Muscle SpasticityPhase 2/3NCT06536751
Therapeutic Photobiomodulation and Tretament of Spasticity
A Phase 2/3 study testing Photobiomodulation and Institution's Standard Physiotherapy in people with Muscle Spasticity and Cerebral Palsy, run by University of Nove de Julho at 2 sites in Brazil.
Trial summary
Cerebral palsy is a non-progressive, permanent syndrome that occurs in childhood and is accompanied by motor, tônus and posture disorders. Its etiology is related to an insult or damage to the central nervous system in maturation. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Muscle Spasticity, Cerebral Palsy, Photobiomodulation
- What is being tested?
- Photobiomodulation and Institution's Standard Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesBrazil
- Study dates
- 15 Aug 2023to 31 Dec 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with diagnosis of spastic cerebral palsy affecting inferior limbs from any etiology;
- Cerebral palsy duration at least 03 months;
- Patients ongoing physiotherapy treatment at University.
Who cannot join
- Patients with fixed anatomical deformities of the ankle that do not allow ankle joint movement of at least 90 degrees of amplitude;
- Patients with malnutrition;
- Patients who present acute clinical conditions with potential for increase spasticity such as acute fractures, skin ulcers, acute infections;
- Patients with severe gastroesophageal reflux disease;
- Patients with another type of movement or tone disorder;
- Patients who have exposed tumors in the area to be irradiated;
Show all 9Show fewer
- Patients with a history of photosensitivity to photonic or light therapy;
- Patients who have undiagnosed lesions in the treatment region;
- Patients using topical photosensitizing medications or creams;
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences
São Paulo, São Paulo, 01502001
Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences
São Paulo
About this study
Official title: Photobiomodulation in the Treatment of Spasticity in Children With Cerebral Palsy. A Controlled, Randomized, Blind Study
Cerebral palsy is a non-progressive, permanent syndrome that occurs in childhood and is accompanied by motor, tônus and posture disorders. Its etiology is related to an insult or damage to the central nervous system in maturation. Approximately 80% of cerebral palsy course with spasticity, which, when left untreated, will generate pain and functional, anatomical and structural changes, with a negative impact. Photobiomodulation therapy has biological effects of tissue regeneration, muscle relaxation, vasodilation, reduction of the inflammatory process and relief of pain symptoms already described in the literature, in addition to being feasible, practical, safe, without side effects, painless and non-invasive.This study is a blind, randomized and controlled clinical trial that will evaluate the effect of photobiomodulation in reducing gastrocnemius muscle spasticity in children aged 2 to 18 years, diagnosed with spastic cerebral palsy of lower limbs of any etiology for at least 03 months and randomized into two groups: application of Low Intensity LED Therapy in the medial and right lateral gastrocnemius muscles (device power of 100mW, wavelength of 850nm, energy of 3J/cm2/point, once a week, making 08 therapeutic days during 02 months) or placebo group Low-Intensity LED Therapy (same device turned off). Both groups will also receive the standard treatment for spasticity. To assess the response to therapy, the outcomes evaluated will be the modified Ashworth Scale, the Mobility Domain of Pediatric evaluation of disability inventory, the Gross Motor Function Classification System scale and passive and active range of motion of the ankle analyzed at the pré and post each therapeutic session and in the pre and post therapeutic period of 08 sessions.
Read the detailed description
Cerebral palsy is a non-progressive, permanent syndrome that occurs in childhood and is accompanied by motor, tonus and posture disorders. Its etiology is related to an insult or damage to the central nervous system in maturation, during the prenatal, perinatal or postnatal period, when the central nervous system has not yet fully developed.
Approximately 80% of cerebral palsy course with spasticity, which, when left untreated, will generate pain and functional, anatomical and structural changes in bones, joints, muscles, tendons and nerve junctions, with a negative impact on quality of life, social participation and functionality of this individual. In parallel, photobiomodulation therapy has biological effects of tissue regeneration, muscle relaxation, vasodilation, reduction of the inflammatory process and relief of pain symptoms already described in the literature, in addition to being feasible, practical, safe, without side effects, painless and non-invasive.Objectives and methods: this study is a pilot, double-blind, randomized and controlled clinical trial that will evaluate the effect of photobiomodulation in reducing gastrocnemius muscle spasticity in 28 children aged 2 to 18 years, diagnosed with spastic cerebral palsy of right lower limb of any etiology for at least 03 months, selected at the
Physiotherapy Service of Universidade Nove de Julho and randomized into two groups:
application of Low Intensity LED Therapy in the medial and right lateral gastrocnemius muscles (device power of 100mW, wavelength of 850nm, energy of 1.5 J/point, applied in 02 points per muscle, for 15 seconds, frequency of once a week, making 8 therapeutic days) or placebo group Low-Intensity LED Therapy (same device turned off). Patients with fixed anatomical deformity of the ankle with less than 90 degrees of dorsiflexion amplitude, malnutrition, severe gastroesophageal reflux disease and another type of associated movement disorder will be excluded. Both groups will also receive the standard treatment for spasticity performed by the hospital's rehabilitation health team.
To assess the response to therapy, the outcomes evaluated will be the modified Ashworth Scale (MAS), the Mobility Domain of Pediatric Evaluation of Disability Inventory for children (PEDI), the Gross Motor Function Classification System scale (GMFCS) and passive range of motion (ROM) of the ankle analyzed at the end of each therapeutic session and in the pre therapeutic period of 08 weeeks. Epidemiological data will be collected from the medical records of participants in the physiotherapy for characterizing the sample (age, gender,etiology of brain injury and type of paralysis, injury time, medications, comorbidities, previous surgeries, length of physiotherapy treatment at the start of the study, description of the physiotherapy treatment in use, use of a walking aid or orthosis. Data will be statistically analyzed and positive or negative results reported and discussed.
- Being tested
- Photobiomodulation, Institution's Standard Physiotherapy, Photobiomodulation Placebo
- Medical subject headings
- Muscle Spasticity, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationRadiation
Also called Low Level Laser Therapy
LED photobiomodulation therapy, once a week, for 08 consecutive weeks in the same day of the institution's standard physiotherapy session that the patient already uses regularly (not linked to the study). PBM will be transcutaneously, punctual application of the LED in the medial and lateral gastrocnemius muscles of the right lower limb, in contact mode, 3J/cm2, with a 850nm wavelenght.
Institution's Standard PhysiotherapyOther
Also called Rehabilitation Physiotherapy
Physiotherapy treatment on the University, occur 2 therapeutic days per week, for 08 consecutive weeks (one of them in the same day of the PBM session). It consists of the use of motor physiotherapy, posture guidelines, stretching, positioning, joint range gain, ergonomics, sensory stimulation and proprioception, motor strengthening, tonus adjustment, functional training of upper and lower limbs, guidelines for the use of orthoses, stands, parapodium, parallel bars or wheelchair when needed. These are 45-minute sessions conducted by a physiotherapist.
Photobiomodulation PlaceboRadiation
The same procedures of PBM group but device will be turned off
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation (PBM) Treatment Group | Experimental | Photobiomodulation therapy sessions will be carried out in the physiotherapy environment on the University, once a week, for 08 consecutive weeks in the same day of the institution's standard physiotherapy session that the patient already uses regularly (not linked to the study). will be transcutaneously, punctual application of the LED in the medial and lateral gastrocnemius muscles of the right lower limb, in contact mode, 3J/cm2, with a 850nm wavelenght (01 point per gastroc, muscle). All patients will received the PBM protocol + the standard physiotherapy rehabilitation treatment of the institute not linked to the study, and which the patient already uses regularly. Receives: Radiation: Photobiomodulation; Other: Institution's Standard Physiotherapy |
| Photobiomodulation (PBM) Placebo Group | Placebo comparator | PBM placebo therapy sessions will be carried out with the same characteristics of PBM treatment Group but with device turned off. All patients will received also the standard physiotherapy rehabilitation treatment of the institute not linked to the study, and which the patient already uses regularly. Receives: Other: Institution's Standard Physiotherapy; Radiation: Photobiomodulation Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 8 weeks (after PBM treatment) Spasticity Grade
Clinical evaluation of spasticity grade by Modified Asworth Scale (its performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension ( the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion scoring
0 No increase in tone
1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension.
1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout ROM
2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed
3 considerable increase in tone, passive movement difficult
4 limb rigid in flexion or extension
Measured: At the basal assessment (baseline immediately before the PBM therapy), immediately after carrying out each session of PBM therapy, and 14 days after last session of PBM therapy
Secondary outcomes (3)
Change from baseline to 8 weeks (after PBM treatment) Gross motor Classification System
Clinical evaluation with the aim of understanding the patient's situation in relation to their functional abilities and limitations
Measured: At the basal assessment (baseline immediately before the PBM therapy), and 14 days after last session of PBM therapy
Change from baseline to 8 weeks (after PBM treatment) Passive range of motion of the ankle
Its measurement is carried out with the help of a goniometer. The measurement of passive ROM is done with a professional performing the movement through the evaluated
Measured: At the basal assessment (baseline immediately before the PBM therapy), immediately after carrying out each session of PBM therapy, and 14 days after last session of PBM therapy
Change from baseline to 8 weeks (after PBM treatment) on mobility domain of Pediatric Evaluation of Disability Inventory
assesses key functional capabilities and performance in children ages 6 months to 7 years.
Measured: At the basal assessment (baseline immediately before the PBM therapy), and 14 days after last session of PBM therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Aug 2023
- Primary completion1 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
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
- Investigators
- Rebeca B Cecatto, Study director, University of Nove de JulhoAriane Zoll, Principal investigator, Universiade Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536751
- Sponsor's protocol ID
- CerebralPalsyPhotobio
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be share with Mendeley Data database or similar
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation in the Treatment of Spasticity in Children With Cerebral Palsy. A Controlled, Randomized, Blind Study
- ClinicalTrials.gov ID
- NCT06536751
- Acronym / sponsor ID
- CerebralPalsyPhotobio
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Aug 2024 (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.
Cerebral palsy is a non-progressive, permanent syndrome that occurs in childhood and is accompanied by motor, tônus and posture disorders. Its etiology is related to an insult or damage to the central nervous system in maturation. Approximately 80% of cerebral palsy course with spasticity, which, when left untreated, will generate pain and functional, anatomical and structural changes, with a negative impact. Photobiomodulation therapy has biological effects of tissue regeneration, muscle relaxation, vasodilation, reduction of the inflammatory process and relief of pain symptoms already described in the literature, in addition to being feasible, practical, safe, without side effects, painless and non-invasive.This study is a blind, randomized and controlled clinical trial that will evaluate the effect of photobiomodulation in reducing gastrocnemius muscle spasticity in children aged 2 to 18 years, diagnosed with spastic cerebral palsy of lower limbs of any etiology for at least 03 months and randomized into two groups: application of Low Intensity LED Therapy in the medial and right lateral gastrocnemius muscles (device power of 100mW, wavelength of 850nm, energy of 3J/cm2/point, once a week, making 08 therapeutic days during 02 months) or placebo group Low-Intensity LED Therapy (same device turned off). Both groups will also receive the standard treatment for spasticity. To assess the response to therapy, the outcomes evaluated will be the modified Ashworth Scale, the Mobility Domain of Pediatric evaluation of disability inventory, the Gross Motor Function Classification System scale and passive and active range of motion of the ankle analyzed at the pré and post each therapeutic session and in the pre and post therapeutic period of 08 sessions.
Detailed description
Cerebral palsy is a non-progressive, permanent syndrome that occurs in childhood and is accompanied by motor, tonus and posture disorders. Its etiology is related to an insult or damage to the central nervous system in maturation, during the prenatal, perinatal or postnatal period, when the central nervous system has not yet fully developed.
Approximately 80% of cerebral palsy course with spasticity, which, when left untreated, will generate pain and functional, anatomical and structural changes in bones, joints, muscles, tendons and nerve junctions, with a negative impact on quality of life, social participation and functionality of this individual. In parallel, photobiomodulation therapy has biological effects of tissue regeneration, muscle relaxation, vasodilation, reduction of the inflammatory process and relief of pain symptoms already described in the literature, in addition to being feasible, practical, safe, without side effects, painless and non-invasive.Objectives and methods: this study is a pilot, double-blind, randomized and controlled clinical trial that will evaluate the effect of photobiomodulation in reducing gastrocnemius muscle spasticity in 28 children aged 2 to 18 years, diagnosed with spastic cerebral palsy of right lower limb of any etiology for at least 03 months, selected at the
Physiotherapy Service of Universidade Nove de Julho and randomized into two groups:
application of Low Intensity LED Therapy in the medial and right lateral gastrocnemius muscles (device power of 100mW, wavelength of 850nm, energy of 1.5 J/point, applied in 02 points per muscle, for 15 seconds, frequency of once a week, making 8 therapeutic days) or placebo group Low-Intensity LED Therapy (same device turned off). Patients with fixed anatomical deformity of the ankle with less than 90 degrees of dorsiflexion amplitude, malnutrition, severe gastroesophageal reflux disease and another type of associated movement disorder will be excluded. Both groups will also receive the standard treatment for spasticity performed by the hospital's rehabilitation health team.
To assess the response to therapy, the outcomes evaluated will be the modified Ashworth Scale (MAS), the Mobility Domain of Pediatric Evaluation of Disability Inventory for children (PEDI), the Gross Motor Function Classification System scale (GMFCS) and passive range of motion (ROM) of the ankle analyzed at the end of each therapeutic session and in the pre therapeutic period of 08 weeeks. Epidemiological data will be collected from the medical records of participants in the physiotherapy for characterizing the sample (age, gender,etiology of brain injury and type of paralysis, injury time, medications, comorbidities, previous surgeries, length of physiotherapy treatment at the start of the study, description of the physiotherapy treatment in use, use of a walking aid or orthosis. Data will be statistically analyzed and positive or negative results reported and discussed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation (PBM) Treatment Group | Experimental | Radiation: Photobiomodulation, Other: Institution's Standard PhysiotherapyPhotobiomodulation therapy sessions will be carried out in the physiotherapy environment on the University, once a week, for 08 consecutive weeks in the same day of the institution's standard physiotherapy session that the patient already uses regularly (not linked to the study). will be transcutaneously, punctual application of the LED in the medial and lateral gastrocnemius muscles of the right lower limb, in contact mode, 3J/cm2, with a 850nm wavelenght (01 point per gastroc, muscle). All patients will received the PBM protocol + the standard physiotherapy rehabilitation treatment of the institute not linked to the study, and which the patient already uses regularly. |
| Photobiomodulation (PBM) Placebo Group | Placebo comparator | Other: Institution's Standard Physiotherapy, Radiation: Photobiomodulation PlaceboPBM placebo therapy sessions will be carried out with the same characteristics of PBM treatment Group but with device turned off. All patients will received also the standard physiotherapy rehabilitation treatment of the institute not linked to the study, and which the patient already uses regularly. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with diagnosis of spastic cerebral palsy affecting inferior limbs from any etiology;
- Cerebral palsy duration at least 03 months;
- Patients ongoing physiotherapy treatment at University.
Key exclusion criteria (9 listed)
- Patients with fixed anatomical deformities of the ankle that do not allow ankle joint movement of at least 90 degrees of amplitude;
- Patients with malnutrition;
- Patients who present acute clinical conditions with potential for increase spasticity such as acute fractures, skin ulcers, acute infections;
- Patients with severe gastroesophageal reflux disease;
- Patients with another type of movement or tone disorder;
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 |
|---|---|---|
| PhotobiomodulationAlso: Low Level Laser TherapyLED photobiomodulation therapy, once a week, for 08 consecutive weeks in the same day of the institution's standard physiotherapy session that the patient already uses regularly (not linked to the study). PBM will be transcutaneously, punctual application of the LED in the medial and lateral gastrocnemius muscles of the right lower limb, in contact mode, 3J/cm2, with a 850nm wavelenght. | Radiation | Photobiomodulation (PBM) Treatment Group |
| Institution's Standard PhysiotherapyAlso: Rehabilitation PhysiotherapyPhysiotherapy treatment on the University, occur 2 therapeutic days per week, for 08 consecutive weeks (one of them in the same day of the PBM session). It consists of the use of motor physiotherapy, posture guidelines, stretching, positioning, joint range gain, ergonomics, sensory stimulation and proprioception, motor strengthening, tonus adjustment, functional training of upper and lower limbs, guidelines for the use of orthoses, stands, parapodium, parallel bars or wheelchair when needed. These are 45-minute sessions conducted by a physiotherapist. | Other | Photobiomodulation (PBM) Placebo Group, Photobiomodulation (PBM) Treatment Group |
| Photobiomodulation PlaceboThe same procedures of PBM group but device will be turned off | Radiation | Photobiomodulation (PBM) Placebo Group |
Primary outcome
Change from baseline to 8 weeks (after PBM treatment) Spasticity Grade
Time frame: At the basal assessment (baseline immediately before the PBM therapy), immediately after carrying out each session of PBM therapy, and 14 days after last session of PBM therapy
Clinical evaluation of spasticity grade by Modified Asworth Scale (its performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension ( the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion scoring 0 No increase in tone 1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension. 1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout ROM 2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed 3 considerable increase in tone, passive movement difficult 4 limb rigid in flexion or extension
3 secondary outcomes
Change from baseline to 8 weeks (after PBM treatment) Gross motor Classification System
Time frame: At the basal assessment (baseline immediately before the PBM therapy), and 14 days after last session of PBM therapy
Change from baseline to 8 weeks (after PBM treatment) Passive range of motion of the ankle
Time frame: At the basal assessment (baseline immediately before the PBM therapy), immediately after carrying out each session of PBM therapy, and 14 days after last session of PBM therapy
Change from baseline to 8 weeks (after PBM treatment) on mobility domain of Pediatric Evaluation of Disability Inventory
Time frame: At the basal assessment (baseline immediately before the PBM therapy), and 14 days after last session of PBM therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. The data will be share with Mendeley Data database or similar
Related trials for Muscle Spasticity
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
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. This study is not recruiting at the moment.
Rebeca B Cecatto study director
University of Nove de Julho
Ariane Zoll principal investigator
Universiade Nove de Julho
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Photobiomodulation and Institution's Standard Physiotherapy in people with Muscle Spasticity and Cerebral Palsy, run by University of Nove de Julho at 2 sites 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 8 weeks (after PBM treatment) Spasticity Grade (time frame: At the basal assessment (baseline immediately before the PBM therapy), immediately after carrying out each session of PBM therapy, and 14 days after last session of PBM therapy). 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 May 2026.