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Clinical Trials/NCT01996800
NCT01996800TerminatedPhase 1

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

Southern California University of Health Sciences1 site in 1 country8 target enrollmentStarted: August 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
8
Locations
1
Primary Endpoint
Assessing change using the Autism Treatment Evaluation Checklist

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
5 Years to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Spinal Manipulative Therapy (SMT)

Experimental

Patients will receive 12 weeks of chiropractic SMT

Intervention: Spinal Manipulative Therapy (SMT) (Procedure)

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.

Intervention: Spinal Manipulative Therapy (SMT) (Procedure)

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.

Intervention: SMT and Neuromuscular Reeducation (Procedure)

Outcomes

Primary Outcomes

Assessing change using the Autism Treatment Evaluation Checklist

Time Frame: Weeks 1, 6, and 12

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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