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

NCT ID: NCT07073989

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2025-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy subjects

Intervention applied to healthy subjects

Group Type: EXPERIMENTAL

Afferent stimulation

Intervention Type: DEVICE

Stimulation applied through mechanical vibration or low-intensity electric currents

Stroke patients

Stimulation applied to stroke patients

Group Type: EXPERIMENTAL

Afferent stimulation

Intervention Type: DEVICE

Stimulation applied through mechanical vibration or low-intensity electric currents

Interventions

Afferent stimulation

Stimulation applied through mechanical vibration or low-intensity electric currents

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Julio S. Lora Millán

OTHER

Sponsor Role: lead

Responsible Party

Julio S. Lora Millán

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Universidad Rey Juan Carlos

Móstoles, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Julio S. Lora Millán, PhD in Automation and Robotics

Role: CONTACT

julio.lora@urjc.es

914880000 ext. 4584

Facility Contacts

Julio S Lora Millan, PhD in Automation and Robotics

Role: primary

julio.lora@urjc.es

914884584 ext. 4584

Other Identifiers

NeuroBot_ESNA_v1

Identifier Type: -

Identifier Source: org_study_id