Therapeutic Photobiomodulation and Tretament of Spasticity

NCT06536751 | Completed Phase 2 DMC

• 1 other identifier: CerebralPalsyPhotobio
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Muscle Spasticity; Cerebral Palsy; Photobiomodulation; Low-Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  At the basal assessment (baseline immediately before the PBM therapy), and 14 days after last session of PBM therapy

Other Outcomes (1)

• Primary pilot statistical analysis

  May 2025

Study Arms (2)

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.

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.

Other: Institution's Standard Physiotherapy; Radiation: Photobiomodulation Placebo

Interventions

Photobiomodulation RADIATION

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.

Also known as: Low Level Laser Therapy

Photobiomodulation (PBM) Treatment Group

Institution's Standard Physiotherapy OTHER

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.

Also known as: Rehabilitation Physiotherapy

Photobiomodulation (PBM) Placebo Group; Photobiomodulation (PBM) Treatment Group

Photobiomodulation Placebo RADIATION

The same procedures of PBM group but device will be turned off

Photobiomodulation (PBM) Placebo Group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (2)

Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences

São Paulo, São Paulo, 01502001, Brazil

Location

Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences

São Paulo, Brazil

Location

MeSH Terms

Conditions

Muscle Spasticity; Cerebral Palsy

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Rebeca B Cecatto

  University of Nove de Julho

  STUDY DIRECTOR

• Ariane Zoll

  Universiade Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor M.D. Ph.D. Rebeca Boltes Cecatto

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 5, 2024
• Study Start: August 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (2)