AutismPhase 1NCT01996800
Study of Chiropractic and Neuromuscular Reeducation as a Treatment for Autism Symptoms
A Phase 1 study testing Spinal Manipulative Therapy (SMT) and SMT and Neuromuscular Reeducation in people with Autism, run by Southern California University of Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Autism
- What is being tested?
- Spinal Manipulative Therapy (SMT) and SMT and Neuromuscular Reeducation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California University of Health Sciences
Whittier, California, 90604
About this study
Official title: The Effects of Spinal Manipulative Therapy and Neuromuscular Reeducation on the Presentation of Autistic Symptoms in Children
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.
Read the 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
- Conditions
- Autism
- Being tested
- Spinal Manipulative Therapy (SMT), SMT and Neuromuscular Reeducation
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Manipulative Therapy (SMT)Procedure or surgery
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 ReeducationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Manipulative Therapy (SMT) | Experimental | Patients will receive 12 weeks of chiropractic SMT Receives: 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. Receives: Procedure: Spinal Manipulative Therapy (SMT); Procedure: SMT and Neuromuscular Reeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 1, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Insufficient faculty and staff.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christos Korgan, PhD, Principal investigator, Southern California University of Health SciencesRochelle Neally, DC, Principal investigator, Southern California University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996800
- Sponsor's protocol ID
- SCU-AUT-01
- Status last verified
- Sep 2016
- First submitted
- 5 Nov 2013
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Spinal Manipulative Therapy and Neuromuscular Reeducation on the Presentation of Autistic Symptoms in Children
- ClinicalTrials.gov ID
- NCT01996800
- Acronym / sponsor ID
- SCU-AUT-01
- Conditions
- Autism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient faculty and staff.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Southern California University of Health SciencesUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Manipulative Therapy (SMT) | Experimental | Procedure: Spinal Manipulative Therapy (SMT)Patients will receive 12 weeks of chiropractic SMT |
| SMT and Neuromuscular Reeducation | Active comparator | Procedure: Spinal Manipulative Therapy (SMT), Procedure: SMT and Neuromuscular ReeducationSpinal 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. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | SMT and Neuromuscular Reeducation, Spinal Manipulative Therapy (SMT) |
| SMT and Neuromuscular ReeducationNeuromuscular 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. | Procedure or surgery | SMT and Neuromuscular Reeducation |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Insufficient faculty and staff.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christos Korgan, PhD principal investigator
Southern California University of Health Sciences
Rochelle Neally, DC principal investigator
Southern California University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Spinal Manipulative Therapy (SMT) and SMT and Neuromuscular Reeducation in people with Autism, run by Southern California University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient faculty and staff.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing change using the Autism Treatment Evaluation Checklist (time frame: Weeks 1, 6, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.