Therapeutic Photobiomodulation and Tretament of Spasticity
Photobiomodulation in the Treatment of Spasticity in Children With Cerebral Palsy. A Controlled, Randomized, Blind Study
University of Nove de Julho
28 participants
Aug 15, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria9
- 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;
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Interventions
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.
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.
The same procedures of PBM group but device will be turned off
Locations(2)
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NCT06536751