Pediatric Massage for Children With Autism Spectrum Disorder
NCT ID: NCT04220086
Last Updated: 2021-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
87 participants
INTERVENTIONAL
2021-05-30
2022-12-31
Brief Summary
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The Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS), Autism Treatment Evaluation Checklist (ATEC), Social Responsiveness Scale-Second Edition (SRS-2), Children's Sleep Habits Questionnaire (CSHQ) and Eysenck Personality Questionnaire (EPQ) will be used to assess the clinical behavioral changes of all participants, and to analyze the clinical effectiveness and safety of pediatric massage for children with ASD.
Electroencephalography (EEG) and brain functional near-infrared spectroscopy (fNIRS) will be recorded before and after treatment, to observe the potential brain target of pediatric massage for children with ASD.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pediatric massage
Children with ASD will receive pediatric massage for 12 weeks.
Pediatric massage therapy
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.
Usual care
Including Applied Behavior Analysis (ABA), Educational intervention, Interpersonal development intervention.
Waitlist control
Waitlist control
Usual care
Including Applied Behavior Analysis (ABA), Educational intervention, Interpersonal development intervention.
Healthy Control
15 healthy controls (age- and sex- matched with ASD patients) will be recruited. All of them will receive clinical evaluations, EEG and fNIRS detection.
No intervention
No intervention for healthy controls
Interventions
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Pediatric massage therapy
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.
Usual care
Including Applied Behavior Analysis (ABA), Educational intervention, Interpersonal development intervention.
No intervention
No intervention for healthy controls
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
3 Years
10 Years
ALL
No
Sponsors
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Shenzhen Children's Hospital
OTHER_GOV
The University of Hong Kong
OTHER
Responsible Party
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Prof. Zhang Zhang-Jin
Professor
Principal Investigators
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Zhang-Jin Zhang
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong-Shenzhen Hospital
Locations
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Shenzhen Children's Hospital
Shenzhen, Guangdong, China
Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TNASD1
Identifier Type: -
Identifier Source: org_study_id
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