Non-invasive therapy to improve motor function after stroke
Pilot Randomized Controlled Trial Assessing Associative Peripheral Stimulation (APS) for Reduction of Motor Impairment During Acute Period of Stroke Recovery
This study is testing a new non-invasive therapy called Associative Peripheral Stimulation to see if it can help people who have had a stroke improve their arm and hand movement during their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | APS Trial Group Academic / other |
| Locations | 3 sites (Mexico City and 2 other locations) |
| Trial ID | NCT06575140 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the use of Associative Peripheral Stimulation (APS), a non-invasive therapy that combines transcutaneous electrical muscle stimulation with voluntary movement, to aid in stroke rehabilitation. The focus is on patients who have experienced an ischemic or hemorrhagic stroke within the last week and are exhibiting hemiparesis in their upper extremities. The study aims to determine if APS can effectively reduce motor impairment and enhance functional recovery during the acute phase of stroke recovery.
Who should consider this trial
Good fit: Ideal candidates are individuals who have suffered a stroke within the past week and have upper extremity hemiparesis.
Not a fit: Patients with prior upper extremity disabilities or other neurological conditions affecting motor function may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve motor function and rehabilitation outcomes for stroke patients.
How similar studies have performed: While the approach of using APS is relatively novel, similar non-invasive therapies have shown promise in improving rehabilitation outcomes in stroke patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mexico City and 2 other locations
- 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)
Study contacts
- Study coordinator: Ahmed A Rahim, MTM
- Email: ahmed.rahim@alumni.ucsf.edu
- Phone: +1 (916) 825-8792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.