Clinical trial NCT06395272: Effects of Proprioceptive Sensitivity Stimulation Via the SURA Electrodevice on Kinematics, Kinetics and Spatiotemporal Parameters of Gait.
Official title: Effects of Proprioceptive Sensitivity Stimulation Via the SURA Electrodevice on Kinematics, Kinetics and Spatiotemporal Parameters of Gait: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Facultat de ciencies de la Salut Universitat Ramon Llull
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design is a prospective longitudinal randomised controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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 outcomes:
measure: The kinematics, kinetics and spatio-temporal parameters of gait.
timeFrame: Start of intervention, at 4 weeks and at completion 8 weeks
Secondary outcomes:
measure: Neuromuscular Activation
timeFrame: Start of intervention, at 4 weeks and at completion 8 weeks
Other outcomes:
measure: Maximum isometric force
timeFrame: Start of intervention, at 4 weeks and at completion 8 weeks
Locations:
city: Barcelona
country: Spain
facility: CSSV-Rif
state: Vilafranca Del Penedés
Study officials:
References: