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

Primary Purpose

Myelomeningocele Without Hydrocephalus, Sensory Defect, Motor Activity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low level laser therapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelomeningocele Without Hydrocephalus

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    PBM + physiotherapy exercises

    SHAM PBM + physiotherapy exercises

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    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
    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.

    Secondary Outcome Measures

    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.
    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
    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.

    Full Information

    First Posted
    July 24, 2019
    Last Updated
    July 26, 2019
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04035863
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2, 2019 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    May 3, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myelomeningocele Without Hydrocephalus, Sensory Defect, Motor Activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PBM + physiotherapy exercises
    Arm Type
    Experimental
    Arm 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
    Arm Title
    SHAM PBM + physiotherapy exercises
    Arm Type
    Sham Comparator
    Arm 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
    Intervention Type
    Device
    Intervention Name(s)
    Low level laser therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Assessment of muscle activity
    Description
    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
    Time Frame
    10 minutes
    Title
    Sensory evaluation - monofilaments
    Description
    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.
    Time Frame
    10 minutes
    Secondary Outcome Measure Information:
    Title
    Evaluation of balance
    Description
    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.
    Time Frame
    10 minutos
    Title
    Analysis expression of brain-derived neurotrophic factor (BDNF)
    Description
    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
    Time Frame
    10 minutes
    Title
    Analysis expression Interleukin-10 (IL-10)
    Description
    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.
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

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

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