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

NCT01996800 | Terminated Phase 1 DMC

• 1 other identifier: SCU-AUT-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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. 1.Spinal manipulative therapy (SMT) will reduce the presentation of autistic symptoms in children.
2. 2.Spinal manipulative therapy (SMT) in conjunction with neuromuscular reeducation will reduce the presentation of autistic symptoms in children.
3. 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.

Conditions

Autism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Spinal Manipulative Therapy (SMT)

EXPERIMENTAL

Patients will receive 12 weeks of chiropractic SMT

Procedure: Spinal Manipulative Therapy (SMT)

SMT and Neuromuscular Reeducation

ACTIVE COMPARATOR

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.

Procedure: Spinal Manipulative Therapy (SMT); Procedure: SMT and Neuromuscular Reeducation

Interventions

Spinal Manipulative Therapy (SMT) PROCEDURE

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; Spinal Manipulative Therapy (SMT)

SMT and Neuromuscular Reeducation PROCEDURE

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.

SMT and Neuromuscular Reeducation

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern California University of Health Sciences: lead

Study Sites (1)

Southern California University of Health Sciences

Whittier, California, 90604, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Christos Korgan, PhD

  Southern California University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Rochelle Neally, DC

  Southern California University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 27, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 4, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)