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

Ahmed A. Rahim

Status: Enrolling

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

Treatments: Device: Peripheral Neuromuscular Stimulation; Device: Associative Peripheral Stimulation (APS) 1.0

Study type: Interventional

Funder types: Other

Identifiers

NCT06575140

APS-PILOT

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Group A

Experimental group

Description:

Treatment

Treatment:

Device: Associative Peripheral Stimulation (APS) 1.0

Group B

Active Comparator group

Description:

Control

Treatment:

Device: Peripheral Neuromuscular Stimulation