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The Use of Photobiomodulation in the Treatment of Spasticity After Stroke.

Study acronym: DarbarIllora
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2026 to Aug 28, 2026
    v3
  2. Minor Secondary endpoints: details revised at 1 of 6 entriesv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Stroke is a non-progressive and permanent syndrome in adults, with approximately 60% of patients presenting with spastic hemiparesis. Spasticity leads to changes in the physiological pattern of muscle tissue contraction and hemodynamics, and, when left untreated, negatively impacts functionality. Photobiomodulation (PBM) has demonstrated positive effects on tissue regeneration, muscle relaxation, reduction of inflammation, fatigue, and pain relief in various muscular and neurological disorders. Methods: This blinded, randomized, controlled clinical trial aims to evaluate the effects of PBM on triceps surae muscle spasticity in adults with stroke. Forty-two participants with spastic hemiparesis post-stroke will be randomized into two groups: active PBM (850 nm, 200 mW, 4 J/point in the gastrocnemius, 12 points, weekly for 8 weeks) or placebo PBM (same protocol, device switched off). Both groups will receive the institute's standard rehabilitation treatment. Outcomes will be assessed using the Modified Ashworth Scale (MAS), ankle range of motion, presence of pain, amount of antispastic medication in use, contraction strength (by manual examination) muscle oxygenation (by transcutaneous near-infrared spectroscopy), functionality, and the occurrence of adverse events before and after the intervention. At the end of recruitment, comparisons between groups and between time points will be performed and statistically analyzed using a two-way repeated means ANOVA test and the Generalized Estimating Equations (GEE) test. We also foresee a pilot interim analysis when recruitment reaches a size of 10 participants per group. This interim analysis will be performed using a two-way/means ANOVA to assess effect size and recalculate sample size, making adjustments to the design if necessary.
Trial Details
NCT Number NCT07784231
Lead Sponsor University of Nove de Julho
Conditions
(from sponsor)
Stroke, Spasticity, Photobiomodulation, NIRS
Related terms Muscle Spasticity, Stroke
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov