- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01996800
Study of Chiropractic and Neuromuscular Reeducation as a Treatment for Autism Symptoms
The Effects of Spinal Manipulative Therapy and Neuromuscular Reeducation on the Presentation of Autistic Symptoms in Children
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:
- Spinal manipulative therapy (SMT) will reduce the presentation of autistic symptoms in children.
- Spinal manipulative therapy (SMT) in conjunction with neuromuscular reeducation will reduce the presentation of autistic symptoms in children.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- To measure the safety and efficacy of spinal manipulative therapy for the autism spectrum disorders
- To measure the safety and efficacy of spinal manipulative therapy and neuromuscular reeducation for the treatment of the autism spectrum disorders
- To begin to establish or debunk debated SMT treatment for autism
- To evaluate, gauge, and improve current autism assessment tools by exploring face validity of the measures as indicated by ongoing data collection
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Whittier, California, United States, 90604
- Southern California University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Spinal Manipulative Therapy (SMT)
Patients will receive 12 weeks of chiropractic SMT
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Spinal manipulation is a therapeutic intervention performed on spinal articulations which are synovial joints.
These articulations in the spine that are amenable to spinal manipulative therapy include the z-joints, the atlanto-occipital, atlanto-axial, lumbosacral, sacroiliac, costotransverse and costovertebral joints.
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ACTIVE_COMPARATOR: SMT and Neuromuscular Reeducation
Spinal manipulation is a therapeutic intervention performed on spinal articulations which are synovial joints. These articulations in the spine that are amenable to spinal manipulative therapy include the z-joints, the atlanto-occipital, atlanto-axial, lumbosacral, sacroiliac, costotransverse and costovertebral joints. A neuromuscular re-education program will consist of repetitive movements, posturing, and stimulation designed to reinforce nerve signals for functional movements. It is theorized that when the nerve signals are "retrained" and appropriate muscle movements are repeated, movement patterns become automatic again. Neuromuscular re-education is usually done along with other types of treatment to promote functional muscle movement. |
Spinal manipulation is a therapeutic intervention performed on spinal articulations which are synovial joints.
These articulations in the spine that are amenable to spinal manipulative therapy include the z-joints, the atlanto-occipital, atlanto-axial, lumbosacral, sacroiliac, costotransverse and costovertebral joints.
Neuromuscular reeducation is a general term that refers to techniques that attempt to retrain the neuromuscular system to function properly.
The basis of this idea is that the formation of certain patterns of communication between muscles and nerves allow people to perform simple everyday acts such as climbing stairs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing change using the Autism Treatment Evaluation Checklist
Time Frame: Weeks 1, 6, and 12
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Please see: Rimland, B., & Edelson, S. M. (2000). Autism treatment evaluation checklist (ATEC). Retrieved October, 23, 2006. Volkmar, F. R., Cicchetti, D. V., Dykens, E., Sparrow, S. S., Leckman, J. F., & Cohen, D. J. (1988). An evaluation of the autism behavior checklist. Journal of Autism and Developmental Disorders, 18(1), 81-97. |
Weeks 1, 6, and 12
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Collaborators and Investigators
Investigators
- Principal Investigator: Christos Korgan, PhD, Southern California University of Health Sciences
- Principal Investigator: Rochelle Neally, DC, Southern California University of Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCU-AUT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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