Effects of Photobiomodulation on Superficial Sensitivity and Muscle Activity of Individuals With Myelomeningocele

University of Nove de Julho

Status: Unknown

Conditions: Motor Activity; Sensory Defect; Myelomeningocele Without Hydrocephalus

Treatments: Device: Low level laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04035863

MieloTamiris

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

PBM + physiotherapy exercises

Experimental group

Description:

will be submitted to active PBM and physiotherapeutic exercises. For irradiation, the individuals will be positioned comfortably in lateral decubitus on the examining table. Three points will be irradiated at the lesion level with a wavelength of 808 nm, 25 J per point for 12 sessions. The same laser device (Laser DMC Therapy EC). Physical therapy will occur twice per week after PBM for six weeks. Static balance exercises will be performed with the feet together and tandem on a variety of different surfaces (hard surface, foam rubber and carpets with different textures) and sensory inputs (eyes open and closed). Dynamic balance exercises will involve walking forward and backward on firm and foam surfaces and circumventing obstacles. Muscle strengthening exercises, squatting and changing postural positions will also be performed. All activities will be in the form of play to maintain the children's interest

Treatment:

Device: Low level laser therapy

SHAM PBM + physiotherapy exercises

Sham Comparator group

Description:

will be submitted to sham PBM and physiotherapeutic exercises. For irradiation sham, the individuals will be positioned comfortably in lateral decubitus on the examining table. The same laser device (Laser DMC Therapy EC) will be used but the device will emit sound but not light. Physical therapy will occur twice per week after PBM for six weeks. Static balance exercises will be performed with the feet together and tandem on a variety of different surfaces (hard surface, foam rubber and carpets with different textures) and sensory inputs (eyes open and closed). Dynamic balance exercises will involve walking forward and backward on firm and foam surfaces and circumventing obstacles. Muscle strengthening exercises, squatting and changing postural positions will also be performed. All activities will be in the form of play to maintain the children's interest

Treatment:

Device: Low level laser therapy