Healthy Subjects or VolunteersNCT07073989
Investigating the Impact of Afferent Stimulation on Proprioceptive Function in Post-Stroke Rehabilitation
A study testing Afferent stimulation in people with Healthy Subjects or Volunteers and Chronic Stroke, run by Julio S. Lora Millán at 1 site in Spain.
Trial summary
The objective of this study is to assess the functionality of a sensory stimulation device that uses mechanical vibrations and low-intensity electrical currents to deliver proprioceptive feedback to stroke patients regarding their movements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects or Volunteers, Chronic Stroke
- What is being tested?
- Afferent stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jun 2025to Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For healthy subjects:
- No neurological or orthopedic conditions affecting upper limb movement.
- No surgical interventions on the upper limbs within the past 6 months.
- General physical condition adequate to perform the session.
- Cognitive abilities sufficient to understand and carry out the experimental procedure.
- For stroke survivors:
Show all 16Show fewer
- Ischemic or hemorrhagic stroke resulting in motor impairments in the upper limb.
- Chronic stroke condition.
- Subjects with sufficient cognitive abilities to follow instructions and actively participate in the therapy.
- Mini-Mental State Examination (MMSE) score > 24.
- Subjects presenting hemiparesis and mild-to-moderate impairment in the upper limb (score on the Fugl-Meyer Motor Assessment for the upper limb, sections A-D, between 35 and 53 points). The maximum score on the FM scale is 66, with the following severity classifications:
- 0-15: severe impairment
- 16-34: moderate-to-severe impairment
- 35-53: mild-to-moderate impairment
- 54-66: mild impairment 6. Subjects presenting upper limb hypertonia with a score below 3 on the Modified Ashworth Scale.
- 7. Subjects who have signed the informed consent document to voluntarily participate in the experiments.
Who cannot join
- Acute musculoskeletal disorders.
- Peripheral vascular diseases.
- Acute cardiopulmonary conditions.
- Acute neurological disorders.
- Restricted mobility of upper limb joints due to any cause.
- Pain as a cause of impaired upper limb mobility.
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
Universidad Rey Juan Carlos
Móstoles, Madrid, 28933
Julio S Lora Millan, PhD in Automation and Robotics, 914884584 ext. 4584, julio.lora@urjc.es
About this study
The objective of this study is to assess the functionality of a sensory stimulation device that uses mechanical vibrations and low-intensity electrical currents to deliver proprioceptive feedback to stroke patients regarding their movements.
- Conditions
- Healthy Subjects or Volunteers, Chronic Stroke
- Being tested
- Afferent stimulation
- Keywords
- Afferent stimulation, Proprioception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afferent stimulationDevice
Stimulation applied through mechanical vibration or low-intensity electric currents
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Intervention applied to healthy subjects Receives: Device: Afferent stimulation |
| Stroke patients | Experimental | Stimulation applied to stroke patients Receives: Device: Afferent stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor illusion
Motor illusion is evaluated by instructing the patient to replicate the movement they experienced in the contralateral limb. Inertial sensors will be placed in such limb to acquire the movement performed by the subject.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start17 Jun 2025
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects or VolunteersStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julio S. Lora Millán
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julio S. Lora Millán, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073989
- Sponsor's protocol ID
- NeuroBot_ESNA_v1
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Afferent Stimulation on Proprioceptive Function in Post-Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT07073989
- Acronym / sponsor ID
- NeuroBot_ESNA_v1
- Conditions
- Healthy Subjects or Volunteers, Chronic Stroke
- Keywords
- Afferent stimulation, Proprioception
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Julio S. Lora MillánUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 20 Jul 2025 (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.
The objective of this study is to assess the functionality of a sensory stimulation device that uses mechanical vibrations and low-intensity electrical currents to deliver proprioceptive feedback to stroke patients regarding their movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Device: Afferent stimulationIntervention applied to healthy subjects |
| Stroke patients | Experimental | Device: Afferent stimulationStimulation applied to stroke patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- For healthy subjects:
- For stroke survivors:
- 0-15: severe impairment
- 16-34: moderate-to-severe impairment
- 35-53: mild-to-moderate impairment
Key exclusion criteria (6 listed)
- Acute musculoskeletal disorders.
- Peripheral vascular diseases.
- Acute cardiopulmonary conditions.
- Acute neurological disorders.
- Restricted mobility of upper limb joints due to any cause.
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 |
|---|---|---|
| Afferent stimulationStimulation applied through mechanical vibration or low-intensity electric currents | Device | Healthy subjects, Stroke patients |
Primary outcome
Motor illusion
Time frame: Periprocedural
Motor illusion is evaluated by instructing the patient to replicate the movement they experienced in the contralateral limb. Inertial sensors will be placed in such limb to acquire the movement performed by the subject.
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 20 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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 Afferent stimulation in people with Healthy Subjects or Volunteers and Chronic Stroke, run by Julio S. Lora Millán 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 16 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 20 Jul 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. 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 Julio S. Lora Millán, PhD in Automation and Robotics (914880000 ext. 4584, julio.lora@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor illusion (time frame: Periprocedural). 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 20 Jul 2025.