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Recruiting NCT06575140

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

No phase Interventional Stroke Stroke, Acute Stroke, Ischemic Stroke, Hemorrhagic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Associative Peripheral Stimulation (APS) 1.0, Peripheral Neuromuscular Stimulation.
Who it may be relevant to
Registry conditions: Stroke, Stroke, Acute, Stroke, Ischemic, Stroke, Hemorrhagic. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device Associative Peripheral Stimulation (APS) 1.0
    Associative peripheral stimulation paired with rehabilitative exercises.
  • Device Peripheral Neuromuscular Stimulation
    Random peripheral stimulation paired with rehabilitative exercises.

Primary outcome measures

  • Maximum Average of Range of Motion (ROM) [Time frame: 5 weeks]
  • Fugl-Meyer Assessment Upper-Extremity (FMA-UE) [Time frame: 5 weeks]
Secondary outcome measures (4)
  • Maximum Average of Range of Motion (ROM) [Time frame: 3 months]
  • Fugl-Meyer Assessment Upper-Extremity (FMA-UE) [Time frame: 3 months]
  • Action Research Arm Test (ARAT) [Time frame: 5 weeks]
  • Action Research Arm Test (ARAT) [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Mexico · 3 centers
  • General Hospital of Mexico — Mexico City
  • La Raza National Medical Center — Mexico City
  • National Institute of Neurology & Neurosurgery — Mexico City

Identifiers

NCT: NCT06575140 · APS-PILOT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗