaTerminatedParkinson DiseaseItaly