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Effects of Physical Therapy Associated With Photobiomodulation on Myelomeningocele

Primary Purpose

Physical Therapy Modalities

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physiotherapy exercises
PBM
SHAM PBM
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Therapy Modalities focused on measuring Meningomyelocele, Low-Level Light Therapy, Photobiomodulation, Neurological Rehabilitation

Eligibility Criteria

5 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of myelomeningocele on the lower lumbar and sacral level;
  • able to perform the movement of sitting and standing with support

Exclusion Criteria:

  • Cognitive impairment that compromises the ability to communicate
  • Allergy to latex; neuromuscular scoliosis; subluxation or dislocation of the hip and knee;
  • other disease of the central nervous system.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    physiotherapy exercises + PBM

    physiotherapy exercises + SHAM PBM

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    Electromyography
    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.

    Secondary Outcome Measures

    Sensory evaluation - monofilaments
    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.
    Assessment of functional skills
    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.
    Quality of life assessment
    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.
    BDNF evaluation
    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.
    Participation and Environment Measure
    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.

    Full Information

    First Posted
    June 6, 2020
    Last Updated
    October 6, 2020
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04425330
    Brief Title
    Effects of Physical Therapy Associated With Photobiomodulation on Myelomeningocele
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 3, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    February 3, 2022 (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 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Physical Therapy Modalities
    Keywords
    Meningomyelocele, Low-Level Light Therapy, Photobiomodulation, Neurological Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    physiotherapy exercises + PBM
    Arm Type
    Experimental
    Arm 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 Title
    physiotherapy exercises + SHAM PBM
    Arm Type
    Sham Comparator
    Arm 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(s)
    physiotherapy exercises
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    PBM
    Other Intervention Name(s)
    Low level laser therapy
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    SHAM PBM
    Intervention Description
    SHAM PBM
    Primary Outcome Measure Information:
    Title
    Electromyography
    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.
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    Sensory evaluation - monofilaments
    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.
    Time Frame
    10 minutes
    Title
    Assessment of functional skills
    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.
    Time Frame
    10 minutes
    Title
    Quality of life assessment
    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.
    Time Frame
    10 minutes
    Title
    BDNF evaluation
    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.
    Time Frame
    5 minutes
    Title
    Participation and Environment Measure
    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.
    Time Frame
    40 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of myelomeningocele on the lower lumbar and sacral level; able to perform the movement of sitting and standing with support Exclusion Criteria: Cognitive impairment that compromises the ability to communicate Allergy to latex; neuromuscular scoliosis; subluxation or dislocation of the hip and knee; other disease of the central nervous system.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34613973
    Citation
    Silva T, Queiroz JR, Turcio KHL, Tobelem DDC, Araujo TR, Coutinho KSL, Chavantes MC, Horliana ACRT, Deana AM, Silva DFTD, Castelo PM, Fernandes KPS, Motta LJ, Mesquita-Ferrari RA, Kalil Bussadori S. Effect of photobiomodulation combined with physical therapy on functional performance in children with myelomeningocele: A protocol randomized clinical blind study. PLoS One. 2021 Oct 6;16(10):e0253963. doi: 10.1371/journal.pone.0253963. eCollection 2021.
    Results Reference
    derived

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    Effects of Physical Therapy Associated With Photobiomodulation on Myelomeningocele

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