Trial record 14 of 25 for:    Open Studies | chiropractic

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

This study is currently recruiting participants.
Verified November 2013 by Southern California University of Health Sciences
Sponsor:
Information provided by (Responsible Party):
Southern California University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01996800
First received: November 5, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.

Condition Intervention Phase
Autism
Procedure: Spinal Manipulative Therapy (SMT)
Procedure: SMT and Neuromuscular Reeducation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Spinal Manipulative Therapy and Neuromuscular Reeducation on the Presentation of Autistic Symptoms in Children

Resource links provided by NLM:


Further study details as provided by Southern California University of Health Sciences:

Primary Outcome Measures:
  • Assessing change using the Autism Treatment Evaluation Checklist [ Time Frame: Weeks 1, 6, and 12 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 120
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spinal Manipulative Therapy (SMT)
Patients will receive 12 weeks of chiropractic SMT
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.
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.

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.
Procedure: 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.

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

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01996800

Contacts
Contact: Christos Korgan (562)902-3369 ext 5 christoskorgan@scuhs.edu

Locations
United States, California
Southern California University of Health Sciences Recruiting
Whittier, California, United States, 90604
Contact: Christos Korgan, Ph.D.    562-902-3369 ext 5      
Principal Investigator: Rochelle Neally, D.C.         
Sub-Investigator: Christos Korgan, Ph.D.         
Sponsors and Collaborators
Southern California University of Health Sciences
Investigators
Principal Investigator: Christos Korgan, PhD Southern California University of Health Sciences
Principal Investigator: Rochelle Neally, DC Southern California University of Health Sciences
  More Information

No publications provided

Responsible Party: Southern California University of Health Sciences
ClinicalTrials.gov Identifier: NCT01996800     History of Changes
Other Study ID Numbers: SCU-AUT-01
Study First Received: November 5, 2013
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014