Bengali
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Pediatric Massage for Children With Autism Spectrum Disorder

কেবল নিবন্ধিত ব্যবহারকারীরা নিবন্ধগুলি অনুবাদ করতে পারবেন
প্রবেশ করুন - নিবন্ধন করুন
লিঙ্কটি ক্লিপবোর্ডে সংরক্ষিত হয়েছে
স্থিতিএখনও নিয়োগ হচ্ছে না
স্পনসর
The University of Hong Kong
সহযোগী
Shenzhen Children's Hospital

কীওয়ার্ডস

বিমূর্ত

This study was designed as a randomized controlled clinical trial of pediatric massage for children with Autism Spectrum Disorder (ASD). 72 ASD children will be recruited and randomly divided into two groups: the treatment group (pediatric massage + usual care, n=36) and the control group (usual care/waitlist group, n=36). Children in the treatment group will received 12 weeks pediatric massage by doctors and their own parents.
The Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS), 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.

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

Autism Spectrum Disorder

হস্তক্ষেপ / চিকিত্সা

Procedure: Pediatric massage

Procedure: Usual care

পর্যায়

-

বাহু গ্রুপ

বাহুহস্তক্ষেপ / 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 যোগ্যAll
স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করেহ্যাঁ
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]

ABC is a scale used for nonadaptive behaviors created to screen and indicate the probability of a diagnosis of autism. The questionnaire including 57 items related to five areas: sensorial, relational, use of body and objects, and social skills. Scale score> 67 strongly suggests the presence of autism. Changes in the ABC from baseline to endpoint will be observed. Assessments will be conducted at baseline and once every four weeks thereafter.

মাধ্যমিক ফলাফলের ব্যবস্থা

1. Changes in the Childhood Autism Rating Scale (CARS) [Baseline, 4 week, 8 week, 12 week]

CARS assesses the child on a scale from 1 to 4 in each of 15 dimensions or symptoms (including the ability to relate to people, emotional response, imitation, body use, object use, listening response, fear or nervousness, verbal communication, nonverbal communication, activity level, level and reliability of intellectual response, adaptation to changes, visual response, taste, smell and touch responses and general impressions). A total score of at least 30 strongly suggests the presence of autism. Children with score between 30 and 36 have mild-to-moderate autism while those with score between 37 and 60 have severe autism. Change in CARS from Baseline to Endpoint will be observed. Assessments will be conducted at baseline and once every four weeks thereafter.

2. Changes in the Social Responsiveness Scale - Second Edition (SRS-2) [Baseline, 4 week, 8 week, 12 week]

The Social Responsiveness Scale is a parent- and/or teacher-reported 65 question scale designed to measure social competence. Each question on the scale inquires about an observed aspect of reciprocal social behavior that is rated from "0" to "3", where 0 is best possible behavior and 3 is the worst possible behavior. The total SRS score may range from 0 to 195 where higher values represent the worse outcome. Assessments will be conducted at baseline and once every four weeks thereafter.

3. Changes in the Children's Sleep Habits Questionnaire (CSHQ) [Baseline, 4 week, 8 week, 12 week]

The Children's Sleep Habits Questionnaire (CSHQ) is a parental report sleep screening instrument designed for preschool- and school-aged children. The scale yields both a total score and 8 subscales reflecting the following sleep domains:1) bedtime resistance, 2) sleep onset delay, 3) sleep duration, 4) sleep anxiety, 5) night wakings, 6) parasomnias, 7) sleep-disordered breathing, 8) daytime sleepiness. Each item is answered with 1 of 3 markers: "usually" for 5 or more times a week, "sometimes" for 2-4 times a week, and "rarely" for never or 1 time a week. Higher scores reflect more disturbed sleep behavior. Assessments will be conducted at baseline and once every four weeks thereafter.

4. Changes in the Eysenck Personality Questionnaire (EPQ) - adult version [Baseline]

The EPQ is a three dimensional personality assessment tool to assess the personality traits of a person, including the Psychoticism (P), Extraversion (E), Neuroticism (N), and Lie (L) scales. Assessments will be conducted at baseline for parents to access parents' personality.

5. Changes in electroencephalography (EEG) [Baseline, 12 week]

EEG is a useful indicator of cortical connectivity between functional areas in the brain. Continuous resting-state electroencephalography (EEG) was recorded before and after the 12-week treatment and the delta (δ), theta (θ), alpha (α), beta (β) and gamma (γ) bands frequency will be used for EEG analysis.

6. Changes in functional near-infrared spectroscopy (fNIRS) of the brain [Baseline, 12 week]

Functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging procedure used to measure hemodynamic changes (oxyhemoglobin, deoxyhemoglobin and total haemoglobin), it will be measured at baseline and after the12-week treatment.

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]

Safety assessment. Adverse events that are related to treatment will be recorded once AE happens throughout the whole study. Adverse events rate will be assessed in all patients.

8. Number of participants with abnormal laboratory values in blood routine examination. [Baseline, 12 week]

Safety assessment. Blood routine examination (including RBC, WBC, Hb, HCT, PLT, MCV, MCH, MCHC, W-SCR, W-LCR, W-SCC, W-LCC, RDW-CV, PDW, and MPV levels) will be conducted before and after treatment to evaluate if there is infection or anemia. Number of participants with abnormal laboratory values will be recorded.

আমাদের ফেসবুক
পেজে যোগদান করুন

বিজ্ঞানের দ্বারা সমর্থিত সবচেয়ে সম্পূর্ণ completeষধি ভেষজ ডেটাবেস

  • 55 ভাষায় কাজ করে
  • বিজ্ঞানের সহায়তায় ভেষজ নিরাময়
  • ইমেজ দ্বারা ভেষজ স্বীকৃতি
  • ইন্টারেক্টিভ জিপিএস মানচিত্র - অবস্থানের উপর গুল্ম ট্যাগ করুন (শীঘ্রই আসছে)
  • আপনার অনুসন্ধান সম্পর্কিত বৈজ্ঞানিক প্রকাশনা পড়ুন
  • তাদের প্রভাব দ্বারা herষধি গুল্মগুলি অনুসন্ধান করুন Search
  • আপনার আগ্রহগুলি সংগঠিত করুন এবং নিউজ রিসার্চ, ক্লিনিকাল ট্রায়াল এবং পেটেন্টগুলির সাথে আপ ডেট থাকুন

একটি লক্ষণ বা একটি রোগ টাইপ করুন এবং এমন গুল্মগুলি সম্পর্কে পড়ুন যা সহায়তা করতে পারে, একটি bষধি টাইপ করতে পারে এবং এর বিরুদ্ধে ব্যবহৃত রোগ এবং লক্ষণগুলি দেখতে পারে।
* সমস্ত তথ্য প্রকাশিত বৈজ্ঞানিক গবেষণার উপর ভিত্তি করে

Google Play badgeApp Store badge