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

Julio S. Lora Millán

Status: Enrolling

Conditions: Healthy Subjects or Volunteers; Chronic Stroke

Treatments: Device: Afferent stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07073989

NeuroBot_ESNA_v1

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Healthy subjects

Experimental group

Description:

Intervention applied to healthy subjects

Treatment:

Device: Afferent stimulation

Stroke patients

Experimental group

Description:

Stimulation applied to stroke patients

Treatment:

Device: Afferent stimulation