Physical Therapy ModalitiesNCT04425330
Effects of Physical Therapy Associated With Photobiomodulation on Myelomeningocele
A study testing physiotherapy exercises and PBM in people with Physical Therapy Modalities, run by University of Nove de Julho.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Physical Therapy Modalities
- What is being tested?
- physiotherapy exercises and PBM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2020to 3 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of myelomeningocele on the lower lumbar and sacral level;
- able to perform the movement of sitting and standing with support
Who cannot join
- 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.
About this study
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.
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
- Conditions
- Physical Therapy Modalities
- Being tested
- physiotherapy exercises, PBM, SHAM PBM
- Keywords
- Meningomyelocele, Low-Level Light Therapy, Photobiomodulation, Neurological Rehabilitation
- Medical subject headings
- Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapy exercisesOther
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.
PBMOther
Also called Low level laser therapy
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.
SHAM PBMOther
SHAM PBM
| Study group | Role | What they receive |
|---|---|---|
| physiotherapy exercises + PBM | Experimental | 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 Receives: Other: physiotherapy exercises; Other: PBM |
| physiotherapy exercises + SHAM PBM | Sham comparator | 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 Receives: Other: physiotherapy exercises; Other: SHAM PBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (5)
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.
Measured: 10 minutes
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.
Measured: 10 minutes
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.
Measured: 10 minutes
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.
Measured: 5 minutes
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.
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start3 Nov 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion3 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical Therapy ModalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425330
- Sponsor's protocol ID
- Mielomeningocele
- Status last verified
- Oct 2020
- First submitted
- 6 Jun 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34613973
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04425330
- Acronym / sponsor ID
- Mielomeningocele
- Conditions
- Physical Therapy Modalities
- Keywords
- Meningomyelocele, Low-Level Light Therapy, Photobiomodulation, Neurological Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 3 Nov 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 3 Feb 2022 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physiotherapy exercises + PBM | Experimental | Other: physiotherapy exercises, Other: PBMPhysiotherapy 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 + SHAM PBM | Sham comparator | Other: physiotherapy exercises, Other: SHAM PBMPhysiotherapy 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 |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of myelomeningocele on the lower lumbar and sacral level;
- able to perform the movement of sitting and standing with support
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapy exercisesThe 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. | Other | physiotherapy exercises + PBM, physiotherapy exercises + SHAM PBM |
| PBMAlso: Low level laser therapyPhotobiomodulation 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. | Other | physiotherapy exercises + PBM |
| SHAM PBMSHAM PBM | Other | physiotherapy exercises + SHAM PBM |
Primary outcome
Electromyography
Time frame: 30 minutes
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.
5 secondary outcomes
Sensory evaluation - monofilaments
Time frame: 10 minutes
Assessment of functional skills
Time frame: 10 minutes
Quality of life assessment
Time frame: 10 minutes
BDNF evaluation
Time frame: 5 minutes
Participation and Environment Measure
Time frame: 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 34613973Silva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy exercises and PBM in people with Physical Therapy Modalities, run by University of Nove de Julho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04425330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.