Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395272
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-21
Brief Title:
Effects of Proprioceptive Sensitivity Stimulation Via the SURA Electrodevice on Kinematics Kinetics and Spatiotemporal Parameters of Gait
Sponsor:
Facultat de ciencies de la Salut Universitat Ramon Llull
Organization:
Facultat de ciencies de la Salut Universitat Ramon Llull
Study Overview
Official Title:
Effects of Proprioceptive Sensitivity Stimulation Via the SURA Electrodevice on Kinematics Kinetics and Spatiotemporal Parameters of Gait a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Objective To assess whether the SURA electrodevice improves relevant aspects of dynamic balance in stroke survivors
MethodsThe 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
MethodsThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None