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

Primary Purpose

Autism

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Spinal Manipulative Therapy (SMT)
SMT and Neuromuscular Reeducation
Sponsored by
Southern California University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southern California University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal Manipulative Therapy (SMT)

SMT and Neuromuscular Reeducation

Arm Description

Patients will receive 12 weeks of chiropractic 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. 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2013
Last Updated
September 30, 2016
Sponsor
Southern California University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01996800
Brief Title
Study of Chiropractic and Neuromuscular Reeducation as a Treatment for Autism Symptoms
Official Title
The Effects of Spinal Manipulative Therapy and Neuromuscular Reeducation on the Presentation of Autistic Symptoms in Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Insufficient faculty and staff.
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern California University of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Manipulative Therapy (SMT)
Arm Type
Experimental
Arm Description
Patients will receive 12 weeks of chiropractic SMT
Arm Title
SMT and Neuromuscular Reeducation
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Spinal Manipulative Therapy (SMT)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
SMT and Neuromuscular Reeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessing change using the Autism Treatment Evaluation Checklist
Description
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.
Time Frame
Weeks 1, 6, and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christos Korgan, PhD
Organizational Affiliation
Southern California University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rochelle Neally, DC
Organizational Affiliation
Southern California University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California University of Health Sciences
City
Whittier
State/Province
California
ZIP/Postal Code
90604
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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