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Clinical Trials in Spain / NCT06395272
Recruiting Not applicable

Effects of Proprioceptive Sensitivity Stimulation Via the SURA Electrodevice on Kinematics, Kinetics and Spatiotemporal Parameters of Gait.

NCT06395272 · tracked via the Priya Life Science Spain tracker
Sponsor
Facultat de ciencies de la Salut Universitat Ramon Llull
Phase
Not applicable
Started
2024-05-24
Last updated
2025-05-14

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

SURA

SURA: The motor points are the site of penetration of the motor nerve fibres and the highest concentration of motor plates in the muscle, which when stimulated produce the maximum effective muscle contraction. For 15 minutes and in a comfortable seated position at 90° hip, knee and foot, sustained pressure of 30 seconds each shall be exerted through the output plunger of the proprioceptive stimulus device.

Study summary

Recovery of function in people with central nervous system (CNS) injury after stroke is very much like a relearning process that takes advantage of preserved sensorimotor circuits. Relearning can be optimised by providing appropriate proprioceptive (or deep sensory) information to the spinal cord with the aim of maximally engaging the preserved neural circuits. The development of the SURA electrodevice offers this sensitive input mechanism, within the Botton Up therapies. And through research on its use, the impact on the different dimensions related to gait and its components, and the translation to the functional reality of the person, will be evaluated.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Unilateral hemispheric stroke (ischaemic or haemorrhagic) diagnosed by MRI or CT scan, at least 3 months after onset of stroke * Ability to walk at least 10m (irrespective of the need for assistance) * Weakness in ankle dorsiflexion of the paretic limb (TFM\>3) * Ankle ROM \>30° and 0° of foot dorsiflexion in knee extension * Age between 18 and 85 years * Mini-Mental State Examination (MMSE) \> 24 score, non-disabling cognitive impairment * Presence of clonus and hyperresistance to passive joint movement. Exclusion Criteria: * Diagnosis of Cognitive, visual or cardiorespiratory disorder (including cardiac pacemaker placement, heart failure and arrhythmia) * Orthopaedic intervention for IE * Balance disorders with vestibular features * Skin diseases * Botulinum toxin treatment within the last year. * In addition, subjects who had participated in other studies in the last six months that could interact with the current study will be excluded.

Primary outcome measure(s)

  • The kinematics, kinetics and spatio-temporal parameters of gait. — Start of intervention, at 4 weeks and at completion 8 weeks
    An instrumented gait analysis will be performed to obtain a set of spatiotemporal, kinematic and kinetic measurements.The movement will be captured by the Ephion Vitality system. The system consists of two pressure templates and seven inertial sensors (measuring linear acceleration, angular velocity and magnetic field in all three dimensions).

Trial sites (1)

FacilityCityRegionStatus
CSSV-Rif Barcelona Vilafranca Del Penedés Recruiting

More Facultat de ciencies de la Salut Universitat Ramon Llull trials in Spain

Effects of Peripheral Somatosensory Stimulation Via Mechanical Pressure on Lower Limb Muscle Strength in Healthy Subjects. Starting soon
Cortical Effects of Peripheral Proprioceptive Stimulation on the Motor Evoked Potentials of the Limbs Starting soon
Study of the Effect of Peripheral Somatosensory Stimulation on the Functionality of Patients With Cerebral Palsy and Reduced Mobility Recruiting

Other trials for the same condition

Immersive Functional Virtual Reality in People With Acquired Brain Injury and Unilateral Spatial Neglect Starting soon
Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity Recruiting
Effects of Peripheral Somatosensory Stimulation Through Mechanical Pressure on Lower Limb Muscle Strength in Stroke Survivors Starting soon
Stroke Thrombectomy and Aneurysm Registry Recruiting
Effectiveness of an mHealth Intervention, Based on Rehabilitation and a Personalised Nutrition Plan, in the Recovery and Improvement of Dysphagia in Patients Diagnosed With Stroke Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06395272 on ClinicalTrials.gov ↗ ← All trials in Spain