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Search / Trial NCT06536751

Therapeutic Photobiomodulation and Tretament of Spasticity

Launched by UNIVERSITY OF NOVE DE JULHO · Jul 30, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how effective a treatment called photobiomodulation (a type of low-level laser therapy) is in reducing muscle tightness, known as spasticity, in children with spastic cerebral palsy. Spasticity can cause pain and difficulties with movement, so finding effective treatments is important. The study involves children aged 2 to 18 who have been diagnosed with spastic cerebral palsy affecting their legs for at least three months. Participants will be randomly assigned to either receive the light therapy or a placebo (a treatment that looks like the real therapy but has no active effect) while continuing their regular treatment for spasticity.

To be eligible, children must have spastic cerebral palsy affecting their lower limbs and be undergoing physiotherapy. However, those with certain conditions, like severe ankle deformities or infections, cannot participate. During the trial, participants can expect to receive therapy once a week for two months and will be assessed on their muscle tone and movement abilities before and after treatment. This study is a great opportunity for families seeking new ways to help manage spasticity in their children safely and effectively.

Gender

ALL

Eligibility criteria

  • 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;

About University Of Nove De Julho

The University of Nove de Julho (UNINOVE) is a prestigious educational institution located in São Paulo, Brazil, renowned for its commitment to advancing research and innovation in the field of health sciences. As a clinical trial sponsor, UNINOVE aims to foster collaboration between academia and the healthcare industry, facilitating the development and evaluation of novel therapeutic interventions. With a robust infrastructure and a team of experienced researchers, the university is dedicated to conducting high-quality clinical trials that adhere to rigorous ethical standards and regulatory guidelines, ultimately contributing to improved health outcomes and the enhancement of medical knowledge.

Locations

Sao Paulo, , Brazil

São Paulo, Sp, Brazil

Patients applied

0 patients applied

Trial Officials

Rebeca B Cecatto

Study Director

University of Nove de Julho

Ariane Zoll

Principal Investigator

Universiade Nove de Julho

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported