Pediatric Massage for Children With Autism Spectrum Disorder
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social interactions and communication skills, both verbal and non-verbal, restricted interests, and stereotypical behaviors. However, at present, there is no drug has proven effective in alleviating the core symptoms of social and communication difficulties in ASD.
ASD families are becoming turn to complementary and alternative medicine (CAM). They use CAM to treat symptoms of autism in general, comorbid symptoms (such as attention, hyperactivity, irritability, moodiness, gastrointestinal symptoms, seizures, sleep and tactile sensitivity). In addition, some families report that the use of CAM has less negative side effects compared with conventional treatments.
As a traditional TCM therapy, pediatric massage has been used in treating various pediatric diseases including ASD. A large number of clinical studies have shown that pediatric massage can improve ASD and its accompanied symptoms effectively. However, its exact effectiveness and mechanism need to be further explored.
In the proposed study, pediatric massage will be employed to treat children with ASD, to confirm the effectiveness and safety of pediatric massage therapy for children with ASD, and to explore the potential mechanism and target of pediatric massage for ASD.
তারিখ
সর্বশেষ যাচাই করা হয়েছে: | 12/31/2019 |
প্রথম জমা দেওয়া: | 10/26/2019 |
আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 01/05/2020 |
প্রথম পোস্ট: | 01/06/2020 |
সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 01/05/2020 |
সর্বশেষ আপডেট পোস্ট: | 01/06/2020 |
আসল অধ্যয়ন শুরুর তারিখ: | 06/30/2020 |
আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 06/29/2022 |
আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 12/30/2022 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Procedure: Pediatric massage
Procedure: Usual care
পর্যায়
বাহু গ্রুপ
বাহু | হস্তক্ষেপ / চিকিত্সা |
---|---|
Experimental: Pediatric massage Children with ASD will receive pediatric massage for 12 weeks. | Procedure: Pediatric massage Children with ASD will receive pediatric massage therapy twice a week for 12 consecutive weeks by professional pediatric massage doctor. In addition, they will receive parent provided pediatric massage therapy at home after their parents received the professional pediatric massage therapy training. The frequency of pediatric massage will not be more than once every day and each session last about 30 minutes. |
Sham Comparator: Waitlist control Waitlist control |
যোগ্যতার মানদণ্ড
বয়স অধ্যয়নের জন্য যোগ্য | 3 Years প্রতি 3 Years |
লিঙ্গ অধ্যয়নের জন্য যোগ্য | All |
স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
নির্ণায়ক | Inclusion Criteria: 1. Autism Spectrum Disorder (ASD) has been diagnosed and a diagnosis certificate has been provided. The diagnostic criteria is based on the Diagnostic and Statistical Manual of Mental Disorders fifth version (DSM-V) criteria of Autism Spectrum Disorder. Score of CARS≥30; 2. Aged 3-10, right-handedness ; 3. The parents (or other legal guardians) of participants to give consent and to cooperate with the treatment and data collection. Exclusion Criteria: 1. The conventional treatment accepted currently does not belong to the following three categories: Applied Behavior Analysis (ABA), Educational intervention or Interpersonal development intervention; 2. Patients with any major treatment changes within 4 weeks prior to joining the study; 3. Patients or their parents with other neurodevelopmental disorders, severe psychiatric diseases, genetic disease, or other severe systemic disease (such as history of severe head trauma, or stroke); 4. Seizure within the last year prior to enrolment, or the need for seizure medications either at present or in the past; 5. Being involved in other clinical trials; 6. Patients received pediatric massage therapy in the past two months, or are receiving pediatric massage; 7. During the study period, parents will be required not to initiate any new interventions or modify current interventions unless absolutely necessary. If a change must be made, the parent is required to inform investigator, who decides whether the subject should stop participating in the study based on situation. |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. Changes in the Autism Behavior Checklist (ABC) [Baseline, 4 week, 8 week, 12 week, and follow-up assessment at the week of 4, 8, 12 after treatment]
মাধ্যমিক ফলাফলের ব্যবস্থা
1. Changes in the Childhood Autism Rating Scale (CARS) [Baseline, 4 week, 8 week, 12 week]
2. Changes in the Social Responsiveness Scale - Second Edition (SRS-2) [Baseline, 4 week, 8 week, 12 week]
3. Changes in the Children's Sleep Habits Questionnaire (CSHQ) [Baseline, 4 week, 8 week, 12 week]
4. Changes in the Eysenck Personality Questionnaire (EPQ) - adult version [Baseline]
5. Changes in electroencephalography (EEG) [Baseline, 12 week]
6. Changes in functional near-infrared spectroscopy (fNIRS) of the brain [Baseline, 12 week]
7. Number of participants with non-serious and serious adverse events (AEs) [1,2,3,4,5,6,7,8,9,10,11,12 weeks]
8. Number of participants with abnormal laboratory values in blood routine examination. [Baseline, 12 week]