Study of Chiropractic and Neuromuscular Reeducation as a Treatment for Autism Symptoms

Autism Clinical Trial

Official title:

The Effects of Spinal Manipulative Therapy and Neuromuscular Reeducation on the Presentation of Autistic Symptoms in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01996800
• Other study ID #: SCU-AUT-01
• Status: Terminated
• Phase: Phase 1
• First received: November 5, 2013
• Last updated: September 30, 2016
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2016
• Source: Southern California University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Procedure:
• Spinal Manipulative Therapy (SMT)
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.
• SMT and Neuromuscular Reeducation
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.

Locations

Country	Name	City	State
United States	Southern California University of Health Sciences	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Southern California University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing change using the Autism Treatment Evaluation Checklist	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	No