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临床试验/NCT07542899
NCT07542899尚未招募不适用

Efficacy of Photobiomodulation on Core Symptoms of Autism

Suez University0 个研究点目标入组 30 人开始时间: 2026年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
Improvement in core symptoms of autism

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Photobiomodulation Group

Experimental

干预措施: Photobiomodulation (Device)

control group

No Intervention

结局指标

主要结局

Improvement in core symptoms of autism

时间窗: Baseline and after 3 months of intervention

Assessment of changes in core autism symptoms using the Childhood Autism Rating Scale.The scale ranges from 15 to 60 , with higher scores indicating more severe autism symptoms (worse out come).

Improvement in sensory profile

时间窗: Baseline and after 3 months of intervention

Assessment of a child's sensory processing patterns using the Sensory Profile 2. The Sensory Profile 2 is a standardized caregiver questionnaire that evaluates sensory processing across multiple domains. Scores are categorized into performance ranges (e.g., "Much Less Than Others", "Less Than Others," Just Like the Majority of Others," "More Than Others," "Much More Than Others") , with deviations from the typical range indicating greater sensory processing difficulties (worse outcome).

次要结局

未报告次要终点

研究者

发起方
Suez University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya salah el din fouad rostom

Lecturer of physical therapy for general surgery, Burn and skin, Suez university, Suez ,Egypt

Suez University

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