Photobiomodulation to Help Spasticity After Stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this blinded, randomized study, adults with spastic hemiparesis after stroke will receive either active photobiomodulation therapy or a placebo, in addition to their standard rehabilitation. The therapy uses near-infrared light applied to the gastrocnemius with sessions weekly for eight weeks. Outcomes include muscle tone, range of motion, pain, antispastic medication use, muscle oxygenation, and functional status, measured before and after the intervention. Data will be analyzed to compare changes between groups across time points. The study aims to determine if PBM can improve spasticity and related function without added safety concerns.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults who have sustained a unilateral ischemic or hemorrhagic cortical motor stroke, with the diagnosis documented in the acute phase by computed tomography (CT) or magnetic resonance imaging (MRI);
* Patients currently undergoing multidisciplinary rehabilitation at the Rehabilitation Center where the study will be conducted;
* Patients presenting with a motor pattern of spastic hemiparesis secondary to stroke;
* Patients demonstrating the ability to perform orthostatism (standing posture) or therapeutic or functional gait activity.

Exclusion Criteria:

* Presence of uncontrolled systemic diseases, including but not limited to cancer, active infections, or uncontrolled diabetes mellitus;
* History of photosensitivity or known hypersensitivity to light exposure;
* Triceps surae spasticity graded as 4 on the Modified Ashworth Scale (MAS) at the initial pre-screening assessment;Acute clinical instability or any acute medical condition requiring immediate intervention;
* Fixed anatomical deformities of the ankle joint that preclude a minimum passive or active range of motion of at least 60 degrees;
* Malnutrition or significant nutritional deficiencies;Acute clinical conditions with the potential to exacerbate spasticity, such as acute fractures, cutaneous ulcers, or acute infections;Presence of any other movement or tone disorder (e.g., dystonia, chorea, or parkinsonism) that could confound spasticity assessments;
* Exposed tumors or undiagnosed lesions in the area to be irradiated;
* Change in the pharmacological class of antispastic medications during the therapeutic period of the study. Dose adjustments within the same medication class will be permitted and documented;
* Administration of botulinum toxin type A injections into the triceps surae muscle during the study period or within six months prior to study enrollment;
* Discontinuation of the concomitant physical therapy rehabilitation program, even if the participant continues to receive photobiomodulation per the study protocol;
* Occurrence of any adverse event attributable to photobiomodulation;
* Death;
* Withdrawal of informed consent.

Where it's running

• CER II Guarulhos
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Rebeca B Cecatto, MD, Ph.D.
• Email: rebeca.boltes@gmail.com
• Phone: +55 11970842496

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.