Investigating the Impact of Afferent Stimulation on Proprioceptive Function in Post-Stroke Rehabilitation

NCT07073989 | Recruiting

• 1 other identifier: NeuroBot_ESNA_v1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects or Volunteers; Chronic Stroke

Keywords

Afferent stimulation; Proprioception

Outcome Measures

Primary Outcomes (1)

• 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.

  Periprocedural

Study Arms (2)

Healthy subjects

EXPERIMENTAL

Intervention applied to healthy subjects

Device: Afferent stimulation

Stroke patients

EXPERIMENTAL

Stimulation applied to stroke patients

Device: Afferent stimulation

Interventions

Afferent stimulation DEVICE

Stimulation applied through mechanical vibration or low-intensity electric currents

Healthy subjects; Stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:
• : severe impairment
• : moderate-to-severe impairment
• : mild-to-moderate impairment
• : mild impairment 6. Subjects presenting upper limb hypertonia with a score below 3 on the Modified Ashworth Scale.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Julio S. Lora Millán: lead

Study Sites (1)

Universidad Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

RECRUITING

Central Study Contacts

Julio S. Lora Millán, PhD in Automation and Robotics

CONTACT

914880000; julio.lora@urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 20, 2025
• Study Start: June 17, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

ES (1)