Actively Recruiting
Pilot Randomized Controlled Trial Assessing Associative Peripheral Stimulation (APS) for Reduction of Motor Impairment During Acute Period of Stroke Recovery
Led by Ahmed A. Rahim · Updated on 2024-08-30
20
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess Associative Peripheral Stimulation (APS), a non-invasive therapy combining electrical muscle stimulation with voluntary movement, for helping people recover upper limb function during the acute phase after a stroke. The focus is on reducing motor impairment in patients who have recently experienced ischemic or hemorrhagic stroke and are showing weakness or paralysis in their upper extremity. Participants are randomly assigned to one of two groups: one receiving APS paired with rehabilitative exercises, and a control group receiving random peripheral stimulation paired with similar exercises. The study is conducted under triple masking to ensure unbiased results and compares outcomes over a 5-week and 3-month period. Throughout the study, participants undergo assessments including measurements of upper limb range of motion and the Fugl-Meyer Assessment for upper extremity function. Additional evaluations such as the Action Research Arm Test are also used. The study tracks progress at 5 weeks and 3 months to monitor motor recovery and function improvement, aiming to provide insight into APS's potential role in stroke rehabilitation.
CONDITIONS
Brief Title
Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 less than 47
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive associative peripheral stimulation or peripheral neuromuscular stimulation paired with rehabilitative exercises.
Weekly visits for up to 5 weeks
Duration - Up to 3 months after treatment
Participants are assessed for motor function and range of motion after treatment completion.
1 to 2 visits depending on recovery progress
Trial Site Locations
Total: 3 locations
1
General Hospital of Mexico
Mexico City, Mexico
Actively Recruiting
2
La Raza National Medical Center
Mexico City, Mexico
Actively Recruiting
3
National Institute of Neurology & Neurosurgery
Mexico City, Mexico
Actively Recruiting
Research Team
A
Ahmed A Rahim, MTM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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