Using vibration and low‑intensity electrical pulses to improve arm proprioception after stroke

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

This project tests whether a wearable device that delivers gentle vibrations and low‑intensity electrical pulses can improve arm position and movement sense in people with chronic stroke, with healthy volunteers included for comparison.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universidad Rey Juan Carlos (Academic / other)
• Locations: 1 site (Móstoles, Madrid)
• Trial ID: NCT07073989 on ClinicalTrials.gov

What this trial studies

This interventional study applies afferent stimulation—mechanical vibrations combined with low‑intensity electrical currents—to deliver enhanced proprioceptive feedback to the upper limb. Sessions will compare responses in people with chronic stroke and in healthy volunteers to characterize device effects and baseline sensory function. Eligible stroke participants have chronic ischemic or hemorrhagic stroke with mild‑to‑moderate upper‑limb impairment and sufficient cognition (MMSE >24). Outcome measures will include standardized upper‑limb motor and sensory scores such as the Fugl‑Meyer upper‑limb sections and functional performance tests conducted at Universidad Rey Juan Carlos.

Who should consider this trial

Good fit: Ideal participants are adults with chronic ischemic or hemorrhagic stroke causing hemiparesis and mild‑to‑moderate upper‑limb impairment (Fugl‑Meyer upper‑limb 35–53) with MMSE >24 and the cognitive ability to follow instructions, and healthy volunteers without upper‑limb or neurological conditions for comparison.

Not a fit: Patients with severe upper‑limb impairment, recent upper‑limb surgery, significant cognitive impairment (MMSE ≤24), acute stroke, or other unstable medical/orthopedic conditions are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the device could improve patients' sense of arm position and movement and potentially speed or enhance recovery of upper‑limb function.

How similar studies have performed: Prior small studies using sensory stimulation, vibration, or low‑intensity electrical inputs have shown promising but mixed improvements in proprioception and motor control, so the approach is plausible but not yet definitively proven.

Eligibility criteria

Inclusion Criteria:

* For healthy subjects:

  1. No neurological or orthopedic conditions affecting upper limb movement.
  2. No surgical interventions on the upper limbs within the past 6 months.
  3. General physical condition adequate to perform the session.
  4. Cognitive abilities sufficient to understand and carry out the experimental procedure.
* For stroke survivors:

  1. Ischemic or hemorrhagic stroke resulting in motor impairments in the upper limb.
  2. Chronic stroke condition.
  3. Subjects with sufficient cognitive abilities to follow instructions and actively participate in the therapy.
  4. Mini-Mental State Examination (MMSE) score \> 24.
  5. 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.

Exclusion Criteria:

1. Acute musculoskeletal disorders.
2. Peripheral vascular diseases.
3. Acute cardiopulmonary conditions.
4. Acute neurological disorders.
5. Restricted mobility of upper limb joints due to any cause.
6. Pain as a cause of impaired upper limb mobility.

Where this trial is running

Móstoles, Madrid

• Universidad Rey Juan Carlos — Móstoles, Madrid, Spain (Recruiting)

Study contacts

• Study coordinator: Julio S. Lora Millán, PhD in Automation and Robotics

Conditions Healthy Subjects or Volunteers; Chronic Stroke; Afferent stimulation; Proprioception