Ignite Creation Date:
2024-05-06 @ 1:28 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04035863
Status:
UNKNOWN
Last Update Posted:
2019-07-29
First Post:
2019-07-24
Brief Title:
Effects of Photobiomodulation on Superficial Sensitivity and Muscle Activity of Individuals With Myelomeningocele
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
Official Title:
EVALUATION OF THE SENSORY-MOTOR RESPONSE IN PATIENTS WITH MYELOMENINGOCELE FOLLOWING TREATMENT WITH PHOTOBIOMODULATION
Status:
UNKNOWN
Status Verified Date:
2019-07
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 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 70 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 005
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