Clinical trial NCT01996800: Study of Chiropractic and Neuromuscular Reeducation as a Treatment for Autism Symptoms
Official title: The Effects of Spinal Manipulative Therapy and Neuromuscular Reeducation on the Presentation of Autistic Symptoms in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Autism
Lead sponsor: Southern California University of Health Sciences
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 8
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study explores the effectiveness of chiropractic and neuromuscular reeducation as complementary and alternative medicine treatment approaches for autism. Our investigation maintains the following three hypotheses:

1. Spinal manipulative therapy (SMT) will reduce the presentation of autistic symptoms in children.
2. Spinal manipulative therapy (SMT) in conjunction with neuromuscular reeducation will reduce the presentation of autistic symptoms in children.
3. The presentation of autistic symptoms in children will significantly differ between the treatment groups of spinal manipulative therapy and spinal manipulative therapy in unification with neuromuscular reeducation.

Detailed description: We aim to describe and illustrate the roles of spinal manipulative therapy and neuromuscular reeducation in autistic children at a CAM university health center with regard to the following:

1. To measure the safety and efficacy of spinal manipulative therapy for the autism spectrum disorders
2. To measure the safety and efficacy of spinal manipulative therapy and neuromuscular reeducation for the treatment of the autism spectrum disorders
3. To begin to establish or debunk debated SMT treatment for autism
4. To evaluate, gauge, and improve current autism assessment tools by exploring face validity of the measures as indicated by ongoing data collection

Eligibility criteria: Inclusion Criteria:

* Children diagnosed by a physician with an Autism Spectrum Disorder between the ages of 5 and 15
* Children with parents able to bring their child to the university health center two times a week for 12 weeks
* Children assessed to have a level of functioning that is conducive to experiencing and undergoing chiropractic treatment at the university health center.
* Children without the presentation and diagnosis of comorbidity

Exclusion Criteria:

* Children with comorbidity or multiple diagnoses (mental retardation, chromosomal disorders)
* Children undergoing another treatment for their disorder, other than a form of behavioral therapy (ABA or DTT) by a trained or licensed mental health professional.
* Children taking medication that is not deemed to be stabilized by a primary care physician, including medication dosages that is likely to be shifted and changed during the 12 weeks of treatment in this investigation.
* Children assessed to have severe behavioral impediments not conducive to chiropractic treatment at the university health center.

Primary outcomes:
measure: Assessing change using the Autism Treatment Evaluation Checklist
timeFrame: Weeks 1, 6, and 12
Secondary outcomes:
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Southern California University of Health Sciences
state: California
Study officials:
affiliation: Southern California University of Health Sciences
name: Christos Korgan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern California University of Health Sciences
name: Rochelle Neally, DC
role: PRINCIPAL_INVESTIGATOR
References: