Therapeutic Photobiomodulation and Tretament of Spasticity
NCT Number: NCT06536751
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Muscle Spasticity|Cerebral Palsy|Photobiomodulation|Low-Level Laser Therapy
Interventions: RADIATION: Photobiomodulation|OTHER: Institution's Standard Physiotherapy|RADIATION: Photobiomodulation Placebo
Sponsor: University of Nove de Julho
Sex: ALL
Age: CHILD, ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-07-31
Locations: Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences, Sao Paulo, Brazil

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.

Primary Outcome Measures: 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 Outcome Measures: Change from baseline to 8 weeks (after PBM treatment) Gross motor Classification System, 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, 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, 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