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EARLY BOT-SPASNCT06811142

Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence

StatusNot Yet Recruiting
PhaseEarly Phase 1
Primary completion (estimated)
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Record History

All 3 versions: 2 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Start date: Jan 28, 2025 to Dec 1, 2026 Show 5 more changesShow less
    • Trial status changed: Active, Not Recruiting → Not Yet Recruiting
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Site details revised
    • Publications: details revised at 13 of 16 entries
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Modified Ashworth Scale
Timeframe: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
MODIFIED TARDIEU SCALE
Timeframe: Baseline (within 7 days post-stroke) 8 weeks post-intervention 12 weeks post-intervention 6 months post-intervention 12 months post-intervention

Secondary (7)

MINI MENTAL STATE EXAMINATION
BARTHEL INDEX
NIHSS SCALE
Modified Rankin Scale
Fugl-Meyer Upper and Lower Extremity Scale
Show 2 moreShow less
Goal Attainment Scaling
MEDICAL RESEARCH COUNCIL

Arms and interventions

interventionActive comparator

Participants in the intervention group will receive early botulinum toxin type A (BoNT-A) injections in addition to a standard rehabilitation program. The botulinum toxin will be administered within the first 12 weeks following stroke onset, targeting muscles affected by spasticity. The injections aim to reduce abnormal muscle tone, prevent contractures, and improve functional mobility. Rehabilitation therapy will include physical exercises, range-of-motion activities, and muscle-strengthening interventions tailored to individual recovery needs. The combined therapy is designed to optimize motor function, promote neuroplasticity, and improve overall independence and quality of life.

controlNo intervention

Participants in the control group will undergo a standard rehabilitation program without the early application of botulinum toxin. The rehabilitation will consist of physical therapy focused on improving muscle strength, range of motion, and functional independence. Treatment will be tailored to each participant's condition and recovery progress, following established post-stroke rehabilitation protocols. This group will serve as the comparator to evaluate the additional benefits of early botulinum toxin intervention.

Drugs: Botulinum Toxin Type A (BoNT-A)

Sites

1 site in 1 country

  • Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.Mérida, Yucatán, Mexico