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

Ahmed A. Rahim20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Stroke Stroke, Acute Stroke, Ischemic Stroke, Hemorrhagic Hemiparesis Hemiparesis;Poststroke/CVA

Interventions

Associative Peripheral Stimulation (APS) 1.0DEVICE

Associative peripheral stimulation paired with rehabilitative exercises.

Peripheral Neuromuscular StimulationDEVICE

Random peripheral stimulation paired with rehabilitative exercises.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (3)

General Hospital of Mexico

Mexico City, Mexico

RECRUITING

La Raza National Medical Center

Mexico City, Mexico

RECRUITING

National Institute of Neurology & Neurosurgery

Mexico City, Mexico

RECRUITING

Outcomes

Primary Outcomes

Maximum Average of Range of Motion (ROM)

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

Time frame: 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.

Time frame: 5 weeks

Secondary Outcomes

Maximum Average of Range of Motion (ROM)

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 3 months

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts