StrokePhase 1/2DarbarIlloraNCT07784231
The Use of Photobiomodulation in the Treatment of Spasticity After Stroke.
A Phase 1/2 study testing Photobiomodulation Therapy and Standard Multidisciplinary Rehabilitation Program for Spasticity in people with Stroke and Spasticity, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Spasticity, Photobiomodulation
- What is being tested?
- Photobiomodulation Therapy and Standard Multidisciplinary Rehabilitation Program for Spasticity
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Aug 2026to 30 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
CER II Guarulhos
São Paulo, São Paulo, 05020-000
Rebeca Cecatto, PhD, MD, 11970842496, rebeca.boltes@gmail.com
About this study
Official title: The Use of Photobiomodulation in the Treatment of Spasticity After Stroke: a Blinded Clinical Trial.
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.
Read the detailed description
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.
- Conditions
- Stroke, Spasticity, Photobiomodulation, NIRS
- Being tested
- Photobiomodulation Therapy, Placebo PBM, Standard Multidisciplinary Rehabilitation Program for Spasticity
- Keywords
- stroke, photobiomodulation, spasticity, NIRS
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation TherapyRadiation
Also called Low level Laser Therapy
Photobiomodulation (PBM)-formerly referred to as low-level laser therapy (LLLT) or cold laser therapy-is a non-invasive, non-thermal therapeutic modality that employs light in the red to near-infrared spectrum (typically spanning wavelengths from approximately 600 nm to 1,100 nm) to elicit beneficial biological responses in target tissues. The underlying mechanism of action is primarily photochemical rather than photothermal: photons delivered to the tissue are absorbed by endogenous chromophores, most notably cytochrome *c* oxidase (CCO), a key enzyme in the mitochondrial electron transport chain. This absorption transiently increases mitochondrial membrane potential, augments adenosine triphosphate (ATP) synthesis, and modulates the generation of reactive oxygen species (ROS). These primary mitochondrial events subsequently trigger a cascade of secondary intracellular signaling pathways-including the activation of transcription factors such as nuclear factor kappa-B (NF-κB) and hypox
Placebo PBMRadiation
Application of transcutaneous PBM therapy - device switched off- to the gastrocnemius muscles
Standard Multidisciplinary Rehabilitation Program for SpasticityOther
A comprehensive, multidisciplinary intervention delivered by a specialized team-including physical therapists and rehabilitation physicians-who collaboratively develop an individualized treatment plan tailored to each patient's functional deficits, baseline mobility, and specific spasticity profile. The physical therapy component emphasizes a combination of passive and active stretching protocols, therapeutic exercise to strengthen agonist muscles and improve motor control, gait and balance training, and adjunctive modalities such as neuromuscular electrical stimulation or therapeutic ultrasound, all administered at a frequency and intensity commensurate with the patient's tolerance and clinical progression. Concurrently, the multidisciplinary team addresses associated impairments through therapy focused on activities of daily living and limb function, pharmacological management with oral or antispastics injections as indicated
| Study group | Role | What they receive |
|---|---|---|
| PBM group | Experimental | Application of transcutaneous PBM therapy to the gastrocnemius muscles of the hemiparetic limb associated with standardized rehabilitation therapies according to the institution's protocol Receives: Radiation: Photobiomodulation Therapy; Other: Standard Multidisciplinary Rehabilitation Program for Spasticity |
| Placebo | Placebo comparator | Application of transcutaneous PBM therapy - device switched off- to the gastrocnemius muscles of the hemiparetic limb associated with standardized rehabilitation therapies according to the institution's protocol Receives: Radiation: Placebo PBM; Other: Standard Multidisciplinary Rehabilitation Program for Spasticity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity Grade
The change in triceps surae spasticity severity, assessed using the Modified Ashworth Scale (MAS). The MAS is a widely validated, clinician-rated ordinal scale that quantifies muscle hypertonia by measuring the resistance encountered during passive joint mobilization; it grades spasticity from 0 (no increase in muscle tone) through 4 (affected part rigid in flexion or extension), with intermediate scores of 1, 1+, 2, and 3 denoting progressively greater degrees of resistance and catch phenomena throughout the range of motion.
Measured: Baseline" or "Day 1" and * through study completion, an average of 8 weeks. It will also be assessed immediately before and after each PBM session.
Spasticity Grade
Quantity of antispastic medications used. Information regarding the medications (class, quantity, dose, and route of administration) used by participants for the treatment of spasticity before and after the end of the 8-week therapeutic period will be collected from medical records.
Measured: Baseline" or "Day 1" and * through study completion, an average of 8 weeks.
Secondary outcomes (6)
Pain Intensity
The presence of pain in the cutaneous reference region of the triceps surae will be assessed using a Numerical Pain Scale (NPS) / The NPS is an aid in measuring the intensity of pain felt by the patient, an important instrument to verify progress and analyze the treatment instituted. The participant should be asked about their level of pain, where 0 means total absence of pain and 10 the maximum pain level.
Measured: Baseline" or "Day 1" , and immediately before and after each weekly PBM session and through study completion, an average of 8 weeks
Active and Passive Ankle Range of Motion
Active and passive range of motion (ROM) of the ankle joint on the affected hemibody will be assessed using standard goniometry. Goniometric measurement is a reliable and widely accepted clinical method for quantifying joint mobility, performed with a universal goniometer aligned to the anatomical landmarks of the ankle joint complex. Active ROM will be measured with the participant performing the ankle movement independently through the available range, whereas passive ROM will be measured with the examiner passively mobilizing the joint through its full available range of motion, ensuring that no excessive force is applied (McRae, 2011). This outcome provides an objective indicator of joint mobility impairment and allows for the evaluation of treatment-related changes in musculoskeletal restriction secondary to spasticity.
Measured: Baseline" or "Day 1" and * through study completion, an average of 8 weeks
Functional Independence
Functional status will be assessed using the Functional Independence Measure (FIM) is an 18-item, 7-point ordinal scale that evaluates the level of assistance required for activities of daily living across motor and cognitive domains, with higher scores indicating greater independence .
Measured: Baseline" or "Day 1" and * through study completion, an average of 8 weeks
Motor recovery
the lower-extremity motor subscale of the Fugl-Meyer Assessment (FMA-LE) will be employed to evaluate sensorimotor recovery, focusing on volitional movement, coordination, and reflex activity of the affected lower limb; this scale is scored on a 3-point ordinal system (0 = no performance, 1 = partial performance, 2 = full performance), with higher scores reflecting better motor function (Shim, 2025).
Measured: Baseline" or "Day 1" and * through study completion, an average of 8 weeks
Oxygenation of the Gastrocnemius Muscles
To assess the oxygenation of the gastrocnemius muscles in real time, a non-invasive transcutaneous muscle oxygen sensor using near-infrared spectroscopy will be employed
Measured: Baseline" or "Day 1" , on fifth PBM session, and * through study completion, an average of 8 weeks
Contraction force of the triceps surae
Triceps surae muscle strength manual test (Polkey, 1977) MRC
Measured: Baseline" or "Day 1" and * through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start28 Aug 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebeca Boltes Cecatto, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784231
- Sponsor's protocol ID
- DarbarIllora
- Acronym
- DarbarIllora
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Photobiomodulation in the Treatment of Spasticity After Stroke: a Blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT07784231
- Acronym / sponsor ID
- DarbarIllora / DarbarIllora
- Conditions
- Stroke, Spasticity, Photobiomodulation, NIRS
- Keywords
- stroke, photobiomodulation, spasticity, NIRS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM group | Experimental | Radiation: Photobiomodulation Therapy, Other: Standard Multidisciplinary Rehabilitation Program for SpasticityApplication of transcutaneous PBM therapy to the gastrocnemius muscles of the hemiparetic limb associated with standardized rehabilitation therapies according to the institution's protocol |
| Placebo | Placebo comparator | Radiation: Placebo PBM, Other: Standard Multidisciplinary Rehabilitation Program for SpasticityApplication of transcutaneous PBM therapy - device switched off- to the gastrocnemius muscles of the hemiparetic limb associated with standardized rehabilitation therapies according to the institution's protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation TherapyAlso: Low level Laser TherapyPhotobiomodulation (PBM)-formerly referred to as low-level laser therapy (LLLT) or cold laser therapy-is a non-invasive, non-thermal therapeutic modality that employs light in the red to near-infrared spectrum (typically spanning wavelengths from approximately 600 nm to 1,100 nm) to elicit beneficial biological responses in target tissues. The underlying mechanism of action is primarily photochemical rather than photothermal: photons delivered to the tissue are absorbed by endogenous chromophores, most notably cytochrome *c* oxidase (CCO), a key enzyme in the mitochondrial electron transport chain. This absorption transiently increases mitochondrial membrane potential, augments adenosine triphosphate (ATP) synthesis, and modulates the generation of reactive oxygen species (ROS). These primary mitochondrial events subsequently trigger a cascade of secondary intracellular signaling pathways-including the activation of transcription factors such as nuclear factor kappa-B (NF-κB) and hypox | Radiation | PBM group |
| Placebo PBMApplication of transcutaneous PBM therapy - device switched off- to the gastrocnemius muscles | Radiation | Placebo |
| Standard Multidisciplinary Rehabilitation Program for SpasticityA comprehensive, multidisciplinary intervention delivered by a specialized team-including physical therapists and rehabilitation physicians-who collaboratively develop an individualized treatment plan tailored to each patient's functional deficits, baseline mobility, and specific spasticity profile. The physical therapy component emphasizes a combination of passive and active stretching protocols, therapeutic exercise to strengthen agonist muscles and improve motor control, gait and balance training, and adjunctive modalities such as neuromuscular electrical stimulation or therapeutic ultrasound, all administered at a frequency and intensity commensurate with the patient's tolerance and clinical progression. Concurrently, the multidisciplinary team addresses associated impairments through therapy focused on activities of daily living and limb function, pharmacological management with oral or antispastics injections as indicated | Other | PBM group, Placebo |
Primary outcome
Spasticity Grade
Time frame: Baseline" or "Day 1" and * through study completion, an average of 8 weeks. It will also be assessed immediately before and after each PBM session.
The change in triceps surae spasticity severity, assessed using the Modified Ashworth Scale (MAS). The MAS is a widely validated, clinician-rated ordinal scale that quantifies muscle hypertonia by measuring the resistance encountered during passive joint mobilization; it grades spasticity from 0 (no increase in muscle tone) through 4 (affected part rigid in flexion or extension), with intermediate scores of 1, 1+, 2, and 3 denoting progressively greater degrees of resistance and catch phenomena throughout the range of motion.
Spasticity Grade
Time frame: Baseline" or "Day 1" and * through study completion, an average of 8 weeks.
Quantity of antispastic medications used. Information regarding the medications (class, quantity, dose, and route of administration) used by participants for the treatment of spasticity before and after the end of the 8-week therapeutic period will be collected from medical records.
6 secondary outcomes
Pain Intensity
Time frame: Baseline" or "Day 1" , and immediately before and after each weekly PBM session and through study completion, an average of 8 weeks
Active and Passive Ankle Range of Motion
Time frame: Baseline" or "Day 1" and * through study completion, an average of 8 weeks
Functional Independence
Time frame: Baseline" or "Day 1" and * through study completion, an average of 8 weeks
Motor recovery
Time frame: Baseline" or "Day 1" and * through study completion, an average of 8 weeks
Oxygenation of the Gastrocnemius Muscles
Time frame: Baseline" or "Day 1" , on fifth PBM session, and * through study completion, an average of 8 weeks
Contraction force of the triceps surae
Time frame: Baseline" or "Day 1" and * through study completion, an average of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Photobiomodulation Therapy and Standard Multidisciplinary Rehabilitation Program for Spasticity in people with Stroke and Spasticity, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebeca B Cecatto, MD, Ph.D. (+55 11970842496, rebeca.boltes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity Grade (time frame: Baseline" or "Day 1" and * through study completion, an average of 8 weeks. It will also be assessed immediately before and after each PBM session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.