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NCT Number: NCT06958185

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pedro Victor López Plaza

Barcelona, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Other outcomes

  1. electric neuromuscular activation electric neuromuscular activation 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 the electrical activity (surface electromyography), related to the variable of neuromuscular activation during the squat movement.

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

    Time frame: estimated time of movement and data collection of 20 minutes

    Pressure insoles, one on each foot, to record plantar pressure distribution and obtain ground reaction forces.

Study contacts

Contact information is provided by the study sponsor or research team.

Pedro V López Plaza, Director

CONTACT

[email protected]

932 53 32 56

Sponsors and collaborators

Lead sponsor

Pedro Victor López Plaza

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 6, 2025
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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