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NCT Number: NCT06395272

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CSSV-Rif

Barcelona, Vilafranca Del Penedés, 08720, Spain

Location status: Recruiting

Location contact

Jon Ozaita

CONTACT

[email protected]

About this study

Objective: To assess whether the SURA electrodevice improves relevant aspects of dynamic balance in stroke survivors.

Methods:The design is a prospective longitudinal randomised controlled trial with simple masking by the examiner to be carried out at the facilities of the Ricard i Fortuny Social and Health Centre (CSSV RiF). The first phase of the intervention (device-on rest phases) will consist of the activation of the device on the muscle motor points of the medial belly of the gastrocnemius, soleus and peroneus muscles. The motor points are the site of penetration of the motor nerve fibers and the highest concentration of motor plates in the muscle, which when stimulated produce the maximum effective muscle contraction. The second phase (OFF activity-device phase) consists of carrying out the therapy as the patient had been doing normally in the Neurorehabilitation department at the center at a rate of 3 sessions per week on an outpatient basis according to their individualized needs.

The control group will perform the same activity, but without the device activated during the device-on rest phases and adapted to the needs of each participant in their usual sessions without a standardized protocol.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

SURA

Device

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.

Primary outcomes

  1. The kinematics, kinetics and spatio-temporal parameters of gait.

    Time frame: 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).

Secondary outcomes

  1. Neuromuscular Activation

    Time frame: Start of intervention, at 4 weeks and at completion 8 weeks

    Neuromuscular Activation Myontec surface electromyograph with sensors will collect the electrical activity of the lower limb muscles involved in gait coactivation. (Activation of motor units in milliseconds)

Other outcomes

  1. Maximum isometric force

    Time frame: Start of intervention, at 4 weeks and at completion 8 weeks

    Maximum isometric force Measurement in Newtons of the muscle groups of hip extensors and flexors, hip internal and external rotators, hip abductors and adductors, knee flexors and extensors, dorsiflexors and plantar flexors of the foot, foot inverters and eversors with K-Force Muscle Controller Kinvent manual muscle dynamometry.

Study contacts

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

Pedro Victor López Plaza

CONTACT

[email protected]

932 53 32 56

Sponsors and collaborators

Lead sponsor

Facultat de ciencies de la Salut Universitat Ramon Llull

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 2, 2024
Registry last updated
May 14, 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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