Cognition - OtherNCT02749266
The Impact of Chiropractic Activator Adjustments on Mental Rotation and Line Judgment Reaction Time
A study testing Chiropractic adjustment in people with Cognition - Other, run by Life University at 1 site in United States.
Trial summary
The purpose of this pilot study will be to assess the impact of chiropractic Activator adjustments on spatial cognitive abilities through initial assessment and testing in a healthy population aged 18 to 35. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition - Other
- What is being tested?
- Chiropractic adjustment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Aug 2014
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 35
- In good health
Who cannot join
- pregnant
- medically diagnosed cognitive deficits
- medically diagnosed learning disabilities
- fractures, traumas, or surgeries to the spine within the past six months
- diagnosed osteoporosis, articular instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Chiropractic Activator Adjustments on Mental Rotation and Line Judgment Reaction Time: A Pilot Study
The purpose of this pilot study will be to assess the impact of chiropractic Activator adjustments on spatial cognitive abilities through initial assessment and testing in a healthy population aged 18 to 35.
Read the detailed description
This study seeks to assess the impact of chiropractic on cognition. Participants must be between 18 and 35 years of age. Within the past six months individuals may not participate if they have had any broken bones, accidents, or surgeries to their spine. Additionally, participants cannot have any mental disabilities, be pregnant, or have other conditions of the spine such as bone mineral loss.
Patients will receive a chiropractic exam and will be randomized to a sham (simulated chiropractic adjustment) or chiropractic adjustment intervention group. Prior to receiving either the sham or chiropractic adjustment, the participants will sit in front of a computer screen and will be asked to follow instructions and press a button on a keypad. There will be three different types of computer assessments that will take approximately fifteen minutes total. After the computer assessments the participant will receive either the sham or chiropractic adjustment. The chiropractic adjustment and the sham will both utilize a handheld instrument called an Activator. After the adjustment or sham the participant will take the computer assessments again. The total time this may take is ninety minutes.
- Conditions
- Cognition - Other
- Being tested
- Chiropractic adjustment, Sham chiropractic adjustment
- Keywords
- chiropractic, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic adjustmentOther
Also called Chiropractic Activator adjustment, Chiropractic manipulation
Participant will receive a chiropractic adjustment utilizing a handheld chiropractic instrument called an Activator.
Sham chiropractic adjustmentOther
Also called Sham manipulation
Participants will receive a simulated chiropractic adjustment with a handheld adjusting instrument called an Activator.
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic Activator Adjustment | Experimental | Participant will receive a chiropractic adjustment utilizing a handheld chiropractic instrument called an Activator. Receives: Other: Chiropractic adjustment |
| Chiropractic sham adjustment | Sham comparator | Participant will receive a sham (simulated) chiropractic adjustment utilizing a handheld chiropractic instrument called an Activator. Receives: Other: Sham chiropractic adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time
Reaction time assessment of keyboard responses to computerized stimulus presentations
Measured: Pre and Post intervention (average of 90 minutes)
Secondary outcomes (1)
Response correctness
Correct response to computerized stimulus presentations
Measured: Pre and post intervention (average of 90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition - OtherStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Georgia
- Responsible party
- Sponsor
- Investigators
- Stephanie Sullivan, D.C., Principal investigator, Life University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749266
- Sponsor's protocol ID
- I-0011
- Status last verified
- Apr 2016
- First submitted
- 18 Jul 2014
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chiropractic Activator Adjustments on Mental Rotation and Line Judgment Reaction Time: A Pilot Study
- ClinicalTrials.gov ID
- NCT02749266
- Acronym / sponsor ID
- I-0011
- Conditions
- Cognition - Other
- Keywords
- chiropractic, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Collaborators
- University of Georgia
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Apr 2016 (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.
The purpose of this pilot study will be to assess the impact of chiropractic Activator adjustments on spatial cognitive abilities through initial assessment and testing in a healthy population aged 18 to 35.
Detailed description
This study seeks to assess the impact of chiropractic on cognition. Participants must be between 18 and 35 years of age. Within the past six months individuals may not participate if they have had any broken bones, accidents, or surgeries to their spine. Additionally, participants cannot have any mental disabilities, be pregnant, or have other conditions of the spine such as bone mineral loss.
Patients will receive a chiropractic exam and will be randomized to a sham (simulated chiropractic adjustment) or chiropractic adjustment intervention group. Prior to receiving either the sham or chiropractic adjustment, the participants will sit in front of a computer screen and will be asked to follow instructions and press a button on a keypad. There will be three different types of computer assessments that will take approximately fifteen minutes total. After the computer assessments the participant will receive either the sham or chiropractic adjustment. The chiropractic adjustment and the sham will both utilize a handheld instrument called an Activator. After the adjustment or sham the participant will take the computer assessments again. The total time this may take is ninety minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic Activator Adjustment | Experimental | Other: Chiropractic adjustmentParticipant will receive a chiropractic adjustment utilizing a handheld chiropractic instrument called an Activator. |
| Chiropractic sham adjustment | Sham comparator | Other: Sham chiropractic adjustmentParticipant will receive a sham (simulated) chiropractic adjustment utilizing a handheld chiropractic instrument called an Activator. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 to 35
- In good health
Key exclusion criteria (5 listed)
- pregnant
- medically diagnosed cognitive deficits
- medically diagnosed learning disabilities
- fractures, traumas, or surgeries to the spine within the past six months
- diagnosed osteoporosis, articular instability
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 |
|---|---|---|
| Chiropractic adjustmentAlso: Chiropractic Activator adjustment, Chiropractic manipulationParticipant will receive a chiropractic adjustment utilizing a handheld chiropractic instrument called an Activator. | Other | Chiropractic Activator Adjustment |
| Sham chiropractic adjustmentAlso: Sham manipulationParticipants will receive a simulated chiropractic adjustment with a handheld adjusting instrument called an Activator. | Other | Chiropractic sham adjustment |
Primary outcome
Reaction time
Time frame: Pre and Post intervention (average of 90 minutes)
Reaction time assessment of keyboard responses to computerized stimulus presentations
1 secondary outcome
Response correctness
Time frame: Pre and post intervention (average of 90 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
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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.
Stephanie Sullivan, D.C. principal investigator
Life University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic adjustment in people with Cognition - Other, run by Life University 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 22 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reaction time (time frame: Pre and Post intervention (average of 90 minutes)). 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 22 Apr 2016.