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

This study examines the early use of botulinum toxin in patients recovering from their first stroke to help reduce muscle stiffness and improve mobility. Spasticity, a condition that causes abnormal muscle tightness, is a common complication following strokes. It can result in decreased independence, pain, joint contractures, and difficulty performing daily activities. Early intervention is critical to prevent long-term complications and improve recovery outcomes.The participants are men and women aged 18 and older who have recently experienced their first stroke. These patients, admitted to the Regional General Hospital No. 1 "Lic. Ignacio García Téllez" in Mérida, Yucatán, will receive botulinum toxin injections alongside a comprehensive rehabilitation program. Botulinum toxin, commonly known for its muscle-relaxing effects, will be administered within the first three months after the stroke. This early timeline aims to maximize recovery by addressing muscle tightness before it worsens.The study will evaluate how the combination of botulinum toxin and physical therapy affects muscle tone, functional independence, and overall quality of life. Key measurements include the Modified Ashworth Scale (MAS) to assess muscle stiffness, the Barthel Index to evaluate daily activity independence, and cognitive assessments to monitor brain recovery. Patients' progress will be tracked over several months to measure the intervention's short, medium, and long-term impact.Previous research suggests that early application of botulinum toxin can prevent long-lasting muscle contractures and improve mobility, but more studies are needed to confirm its benefits in stroke rehabilitation. The results of this research could help establish early botulinum toxin injections as a standard practice in stroke recovery programs, reducing disability and healthcare costs while improving the lives of stroke survivors.

This clinical study evaluates the impact of early application of botulinum toxin on patients experiencing their first cerebrovascular event. Spasticity, characterized by abnormal muscle stiffness and involuntary muscle contractions, is a frequent complication of strokes that can lead to reduced mobility, pain, joint deformities, and a diminished ability to perform daily activities. The study aims to determine whether early intervention with botulinum toxin, in combination with rehabilitation therapy, can mitigate the development and severity of post-stroke spasticity, improve muscle tone, and enhance functional outcomes.

Patients eligible for participation include men and women aged 18 and older, admitted with a confirmed diagnosis of a recent stroke within the first seven days of symptom onset. The intervention will involve botulinum toxin injections administered within the early subacute phase (up to 12 weeks post-stroke) to maximize the neuroplastic window and reduce the risk of permanent muscle contractures. The study will be conducted over three years at the Regional General Hospital No. 1 "Lic. Ignacio García Téllez," Mérida, Yucatán.

The primary outcomes assessed will include changes in muscle tone, evaluated by the Modified Ashworth Scale (MAS), and functional independence, measured using the Barthel Index. Secondary outcomes will assess quality of life, cognitive performance, and overall rehabilitation progress through tools such as the Mini-Mental State Examination (MMSE) and the Fugl-Meyer Assessment Scale. The study design is a prospective, controlled clinical trial comparing patients receiving early botulinum toxin injections with those undergoing standard rehabilitation only.

This research aims to provide valuable clinical evidence regarding the effectiveness of early botulinum toxin application in preventing long-term disabilities, enhancing recovery, and reducing healthcare burdens associated with post-stroke spasticity. By identifying clinical predictors of spasticity, the study will contribute to the development of targeted, time-sensitive interventions that optimize stroke rehabilitation outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years old. Beneficiaries treated in the Emergency and/or Internal Medicine service at HGR No. 1, IMSS Mérida, Yucatán, with an acute stroke confirmed by clinical symptoms and a new ischemic lesion detected through magnetic resonance imaging or computed tomography within 7 days of onset.

Exclusion Criteria:

* Severe cognitive deficits.

  * Severe language comprehension disorders.
  * Lack of capacity to give informed consent.
  * Physical disability already existing before the acute stroke.
  * Subarachnoid hemorrhage.
  * Transient ischemic attack.
  * Any other neurological disorder that could affect muscle tone (Conditions related to the spine, brain infection and traumatic brain injury).
  * Any amputation of the limb on the affected side.
  * Peripheral neuropathy of the upper and/or lower limbs.
  * Patients who have suffered a previous stroke.