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

NCT06395272 | Recruiting DMC

• 1 other identifier: 2024-04-18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neuromuscular Activation

  Start of intervention, at 4 weeks and at completion 8 weeks

Other Outcomes (1)

• Maximum isometric force

  Start of intervention, at 4 weeks and at completion 8 weeks

Study Arms (2)

EXPERIMENTAL

EXPERIMENTAL

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 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.

Device: SURA

COMPARATOR

SHAM COMPARATOR

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 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.

Device: SURA

Interventions

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.

COMPARATOR; EXPERIMENTAL

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Facultat de ciencies de la Salut Universitat Ramon Llull: lead

Study Sites (1)

CSSV-Rif

Barcelona, Vilafranca Del Penedés, 08720, Spain

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Pedro Victor López Plaza

CONTACT

932 53 32 56; pedrovictorlp@blanquerna.url.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The design is a prospective longitudinal randomised controlled trial

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: May 2, 2024
• Study Start: May 24, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 20, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)