Effects of Peripheral Somatosensory Stimulation Through Mechanical Pressure on Lower Limb Muscle Strength in Stroke Survivors

NCT06958185 | Not Yet Recruiting

• 1 other identifier: 2025-04-10
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  estimated time of movement and data collection of 20 minutes

Other Outcomes (2)

• electric neuromuscular activation electric neuromuscular activation electric neuromuscular activation

  estimated time of movement and data collection of 20 minutes

• Transfer of body weight support onto the affected limb in relation to the unaffected limb

  estimated time of movement and data collection of 20 minutes

Study Arms (3)

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.

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.

Device: deep peripheral sensory stimulation

Interventions

deep peripheral sensory stimulation DEVICE

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.

The Experimental Group (EG1); The Experimental Group (EG2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pedro Victor López Plaza: lead

Study Sites (1)

Pedro Victor López Plaza

Barcelona, Spain

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Pedro V López Plaza, Director

CONTACT

932 53 32 56; pedrovictorlp@blanquerna.url.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 6, 2025
• Study Start: May 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

ES (1)