Using light therapy to reduce muscle spasticity in children with cerebral palsy

Photobiomodulation in the Treatment of Spasticity in Children With Cerebral Palsy. A Controlled, Randomized, Blind Study

This study is testing if light therapy can help reduce muscle tightness and improve movement in children with cerebral palsy.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 2 Years to 18 Years
• Sex: All
• Sponsor: University of Nove de Julho (Academic / other)
• Locations: 2 sites (São Paulo, SP and 1 other locations)
• Trial ID: NCT06536751 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of photobiomodulation therapy in reducing gastrocnemius muscle spasticity in children aged 2 to 18 years diagnosed with spastic cerebral palsy. The study is a double-blind, randomized, and controlled trial involving 28 participants who will receive either active light therapy or a placebo. The therapy aims to alleviate pain and improve muscle function through non-invasive treatment methods. Participants will be selected from the Physiotherapy Service of Universidade Nove de Julho and must have been undergoing physiotherapy for at least three months.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to 18 years with a diagnosis of spastic cerebral palsy affecting the lower limbs for at least three months.

Not a fit: Patients with fixed anatomical deformities of the ankle or other severe medical conditions may not benefit from this therapy.

Why it matters

Potential benefit: If successful, this therapy could significantly improve the quality of life and functional abilities of children with spastic cerebral palsy.

How similar studies have performed: Other studies have shown promising results with photobiomodulation therapy, indicating potential for success in this approach.

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;

Where this trial is running

São Paulo, SP and 1 other locations

• Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences — São Paulo, Sp, Brazil (Recruiting)
• Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences — Sao Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Ariane Zoll — Universiade Nove de Julho
• Study coordinator: Rebeca B Cecatto

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