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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395272
• Other study ID #: 2024-04-18
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 5, 2024
• Est. completion date: December 20, 2024

Study information

• Verified date: April 2024
• 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
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 20, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	CSSV-Rif	Barcelona	Vilafranca Del Penedés

Sponsors (1)

Lead Sponsor	Collaborator
Facultat de ciencies de la Salut Universitat Ramon Llull

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum isometric force	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.	Start of intervention, at 4 weeks and at completion 8 weeks
Primary	The kinematics, kinetics and spatio-temporal parameters of gait.	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).	Start of intervention, at 4 weeks and at completion 8 weeks
Secondary	Neuromuscular Activation	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)	Start of intervention, at 4 weeks and at completion 8 weeks