StrokeNCT06395272
Effects of Proprioceptive Sensitivity Stimulation Via the SURA Electrodevice on Kinematics, Kinetics and Spatiotemporal Parameters of Gait.
A study testing SURA in people with Stroke, run by Facultat de ciencies de la Salut Universitat Ramon Llull at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- SURA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 24 May 2024to 20 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
CSSV-Rif
Barcelona, Vilafranca Del Penedés, 08720
Jon Ozaita, jon.ozaita@gmail.com
About this study
Official title: Effects of Proprioceptive Sensitivity Stimulation Via the SURA Electrodevice on Kinematics, Kinetics and Spatiotemporal Parameters of Gait: a Pilot Study.
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- SURA
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: SURA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Start of intervention, at 4 weeks and at completion 8 weeks
Secondary outcomes (1)
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)
Measured: Start of intervention, at 4 weeks and at completion 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start24 May 2024
- Primary completionMay 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design is a prospective longitudinal randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Facultat de ciencies de la Salut Universitat Ramon Llull
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395272
- Sponsor's protocol ID
- 2024-04-18
- Status last verified
- May 2025
- First submitted
- 21 Apr 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Sensitivity Stimulation Via the SURA Electrodevice on Kinematics, Kinetics and Spatiotemporal Parameters of Gait: a Pilot Study.
- ClinicalTrials.gov ID
- NCT06395272
- Acronym / sponsor ID
- 2024-04-18
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Facultat de ciencies de la Salut Universitat Ramon LlullUniversity, hospital or other
- Study start
- 24 May 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The design is a prospective longitudinal randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL | Experimental | Device: SURAThe 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. |
| COMPARATOR | Sham comparator | Device: SURAThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SURAThe 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. | Device | COMPARATOR, EXPERIMENTAL |
Primary outcome
The kinematics, kinetics and spatio-temporal parameters of gait.
Time frame: Start of intervention, at 4 weeks and at completion 8 weeks
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).
1 secondary outcome
Neuromuscular Activation
Time frame: Start of intervention, at 4 weeks and at completion 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SURA in people with Stroke, run by Facultat de ciencies de la Salut Universitat Ramon Llull at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro Victor López Plaza (932 53 32 56, pedrovictorlp@blanquerna.url.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The kinematics, kinetics and spatio-temporal parameters of gait. (time frame: Start of intervention, at 4 weeks and at completion 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.