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NCT Number: NCT06575140

Associative Peripheral Stimulation 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Hemiparesis;Poststroke/CVA Hemorrhagic Stroke Ischemic Stroke Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Sequelae Stroke, Acute Stroke, Hemorrhagic Stroke, Ischemic Upper Extremity Paresis Vascular Diseases Weakness of Extremities as Sequela of Stroke

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Mexico, Mexico City, Mexico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Associative Peripheral Stimulation (APS) 1.0

Device

Associative peripheral stimulation paired with rehabilitative exercises.

Peripheral Neuromuscular Stimulation

Device

Random peripheral stimulation paired with rehabilitative exercises.

Primary outcomes

  1. Maximum Average of Range of Motion (ROM)

    Time frame: 5 weeks

    Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes.

  2. Fugl-Meyer Assessment Upper-Extremity (FMA-UE)

    Time frame: 5 weeks

    Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes.

Secondary outcomes

  1. Maximum Average of Range of Motion (ROM)

    Time frame: 3 months

    Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes.

  2. Fugl-Meyer Assessment Upper-Extremity (FMA-UE)

    Time frame: 3 months

    Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes.

  3. Action Research Arm Test (ARAT)

    Time frame: 5 weeks

    Measure of four functional domains: grasp, grip, pinch, and gross arm movement. Scoring Range: 0 to 57. Higher scores indicate better outcomes.

  4. Action Research Arm Test (ARAT)

    Time frame: 3 months

    Measure of four functional domains: grasp, grip, pinch, and gross arm movement. Scoring Range: 0 to 57. Higher scores indicate better outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Rahim, MTM

CONTACT

[email protected]

+1 (916) 825-8792

Sponsors and collaborators

Lead sponsor

Ahmed A. Rahim

Other

Registry information

Official study title

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

Acronym: APS-PILOT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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