Photobiomodulation on Core Symptoms of Autism

Официальное название

Efficacy of Photobiomodulation on Core Symptoms of Autism

Обзор

This study aims to evaluate the effectiveness of photobiomodulation therapy on core symptoms in children with autism spectrum disorder. Participants will receive designed physical therapy, occupational therapy and speech program in addition to Photobiomodulation over a defined period. Out comes will be assessed using standardized clinical scales to determine improvements in social interactions, communication and behavior.

Подробное описание

Autism spectrum disorder (ASD) is a complex neurodevelopmental condition typically characterized by social and communicative problems as well as repetitive patterns of behaviour. Photobiomodulation is non-invasive exposure of light, typically within the red to near-infrared spectrum, to elicit physiological effects across several tissue systems. This study is designed as a randomized controlled trial to assess the effect of Photobiomodulation on core symptoms of autism spectrum disorder. Participants will be recruited from outpatient clinic of faculty of physical therapy at Cairo University. The intervention protocol includes that the child is in supine lying position with eyes covered with sheet. Each participant started with a 2 min treatment. Participants who tolerated the treatment well received incrementally larger doses (2 min) in each of 5 subsequent sessions, for a maximum dose of 12 min. Two groups of children each received a random assignment. after being selected from outpatient clinic of faculty of physical therapy. Both groups (A and B) participated in physical treatment for three months; group A had designed physical therapy, occupational therapy and speech program, whereas group B had the same designed physical therapy, occupational therapy and speech program in addition to Photobiomodulation.

Ethical considerations:

This study has been reviewed and approved by Institutional Review Board / Ethics Committee via the Faculty of Physical Therapy Research Ethics Officer. Written informed consent will be obtained from all participants before enrollment.

Вмешательства

• Устройство Photobiomodulation
  non-invasive exposure of light, typically within the red to near-infrared (\~λ = 600-1300 nm) spectrum, to elicit physiological effects across several tissue systems. The application will be transcranial with distance of 50 cm above the head. The child is in supine lying position with eyes covered with sheet

Первичные конечные точки

• Improvement in core symptoms of autism [Срок оценки: Baseline and after 3 months of intervention]
• Improvement in sensory profile [Срок оценки: Baseline and after 3 months of intervention]

Критерии участия

Критерии включения

• Children with autism spectrum disorders (ASD).
• Their age ranged from 2 to 6 years

Критерии исключения

• Children having epileptogenic seizures.
• Mentally retarded children.
• Children with genetic syndromes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07542899 · photobiomodulation on autism

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗