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

Not Applicable

Recruiting

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

• Registration Number: NCT06575140
• Lead Sponsor: Ahmed A. Rahim

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2019-03-24
• Study Start: 2021-12-18
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Associative Peripheral Stimulation (APS) 1.0	Treatment
Group B	Peripheral Neuromuscular Stimulation	Control

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

La Raza National Medical Center; 🇲🇽 Mexico City, Mexico

General Hospital of Mexico; 🇲🇽 Mexico City, Mexico

National Institute of Neurology & Neurosurgery; 🇲🇽 Mexico City, Mexico