Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536751
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Therapeutic Photobiomodulation and Tretament of Spasticity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Photobiomodulation in the Treatment of Spasticity in Children With Cerebral Palsy A Controlled Randomized Blind Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cerebral palsy is a non-progressive permanent syndrome that occurs in childhood and is accompanied by motor tônus and posture disorders Its etiology is related to an insult or damage to the central nervous system in maturation Approximately 80 of cerebral palsy course with spasticity which when left untreated will generate pain and functional anatomical and structural changes with a negative impact Photobiomodulation therapy has biological effects of tissue regeneration muscle relaxation vasodilation reduction of the inflammatory process and relief of pain symptoms already described in the literature in addition to being feasible practical safe without side effects painless and non-invasiveThis study is a blind randomized and controlled clinical trial that will evaluate the effect of photobiomodulation in reducing gastrocnemius muscle spasticity in children aged 2 to 18 years diagnosed with spastic cerebral palsy of lower limbs of any etiology for at least 03 months and randomized into two groups application of Low Intensity LED Therapy in the medial and right lateral gastrocnemius muscles device power of 100mW wavelength of 850nm energy of 3Jcm2point once a week making 08 therapeutic days during 02 months or placebo group Low-Intensity LED Therapy same device turned off Both groups will also receive the standard treatment for spasticity To assess the response to therapy the outcomes evaluated will be the modified Ashworth Scale the Mobility Domain of Pediatric evaluation of disability inventory the Gross Motor Function Classification System scale and passive and active range of motion of the ankle analyzed at the pré and post each therapeutic session and in the pre and post therapeutic period of 08 sessions
Detailed Description:
Cerebral palsy is a non-progressive permanent syndrome that occurs in childhood and is accompanied by motor tonus and posture disorders Its etiology is related to an insult or damage to the central nervous system in maturation during the prenatal perinatal or postnatal period when the central nervous system has not yet fully developed
Approximately 80 of cerebral palsy course with spasticity which when left untreated will generate pain and functional anatomical and structural changes in bones joints muscles tendons and nerve junctions with a negative impact on quality of life social participation and functionality of this individual In parallel photobiomodulation therapy has biological effects of tissue regeneration muscle relaxation vasodilation reduction of the inflammatory process and relief of pain symptoms already described in the literature in addition to being feasible practical safe without side effects painless and non-invasiveObjectives and methods this study is a pilot double-blind randomized and controlled clinical trial that will evaluate the effect of photobiomodulation in reducing gastrocnemius muscle spasticity in 28 children aged 2 to 18 years diagnosed with spastic cerebral palsy of right lower limb of any etiology for at least 03 months selected at the
Physiotherapy Service of Universidade Nove de Julho and randomized into two groups
application of Low Intensity LED Therapy in the medial and right lateral gastrocnemius muscles device power of 100mW wavelength of 850nm energy of 15 Jpoint applied in 02 points per muscle for 15 seconds frequency of once a week making 8 therapeutic days or placebo group Low-Intensity LED Therapy same device turned off Patients with fixed anatomical deformity of the ankle with less than 90 degrees of dorsiflexion amplitude malnutrition severe gastroesophageal reflux disease and another type of associated movement disorder will be excluded Both groups will also receive the standard treatment for spasticity performed by the hospitals rehabilitation health team
To assess the response to therapy the outcomes evaluated will be the modified Ashworth Scale MAS the Mobility Domain of Pediatric Evaluation of Disability Inventory for children PEDI the Gross Motor Function Classification System scale GMFCS and passive range of motion ROM of the ankle analyzed at the end of each therapeutic session and in the pre therapeutic period of 08 weeeks Epidemiological data will be collected from the medical records of participants in the physiotherapy for characterizing the sample age genderetiology of brain injury and type of paralysis injury time medications comorbidities previous surgeries length of physiotherapy treatment at the start of the study description of the physiotherapy treatment in use use of a walking aid or orthosis Data will be statistically analyzed and positive or negative results reported and discussed
Approximately 80 of cerebral palsy course with spasticity which when left untreated will generate pain and functional anatomical and structural changes in bones joints muscles tendons and nerve junctions with a negative impact on quality of life social participation and functionality of this individual In parallel photobiomodulation therapy has biological effects of tissue regeneration muscle relaxation vasodilation reduction of the inflammatory process and relief of pain symptoms already described in the literature in addition to being feasible practical safe without side effects painless and non-invasiveObjectives and methods this study is a pilot double-blind randomized and controlled clinical trial that will evaluate the effect of photobiomodulation in reducing gastrocnemius muscle spasticity in 28 children aged 2 to 18 years diagnosed with spastic cerebral palsy of right lower limb of any etiology for at least 03 months selected at the
Physiotherapy Service of Universidade Nove de Julho and randomized into two groups
application of Low Intensity LED Therapy in the medial and right lateral gastrocnemius muscles device power of 100mW wavelength of 850nm energy of 15 Jpoint applied in 02 points per muscle for 15 seconds frequency of once a week making 8 therapeutic days or placebo group Low-Intensity LED Therapy same device turned off Patients with fixed anatomical deformity of the ankle with less than 90 degrees of dorsiflexion amplitude malnutrition severe gastroesophageal reflux disease and another type of associated movement disorder will be excluded Both groups will also receive the standard treatment for spasticity performed by the hospitals rehabilitation health team
To assess the response to therapy the outcomes evaluated will be the modified Ashworth Scale MAS the Mobility Domain of Pediatric Evaluation of Disability Inventory for children PEDI the Gross Motor Function Classification System scale GMFCS and passive range of motion ROM of the ankle analyzed at the end of each therapeutic session and in the pre therapeutic period of 08 weeeks Epidemiological data will be collected from the medical records of participants in the physiotherapy for characterizing the sample age genderetiology of brain injury and type of paralysis injury time medications comorbidities previous surgeries length of physiotherapy treatment at the start of the study description of the physiotherapy treatment in use use of a walking aid or orthosis Data will be statistically analyzed and positive or negative results reported and discussed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None