Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery (APS-PILOT)

Pilot Randomized Controlled Trial Assessing Associative Peripheral Stimulation (APS) for Reduction of Motor Impairment During Acute Period of Stroke Recovery

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Stroke, Ischemic; Stroke, Acute; Stroke Sequelae; Hemiparesis; Upper Extremity Paresis; Hemiparesis;Poststroke/CVA; Weakness of Extremities as Sequela of Stroke; Stroke, Hemorrhagic
• Intervention / Treatment: Device: Associative Peripheral Stimulation (APS) 1.0; Device: Peripheral Neuromuscular Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed A Rahim, MTM; Phone Number: +1 (916) 825-8792; Email: ahmed.rahim@alumni.ucsf.edu

Study Locations

• Mexico
  • Mexico City, Mexico
    • Recruiting
    • General Hospital of Mexico
    • Contact: Claudia Elisa Alfaro Tapia, MD
  • Mexico City, Mexico
    • Recruiting
    • La Raza National Medical Center
    • Contact: Jonathan Isaí Colín Luna, MD
  • Mexico City, Mexico
    • Recruiting
    • National Institute of Neurology & Neurosurgery
    • Contact: Daniel San Juan Orta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Treatment	Device: Associative Peripheral Stimulation (APS) 1.0; Associative peripheral stimulation paired with rehabilitative exercises.
Active Comparator: Group B; Control	Device: Peripheral Neuromuscular Stimulation; Random peripheral stimulation paired with rehabilitative exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Average of Range of Motion (ROM)	Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes.	5 weeks
Fugl-Meyer Assessment Upper-Extremity (FMA-UE)	Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Average of Range of Motion (ROM)	Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes.	3 months
Fugl-Meyer Assessment Upper-Extremity (FMA-UE)	Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes.	3 months
Action Research Arm Test (ARAT)	Measure of four functional domains: grasp, grip, pinch, and gross arm movement. Scoring Range: 0 to 57. Higher scores indicate better outcomes.	5 weeks
Action Research Arm Test (ARAT)	Measure of four functional domains: grasp, grip, pinch, and gross arm movement. Scoring Range: 0 to 57. Higher scores indicate better outcomes.	3 months

Collaborators and Investigators

• Sponsor: Ahmed A. Rahim
• Investigators: Study Director: Daniel San Juan Orta, MD, National Institute of Neurology & Neurosurgery

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 24, 2019
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Stroke Rehabilitation; Associative Peripheral Stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Ischemic Stroke; Hemorrhagic Stroke; Paresis
• Other Study ID Numbers: APS-PILOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data shall not be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes