Therapeutic Photobiomodulation and Tretament of Spasticity

April 27, 2026 updated by: Rebeca Boltes Cecatto, University of Nove de Julho

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01502001
        • Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Photobiomodulation (PBM) Treatment Group
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.
Radiation: Photobiomodulation
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.
Other Names:
  • Low Level Laser Therapy
Other: Institution's Standard 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.
Other Names:
  • Rehabilitation Physiotherapy
Placebo Comparator: Photobiomodulation (PBM) Placebo Group
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.
Other: Institution's Standard 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.
Other Names:
  • Rehabilitation Physiotherapy
Radiation: Photobiomodulation Placebo
The same procedures of PBM group but device will be turned off

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Clinical evaluation with the aim of understanding the patient's situation in relation to their functional abilities and limitations
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
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
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
assesses key functional capabilities and performance in children ages 6 months to 7 years.
At the basal assessment (baseline immediately before the PBM therapy), and 14 days after last session of PBM therapy

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Primary pilot statistical analysis
Time Frame: May 2025
In an initial pilot evaluation checking safety trends, initial efficacy, or need for sample size adjustments, data from the first 12 participants that complete the intervention protocol, will be statistically analyzed (7 from PBM group and 5 from placebo group).
May 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rebeca B Cecatto, University of Nove de Julho
  • Principal Investigator: Ariane Zoll, Universiade Nove de Julho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CerebralPalsyPhotobio

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be share with Mendeley Data database or similar

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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