Stroke Clinical Trial - Effects of Proprioceptive Sensitivity Stimulation

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06395272
Study type	Interventional
Source	Facultat de ciencies de la Salut Universitat Ramon Llull
Contact	Pedro Victor López Plaza
Phone	932 53 32 56
Email	pedrovictorlp@blanquerna.url.edu
Status	Not yet recruiting
Phase	N/A
Start date	May 5, 2024
Completion date	December 20, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms