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

Motor Activity Clinical Trial

Official title:

EVALUATION OF THE SENSORY-MOTOR RESPONSE IN PATIENTS WITH MYELOMENINGOCELE FOLLOWING TREATMENT WITH PHOTOBIOMODULATION

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04035863
• Other study ID #: MieloTamiris
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: May 3, 2020

Study information

• Verified date: July 2019
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 3, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hydrocephalus
• Meningomyelocele
• Motor Activity
• Myelomeningocele Without Hydrocephalus
• Sensory Defect

Intervention

Device:
• Low level laser therapy
For the PBM protocol, articles of interest were identified through analyses of titles and abstracts. Articles addressing PBM in experimental models or clinical trials of spinal cord injuries were included and articles not pertinent to the proposed study were excluded. Next, the selected articles were analyzed and used for the creation of an initial protocol (Table 1). For irradiation, the individuals will be positioned comfortably in lateral decubitus on the examining table. Three points will be irradiated above the lesion level, which will be located using an imaging exam brought by the guardian on the day of the evaluation. After determining the lesion level, palpation of the transverse processes of the vertebrae will be performed. The same laser device (Laser DMC Therapy EC) will be used for both groups. For the placebo group, the device will emit sound but not light.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of muscle activity	Electromyography (EMG) will be performed with the EMG System®. The participants will be placed on an examining table and the skin will be cleaned with tissues soaked in alcohol for the placement of the markers. Disposable self-adhesive Ag/AgCl surface electrodes (Noraxon) measuring 10 mm in diameter will be attached to the belly of the lateral gastrocnemius, tibialis anterior and rectus femoris muscles on both lower limbs to capture the EMG signals. A reference electrode will be placed on the left wrist of the volunteers to impede interference of external noise	10 minutes
Primary	Sensory evaluation - monofilaments	The sensory evaluation will be performed using the Semmes-Weinstein kit (Smiles®), which is a set of six nylon monofilaments of the same length that exert force on the specific area tested. Each monofilament has a different color and diameter: green (0.05 g), blue (0.2 g), violet (2 g), red (4 g), orang (10 g) and magenta (300 g). The score ranges from seven (green monofilament) to 1 (magenta monofilament). The test will be performed on the following dermatomes: L1, L2, L4, L5, S1, S2 and S3.	10 minutes
Secondary	Evaluation of balance	Balance will be evaluated using the Pediatric Balance Scale, which consists of 14 items scored from 0 to 4 points. The maximum score is 56, with higher scores denoting better balance.	10 minutos
Secondary	Analysis expression of brain-derived neurotrophic factor (BDNF)	BDNF be quantified in saliva samples from the participants using ELISA MAX HUMAN kits (BioLegend), which contain capture and detection antibodies for the precise quantification of each cytokine. All kits will be used following the manufacturer's instructions. The optical density of the samples will be measured in a spectrophotometer at 450 nm.; Collection of saliva	10 minutes
Secondary	Analysis expression Interleukin-10 (IL-10)	IL-10 will be quantified in saliva samples from the participants using ELISA MAX HUMAN kits (BioLegend), which contain capture and detection antibodies for the precise quantification of each cytokine. All kits will be used following the manufacturer's instructions. The optical density of the samples will be measured in a spectrophotometer at 450 nm.	10 minutes