Ignite Creation Date:
2024-05-06 @ 2:47 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04425330
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-06-06
Brief Title:
Effects of Physical Therapy Associated With Photobiomodulation on Myelomeningocele
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 randomizationcom 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None