Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery

NCT ID: NCT06575140

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-18

Study Completion Date

2024-12-31

Brief Summary

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Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. This pilot study investigates whether APS applied during the acute phase of stroke recovery may reduce impairment and improve function in the affected upper extremity.

Detailed Description

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Conditions

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Stroke Stroke, Acute Stroke, Ischemic Stroke, Hemorrhagic Hemiparesis Hemiparesis;Poststroke/CVA Weakness of Extremities as Sequela of Stroke Stroke Sequelae Upper Extremity Paresis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group A

Treatment

Group Type EXPERIMENTAL

Associative Peripheral Stimulation (APS) 1.0

Intervention Type DEVICE

Associative peripheral stimulation paired with rehabilitative exercises.

Group B

Control

Group Type ACTIVE_COMPARATOR

Peripheral Neuromuscular Stimulation

Intervention Type DEVICE

Random peripheral stimulation paired with rehabilitative exercises.

Interventions

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Associative Peripheral Stimulation (APS) 1.0

Associative peripheral stimulation paired with rehabilitative exercises.

Intervention Type DEVICE

Peripheral Neuromuscular Stimulation

Random peripheral stimulation paired with rehabilitative exercises.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Confirmed ischemic or hemorrhagic stroke no earlier than 7 days prior to enrollment;
2. Presentation of hemiparesis or paralysis of the upper extremity due to stroke;
3. Ability to comprehend and follow study instructions;
4. Ability to initiate finger extension (≥3°) at least three times per minute;
5. Fugl-Meyer Assessment (Upper Extremity) score of \<47.

Exclusion Criteria

1. Contraindications, intolerance, or high sensitivity to the experimental protocol;
2. History of upper-extremity disability prior to the index stroke;
3. Neurological conditions (other than stroke) affecting motor function;
4. Treatment of spasticity/increased tone in the affected upper extremity (e.g., with Botox injection);
5. Lack of access to a safe and suitable place of discharge for experimental sessions and follow-up visits.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahmed A. Rahim

OTHER

Sponsor Role lead

Responsible Party

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Ahmed A. Rahim

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Daniel San Juan Orta, MD

Role: STUDY_DIRECTOR

National Institute of Neurology & Neurosurgery

Locations

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General Hospital of Mexico

Mexico City, , Mexico

Site Status RECRUITING

La Raza National Medical Center

Mexico City, , Mexico

Site Status RECRUITING

National Institute of Neurology & Neurosurgery

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Ahmed A Rahim, MTM

Role: CONTACT

+1 (916) 825-8792

Facility Contacts

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Claudia Elisa Alfaro Tapia, MD

Role: primary

Jonathan Isaí Colín Luna, MD

Role: primary

Daniel San Juan Orta, MD

Role: primary

Other Identifiers

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APS-PILOT

Identifier Type: -

Identifier Source: org_study_id

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