<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04425330</url>
  </required_header>
  <id_info>
    <org_study_id>Mielomeningocele</org_study_id>
    <nct_id>NCT04425330</nct_id>
  </id_info>
  <brief_title>Effects of Physical Therapy Associated With Photobiomodulation on Myelomeningocele</brief_title>
  <official_title>The Effects of Physical Therapy Associated With Photobiomodulation on Functional Performance in Children With Low Lumbar and Sacral Myelomeningocele - A Randomized, Blinded Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nove de Julho</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Myelomeningocele is a severe type of spina bifida, resulting from improper closure of the&#xD;
      neural tube. This condition drastically affects the structures of the spinal cord, as a&#xD;
      result the spinal cord, nerve roots and meninges are exposed during pregnancy resulting in&#xD;
      deficiencies. The combination of these deficiencies results in an overall decrease in&#xD;
      mobility and functional participation. There is little evidence about physical therapy&#xD;
      interventions in this population. However, it is known that the International Classification&#xD;
      of Functionality, Disability and Health for Children and Youth is a useful tool to assist&#xD;
      therapists in analyzing problems and thinking about the focus of the intervention. The&#xD;
      current literature demonstrates that resources such as low intensity light, also known as&#xD;
      photobiomodulation as a therapeutic means, can be auxiliary means in the rehabilitation of&#xD;
      neurological conditions, as studies show that photobiomoduction promotes sensory and motor&#xD;
      recovery in the animal model of spinal cord injury . And a clinical trial showed that after&#xD;
      photobiomodulation treatment combined with photobiomodulation, individuals with spinal cord&#xD;
      injuries improved motor and sensory function. Therefore, the objective of the study is to&#xD;
      evaluate the effects of physical therapy associated with photobiomodulation on functional&#xD;
      performance in children with low and sacral lumbar myelomeningocele. Materials and methods:&#xD;
      Participants will be recruited at the Integrated Health Clinic of University Nove de Julho.&#xD;
      Those who meet the inclusion criteria will be randomized to two groups using a randomization&#xD;
      site (randomization.com). Group 1 will be submitted to active PBM and physiotherapeutic&#xD;
      exercises. Group 2 will be submitted to sham PBM and physiotherapeutic exercises. Irradiation&#xD;
      will be carried out with LED at a wavelength of 850 nm, energy of 25 J per point, 50 seconds&#xD;
      per point and a power of 200 mW. The same device will be used in the placebo group but will&#xD;
      not emit light. Muscle activity will be assessed using a portable electromyograph (BTS&#xD;
      Engineering) and the sit-to-stand task will be performed as a measure of functioning.&#xD;
      Electrodes will be positioned on the lateral gastrocnemius, tibialis anterior and rectus&#xD;
      femoris muscles. The Pediatric Evaluation of Disability Inventory will be used to assess the&#xD;
      functional independence of the children. Quality of life will be assessed using the Child&#xD;
      Health Questionnaire - Parent Form 50. Change in participation will be assessed using the&#xD;
      Participation and Environment Measure for Children and Youth (PEM-CY). The sensory evaluation&#xD;
      will be performed using the Semmes-Weinstein kit (AesthesioVR kit, California, EUA, DanMic&#xD;
      Global). The protein expression of BDNF will be quantified from saliva samples using the&#xD;
      ELISA technique. The data will be analyzed with the aid of GraphPad PRISM. The results of&#xD;
      this study can contribute to a better understanding of the effectiveness of physiotherapy on&#xD;
      the functionality and quality of life of children with myelomeningocele. In addition, FBM is&#xD;
      a non-invasive treatment, and a fast procedure and can be a promising approach in the&#xD;
      treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 3, 2020</start_date>
  <completion_date type="Anticipated">February 3, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants will not know whether which group they are participating in, that is, treatment group or placebo with photobiomodulation.&#xD;
The evaluator and who will perform the exercises will not know which group the participant is participating in relation to photobiomodulation.&#xD;
A therapist who will not participate in assessments and physiotherapy sessions will perform the application of photobiomodulation.&#xD;
The microtubes with the saliva samples will be marked with numbers corresponding to each participant, so the evaluator will not know which group the sample corresponds to. A therapist will be responsible for the assessment and electromyography scales.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Electromyography</measure>
    <time_frame>30 minutes</time_frame>
    <description>Muscle activity will be assessed using a portable electromyography (BTS Engineering) synchronized to the BST EMG analyzer system. As a measure of functionality, the sit-to-stand task will be performed.&#xD;
The electrodes will be positioned on the muscles: lateral gastrocnemius, anterior tibialis and rectus femoris.&#xD;
For the assessment of the sit-to-stand the participant will be positioned in a chair with 90º flexion of the hip, knee, ankle and supported feet.&#xD;
An assessment will be carried out with the child sitting at rest. Afterwards, the child will be asked to stand up and remain in an upright position for 10 seconds. Afterwards the child will be asked to sit down. The repetition of the sit-to-stand task will be performed 3 times with an interval of 5 minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensory evaluation - monofilaments</measure>
    <time_frame>10 minutes</time_frame>
    <description>The sensory evaluation will be performed using the Semmes-Weinstein kit (AesthesioVR kit, California, EUA, DanMic Global), 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: the kit contains 20 monofilaments, which exert different forces upon bending, with 20 target forces: 0.008 g;0.02 g, 0.04 g, 0.07 g, 0.16 g, 0.40 g, 0.60 g, 1.0 g, 1.4 g, 2.0 g, 4.0 g, 6.0 g, 8.0 g, 10 g, 15 g, 26 g, 60 g, 100 g, 180 g, and 300 g.). The test will be performed on the following dermatomes: L1, L2, L4, L5, S1, S2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of functional skills</measure>
    <time_frame>10 minutes</time_frame>
    <description>To assess the functional independence of children, the Pediatric Evaluation of Disability Inventory (PEDI) will be used. This child assessment tool assesses functional performance, in terms of capabilities (functional skills) and performance of what the child actually does in response to the environment (the amount of caregiver assistance needed to perform daily tasks) in three domains: self-care, mobility and social function. This inventory was translated into Portuguese and culturally adapted to take into account Brazilian socio-cultural specificities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>10 minutes</time_frame>
    <description>The quality of life will be assessed through the Child Health Questionnaire - Parent Report 50 (Child Health Questionnaire - Parent Form 50 - CHQ-PF50), which is a useful tool, since it allows to evaluate this aspect from the parents' perspective.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDNF evaluation</measure>
    <time_frame>5 minutes</time_frame>
    <description>Protein expression of BDNF will be quantified from saliva samples using the ELISA technique. DELUXE HUMAN commercial kit (BioLegend®) will be used. The analysis will be according to the manufacturer's instructions. The optical density of the samples will be measured on the spectrophotometer at 450 nm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participation and Environment Measure</measure>
    <time_frame>40 minutes</time_frame>
    <description>The PEM-CY is a parent-report instrument that examines participation and environment factors that affect the participation of children across three settings: home, school, and community.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Physical Therapy Modalities</condition>
  <arm_group>
    <arm_group_label>physiotherapy exercises + PBM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physiotherapy exercises will be individualized and personalized for each child. It will take into account complaints and / or motor delay resulting from the injury. Circuit exercises will be performed involving muscle strengthening exercises, sensory stimulation and balance.&#xD;
For irradiation, the subjects will be positioned comfortably in prone position on the examination table. Four points will be irradiated above the injury level. The level of the lesion will be located by palpation. Four points will be irradiated above the injury level. The level of the lesion will be located by palpation. The irradiation will be with LED with a wavelength of 850 nm, energy per point of 25 J, 50 seconds per point and power of 200 mW.&#xD;
Treatment will be performed in 24 sessions 2 times a week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>physiotherapy exercises + SHAM PBM</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Physiotherapy exercises will be individualized and personalized for each child. It will take into account complaints and / or motor delay resulting from the injury. Circuit exercises will be performed involving muscle strengthening exercises, sensory stimulation and balance.&#xD;
For irradiation, the subjects will be positioned comfortably in prone position on the examination table. Four points will be irradiated above the injury level. The level of the lesion will be located by palpation. The same LED device will be used in groups. However, in the placebo group (Sham), the device does not emit light.&#xD;
Treatment will be performed in 24 sessions 2 times a week</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physiotherapy exercises</intervention_name>
    <description>The evidence on the effectiveness of physical therapy in children with myelomeningocele is limited. The International Classification of Functionality, Disability and Health for Children and Youth is a useful tool to assist therapists in analyzing problems about the focus of the intervention. The evidence in physical therapy practice for individuals of all ages with neurological disorders, focuses on 5 Ps: prevention, prediction, participation, personalized and plasticity. Thus, neurological physiotherapists must perform the care with a focus on preventing the patient's disabilities, predicting the ideal response of an intervention, through measures of results of the movement system. In addition, it is of paramount importance that the goal of rehabilitation is that people with neurological disabilities are fully included and participate in life activities that are important to them and that their care is personalized. All of these measures facilitate the process of positive plasticity.</description>
    <arm_group_label>physiotherapy exercises + PBM</arm_group_label>
    <arm_group_label>physiotherapy exercises + SHAM PBM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PBM</intervention_name>
    <description>Photobiomodulation occurs from the application of low intensity light such as low intensity laser and light emitting diode (LED). The therapeutic effectiveness of phototherapy is based on the absorption of photons by photoreceptors or chromophores. Studies on the experimental model of spinal cord injury have shown that both wavelengths have the potential to be an effective and non-invasive means of therapy, promoting axonal appearance, increased concentration of glial cells and nerve connections, in addition to functional and sensitive. The findings of a clinical trial involving individuals diagnosed with spinal cord injury demonstrate that PBM exerted positive effects on motor function, especially during isotonic contraction of stimulated muscles assessed by electromyography, and there was a recovery in sensory perception and muscle strength.</description>
    <arm_group_label>physiotherapy exercises + PBM</arm_group_label>
    <other_name>Low level laser therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SHAM PBM</intervention_name>
    <description>SHAM PBM</description>
    <arm_group_label>physiotherapy exercises + SHAM PBM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of myelomeningocele on the lower lumbar and sacral level;&#xD;
&#xD;
          -  able to perform the movement of sitting and standing with support&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment that compromises the ability to communicate&#xD;
&#xD;
          -  Allergy to latex; neuromuscular scoliosis; subluxation or dislocation of the hip and&#xD;
             knee;&#xD;
&#xD;
          -  other disease of the central nervous system.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Sandra Kalil Bussadori</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Meningomyelocele</keyword>
  <keyword>Low-Level Light Therapy</keyword>
  <keyword>Photobiomodulation</keyword>
  <keyword>Neurological Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningomyelocele</mesh_term>
    <mesh_term>Spina Bifida Cystica</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04425330
org study id: Mielomeningocele
nct id: NCT04425330
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Myelomeningocele is a severe type of spina bifida, resulting from improper closure of the
      neural tube. This condition drastically affects the structures of the spinal cord, as a
      result the spinal cord, nerve roots and meninges are exposed during pregnancy resulting in
      deficiencies. The combination of these deficiencies results in an overall decrease in
      mobility and functional participation. There is little evidence about physical therapy
      interventions in this population. However, it is known that the International Classification
      of Functionality, Disability and Health for Children and Youth is a useful tool to assist
      therapists in analyzing problems and thinking about the focus of the intervention. The
      current literature demonstrates that resources such as low intensity light, also known as
      photobiomodulation as a therapeutic means, can be auxiliary means in the rehabilitation of
      neurological conditions, as studies show that photobiomoduction promotes sensory and motor
      recovery in the animal model of spinal cord injury . And a clinical trial showed that after
      photobiomodulation treatment combined with photobiomodulation, individuals with spinal cord
      injuries improved motor and sensory function. Therefore, the objective of the study is to
      evaluate the effects of physical therapy associated with photobiomodulation on functional
      performance in children with low and sacral lumbar myelomeningocele. Materials and methods:
      Participants will be recruited at the Integrated Health Clinic of University Nove de Julho.
      Those who meet the inclusion criteria will be randomized to two groups using a randomization
      site (randomization.com). Group 1 will be submitted to active PBM and physiotherapeutic
      exercises. Group 2 will be submitted to sham PBM and physiotherapeutic exercises. Irradiation
      will be carried out with LED at a wavelength of 850 nm, energy of 25 J per point, 50 seconds
      per point and a power of 200 mW. The same device will be used in the placebo group but will
      not emit light. Muscle activity will be assessed using a portable electromyograph (BTS
      Engineering) and the sit-to-stand task will be performed as a measure of functioning.
      Electrodes will be positioned on the lateral gastrocnemius, tibialis anterior and rectus
      femoris muscles. The Pediatric Evaluation of Disability Inventory will be used to assess the
      functional independence of the children. Quality of life will be assessed using the Child
      Health Questionnaire - Parent Form 50. Change in participation will be assessed using the
      Participation and Environment Measure for Children and Youth (PEM-CY). The sensory evaluation
      will be performed using the Semmes-Weinstein kit (AesthesioVR kit, California, EUA, DanMic
      Global). The protein expression of BDNF will be quantified from saliva samples using the
      ELISA technique. The data will be analyzed with the aid of GraphPad PRISM. The results of
      this study can contribute to a better understanding of the effectiveness of physiotherapy on
      the functionality and quality of life of children with myelomeningocele. In addition, FBM is
      a non-invasive treatment, and a fast procedure and can be a promising approach in the
      treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participants will not know whether which group they are participating in, that is, treatment group or placebo with photobiomodulation.
The evaluator and who will perform the exercises will not know which group the participant is participating in relation to photobiomodulation.
A therapist who will not participate in assessments and physiotherapy sessions will perform the application of photobiomodulation.
The microtubes with the saliva samples will be marked with numbers corresponding to each participant, so the evaluator will not know which group the sample corresponds to. A therapist will be responsible for the assessment and electromyography scales.
measure: Electromyography
time frame: 30 minutes
description: Muscle activity will be assessed using a portable electromyography (BTS Engineering) synchronized to the BST EMG analyzer system. As a measure of functionality, the sit-to-stand task will be performed.
The electrodes will be positioned on the muscles: lateral gastrocnemius, anterior tibialis and rectus femoris.
For the assessment of the sit-to-stand the participant will be positioned in a chair with 90º flexion of the hip, knee, ankle and supported feet.
An assessment will be carried out with the child sitting at rest. Afterwards, the child will be asked to stand up and remain in an upright position for 10 seconds. Afterwards the child will be asked to sit down. The repetition of the sit-to-stand task will be performed 3 times with an interval of 5 minutes.
measure: Sensory evaluation - monofilaments
time frame: 10 minutes
description: The sensory evaluation will be performed using the Semmes-Weinstein kit (AesthesioVR kit, California, EUA, DanMic Global), 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: the kit contains 20 monofilaments, which exert different forces upon bending, with 20 target forces: 0.008 g;0.02 g, 0.04 g, 0.07 g, 0.16 g, 0.40 g, 0.60 g, 1.0 g, 1.4 g, 2.0 g, 4.0 g, 6.0 g, 8.0 g, 10 g, 15 g, 26 g, 60 g, 100 g, 180 g, and 300 g.). The test will be performed on the following dermatomes: L1, L2, L4, L5, S1, S2.
measure: Assessment of functional skills
time frame: 10 minutes
description: To assess the functional independence of children, the Pediatric Evaluation of Disability Inventory (PEDI) will be used. This child assessment tool assesses functional performance, in terms of capabilities (functional skills) and performance of what the child actually does in response to the environment (the amount of caregiver assistance needed to perform daily tasks) in three domains: self-care, mobility and social function. This inventory was translated into Portuguese and culturally adapted to take into account Brazilian socio-cultural specificities.
measure: Quality of life assessment
time frame: 10 minutes
description: The quality of life will be assessed through the Child Health Questionnaire - Parent Report 50 (Child Health Questionnaire - Parent Form 50 - CHQ-PF50), which is a useful tool, since it allows to evaluate this aspect from the parents' perspective.
measure: BDNF evaluation
time frame: 5 minutes
description: Protein expression of BDNF will be quantified from saliva samples using the ELISA technique. DELUXE HUMAN commercial kit (BioLegend®) will be used. The analysis will be according to the manufacturer's instructions. The optical density of the samples will be measured on the spectrophotometer at 450 nm.
measure: Participation and Environment Measure
time frame: 40 minutes
description: The PEM-CY is a parent-report instrument that examines participation and environment factors that affect the participation of children across three settings: home, school, and community.
arm group label: physiotherapy exercises + PBM
arm group type: Experimental
description: Physiotherapy exercises will be individualized and personalized for each child. It will take into account complaints and / or motor delay resulting from the injury. Circuit exercises will be performed involving muscle strengthening exercises, sensory stimulation and balance.
For irradiation, the subjects will be positioned comfortably in prone position on the examination table. Four points will be irradiated above the injury level. The level of the lesion will be located by palpation. Four points will be irradiated above the injury level. The level of the lesion will be located by palpation. The irradiation will be with LED with a wavelength of 850 nm, energy per point of 25 J, 50 seconds per point and power of 200 mW.
Treatment will be performed in 24 sessions 2 times a week
arm group label: physiotherapy exercises + SHAM PBM
arm group type: Sham Comparator
description: Physiotherapy exercises will be individualized and personalized for each child. It will take into account complaints and / or motor delay resulting from the injury. Circuit exercises will be performed involving muscle strengthening exercises, sensory stimulation and balance.
For irradiation, the subjects will be positioned comfortably in prone position on the examination table. Four points will be irradiated above the injury level. The level of the lesion will be located by palpation. The same LED device will be used in groups. However, in the placebo group (Sham), the device does not emit light.
Treatment will be performed in 24 sessions 2 times a week
intervention type: Other
intervention name: physiotherapy exercises
description: The evidence on the effectiveness of physical therapy in children with myelomeningocele is limited. The International Classification of Functionality, Disability and Health for Children and Youth is a useful tool to assist therapists in analyzing problems about the focus of the intervention. The evidence in physical therapy practice for individuals of all ages with neurological disorders, focuses on 5 Ps: prevention, prediction, participation, personalized and plasticity. Thus, neurological physiotherapists must perform the care with a focus on preventing the patient's disabilities, predicting the ideal response of an intervention, through measures of results of the movement system. In addition, it is of paramount importance that the goal of rehabilitation is that people with neurological disabilities are fully included and participate in life activities that are important to them and that their care is personalized. All of these measures facilitate the process of positive plasticity.
arm group label: physiotherapy exercises + PBM
arm group label: physiotherapy exercises + SHAM PBM
intervention type: Other
intervention name: PBM
description: Photobiomodulation occurs from the application of low intensity light such as low intensity laser and light emitting diode (LED). The therapeutic effectiveness of phototherapy is based on the absorption of photons by photoreceptors or chromophores. Studies on the experimental model of spinal cord injury have shown that both wavelengths have the potential to be an effective and non-invasive means of therapy, promoting axonal appearance, increased concentration of glial cells and nerve connections, in addition to functional and sensitive. The findings of a clinical trial involving individuals diagnosed with spinal cord injury demonstrate that PBM exerted positive effects on motor function, especially during isotonic contraction of stimulated muscles assessed by electromyography, and there was a recovery in sensory perception and muscle strength.
arm group label: physiotherapy exercises + PBM
other name: Low level laser therapy
intervention type: Other
intervention name: SHAM PBM
description: SHAM PBM
arm group label: physiotherapy exercises + SHAM PBM
criteria: 
gender: All
minimum age: 5 Years
maximum age: 14 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Sandra Kalil Bussadori
investigator title: Professor
mesh term: Meningomyelocele
mesh term: Spina Bifida Cystica