Clinical trial NCT04035863: Effects of Photobiomodulation on Superficial Sensitivity and Muscle Activity of Individuals With Myelomeningocele
Official title: EVALUATION OF THE SENSORY-MOTOR RESPONSE IN PATIENTS WITH MYELOMENINGOCELE FOLLOWING TREATMENT WITH PHOTOBIOMODULATION
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myelomeningocele Without Hydrocephalus
Sensory Defect
Motor Activity
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Myelomeningocele is a neural tube defect that occurs between the third and fourth week of gestation. Functional impairment occurs due to dysplasia of the nerve roots, which can lead to flaccid paralysis and sensory-motor dysfunction below the level of the lesion. Although advances in the multidisciplinary treatment of myelomeningocele have led to functional improvements in affected children, novel therapeutic modalities, such as photobiomodulation (PBM), could be a promising complement to treatment. Objective: Evaluate the effectiveness of PBM combined with physiotherapeutic exercises on the sensory-motor response in individuals with myelomeningocele at the lower lumbar and sacral level. Participants will be recruited from the Integrated Health Clinic of University Nove de Julho and randomized into two groups: Grupo 1 - treatment with PBM at a wavelength of 808 nm + physical therapy; Grupo 2 - sham PBM + physical therapy. Evaluations will involve electromyography of the gastrocnemius, tibialis anterior and rectus femoris muscles of both lower limbs. Balance will be evaluated using the Pediatric Balance Scale. The sensory evaluation will be performed using the Semmes-Weinstein monofilament kit (Smiles®). BDNF levels will be determined using ELISA. The data will be analyzed with the aid of GraphPad PRISM version 7.0. The Kolmogorov-Smirnov test will be used to determine the normality of the data. Variables that fit the Gaussian curve will be expressed as mean and standard deviation values. The t-test will be used for the comparisons between groups, with the level of significance set to 95% (p \< 0.05).


Eligibility criteria: Inclusion Criteria:

* Age 5 to 16 years;
* diagnosis of myelomeningocele on the lower lumbar and sacral level;
* community ambulator;
* score above the cutoff point for age on the Mini Mental State Examination.

Exclusion Criteria:

* Cognitive impairment that compromises the ability to communicate and answer the questions that will be posed;
* allergy to latex; - manifestations secondary to MMC, such as hydrocephalus;
* congenital club foot; neuromuscular scoliosis;
* subluxation or luxation of hip and knee;
* other disease of the central nervous system, neoplasms, heart failure, renal, respiratory, hepatic.

Primary outcomes:
measure: Assessment of muscle activity
timeFrame: 10 minutes
measure: Sensory evaluation - monofilaments
timeFrame: 10 minutes
Secondary outcomes:
measure: Evaluation of balance
timeFrame: 10 minutos
measure: Analysis expression of brain-derived neurotrophic factor (BDNF)
timeFrame: 10 minutes
measure: Analysis expression Interleukin-10 (IL-10)
timeFrame: 10 minutes
Other outcomes:
Locations:
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