StrokeNCT06958185
Effects of Peripheral Somatosensory Stimulation Through Mechanical Pressure on Lower Limb Muscle Strength in Stroke Survivors
A study testing deep peripheral sensory stimulation in people with Stroke, run by Pedro Victor López Plaza at 1 site in Spain.
Trial summary
Somatosensory information is essential for the motor system because when the central nervous system stops receiving afferent signals, it cannot use information about the state of the affected body part to plan or adjust movement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- deep peripheral sensory stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- May 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a diagnosis of unilateral hemispheric stroke (ischemic or hemorrhagic) confirmed by MRI or CT scan.
- At least 3 months must have passed since stroke onset.
- Ability to stand independently in a static position or to walk, regardless of whether assistance is needed.
Who cannot join
- Diagnosis of cognitive, visual, or cardiorespiratory disorder (including the presence of a cardiac pacemaker, heart failure, arrhythmia, or severe COPD)
- Orthopedic intervention in the lower limb
- Balance disorders of vestibular origin
- Skin diseases
- Botulinum toxin treatment within the past year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Somatosensory information is essential for the motor system because when the central nervous system stops receiving afferent signals, it cannot use information about the state of the affected body part to plan or adjust movement. This phenomenon is known as sensory deafferentation, and it significantly affects motor function. This principle offers an opportunity to observe changes in strength through a peripheral proprioceptive stimulus that activates the muscular system with the aim of increasing recruitment. This would justify the implementation of proprioceptive input in approaches focused on motor learning in movement disorders resulting from cortical lesions such as stroke.
Read the detailed description
Objective: o determine whether the application of a peripheral proprioceptive stimulus to the neuromuscular motor points of the quadriceps increases strength and muscle activation during the squat movement in the affected limb of stroke survivors.
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 AVAN Private Foundation Sabadell and Ricard i Fortuny Socio-Healthcare Center (CSSV RiF), Vilafranca.
- Conditions
- Stroke
- Being tested
- deep peripheral sensory stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep peripheral sensory stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| The control group (CG) | No intervention | The 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. |
| The Experimental Group (EG1) | Experimental | 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. Receives: Device: deep peripheral sensory stimulation |
| The Experimental Group (EG2) | Experimental | 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. Receives: Device: deep peripheral sensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Strength (MS)
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.
Measured: estimated time of movement and data collection of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study startMay 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pedro Victor López Plaza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pedro Victor López Plaza, Facultat de ciencies de la Salut Universitat Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958185
- Sponsor's protocol ID
- 2025-04-10
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peripheral Somatosensory Stimulation Through Mechanical Pressure on Lower Limb Muscle Strength in Stroke Survivors
- ClinicalTrials.gov ID
- NCT06958185
- Acronym / sponsor ID
- 2025-04-10
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Pedro Victor López PlazaUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 6 May 2025 (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.
Somatosensory information is essential for the motor system because when the central nervous system stops receiving afferent signals, it cannot use information about the state of the affected body part to plan or adjust movement. This phenomenon is known as sensory deafferentation, and it significantly affects motor function. This principle offers an opportunity to observe changes in strength through a peripheral proprioceptive stimulus that activates the muscular system with the aim of increasing recruitment. This would justify the implementation of proprioceptive input in approaches focused on motor learning in movement disorders resulting from cortical lesions such as stroke.
Detailed description
Objective: o determine whether the application of a peripheral proprioceptive stimulus to the neuromuscular motor points of the quadriceps increases strength and muscle activation during the squat movement in the affected limb of stroke survivors.
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 AVAN Private Foundation Sabadell and Ricard i Fortuny Socio-Healthcare Center (CSSV RiF), Vilafranca.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The control group (CG) | No intervention | –The 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. |
| The Experimental Group (EG1) | Experimental | Device: deep peripheral sensory stimulationThe 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 Experimental Group (EG2) | Experimental | Device: deep peripheral sensory stimulationThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with a diagnosis of unilateral hemispheric stroke (ischemic or hemorrhagic) confirmed by MRI or CT scan.
- At least 3 months must have passed since stroke onset.
- Ability to stand independently in a static position or to walk, regardless of whether assistance is needed.
Key exclusion criteria (5 listed)
- Diagnosis of cognitive, visual, or cardiorespiratory disorder (including the presence of a cardiac pacemaker, heart failure, arrhythmia, or severe COPD)
- Orthopedic intervention in the lower limb
- Balance disorders of vestibular origin
- Skin diseases
- Botulinum toxin treatment within the past year
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 |
|---|---|---|
| deep peripheral sensory stimulationThe 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. | Device | The Experimental Group (EG1), The Experimental Group (EG2) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep peripheral sensory stimulation in people with Stroke, run by Pedro Victor López Plaza at 1 site in Spain.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 May 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro V López Plaza, Director (932 53 32 56, pedrovictorlp@blanquerna.url.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Strength (MS) (time frame: estimated time of movement and data collection of 20 minutes). 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 6 May 2025.