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Assessment of Chiropractic Treatment Using Reaction and Response Times in Members of the Special Operation Forces (ACT2)

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ClinicalTrials.gov Identifier: NCT02168153
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborators:
Palmer College of Chiropractic
Samueli Institute for Information Biology
Information provided by (Responsible Party):
RAND

Brief Summary:
This study is a randomized controlled trial designed to evaluate changes in reaction times (RTs) and response times (RespTs) following chiropractic treatment compared to controls in the Special Forces Qualified (SFQ) population, including Special Operation Forces who are part of the 160th SOAR regiment on flight status.

Condition or disease Intervention/treatment Phase
Physiological Measurements of Response and Reaction Times Other: Chiropractic Manipulative Therapy Other: Wait-list Not Applicable

Detailed Description:

The Assessment of Chiropractic Treatment 2 (ACT2) assesses changes in reaction/response times following Chiropractic Manipulative Therapy (CMT) using a randomized controlled trial in members of SFQ or SOAR. This population is faced with simultaneous physiological and cognitive demands. The ability to give an accurate and appropriate motor response in a short time is required for successful completion of the types of missions they are expected to undertake.

It is possible that chiropractic care can improve performance in reaction and response times in populations that have low back pain and in populations that are asymptomatic. One possible theory for improvement, even in asymptomatic persons, is that they may have experienced an insult or stress to the body which is subclinical but alters their ability to function in an optimal manner. Thus a person may be asymptomatic and able to accomplish many activities in a normal manner, but when stressed to the limits of maximum capability, the effects of subclinical abnormalities may cause that person to function at a less than optimal level. If CMT is able to restore normal, more efficient mechanisms of functioning, it is therefore possible that the performance of challenging tasks could be improved.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Chiropractic Treatment Using Reaction and Response Times in Members of the Special Operation Forces (ACT2)
Study Start Date : August 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic

Arm Intervention/treatment
Active Comparator: Chiropractic Manipulative Therapy
Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.
Other: Chiropractic Manipulative Therapy
Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture.
Other Names:
  • Chiropractic Care
  • Spinal Manipulation

Placebo Comparator: Wait-List Control Group
Participants will complete questionnaires and biomechanical assessments
Other: Wait-list
Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits.




Primary Outcome Measures :
  1. Simple Reaction Time With the Dominant Hand [ Time Frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit ]
    Handedness of the participants will be determined on the basis of self-report. The subject will react to the appearance of visual prompts on the screen by pressing a button with the thumb of their dominant hand. A set consists of 11 prompts shown in sequence with a time period between the response to one prompt and the appearance of the next prompt ranging from 0.5 to 4.0 seconds in random order. The outcome variable for this test, the mean reaction time, is the average of the length of time between the appearance of each prompt and the press of the button in response to that prompt.

  2. Simple Reaction Time With the Dominant Foot [ Time Frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit ]
    This test will be done in a manner similar to that for the dominant hand except that the participants will press a pedal with their dominant foot.

  3. Choice Reaction Time [ Time Frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit ]
    Prompts on the screen will occur with the same time interval (1 second) in between the press of a button or pedal in response to one prompt and the appearance of the next prompt. Each prompt could be for either hand or either foot and the position of the prompt on the computer screen will indicate which thumb or foot should be used. If the wrong button or pedal is pressed, the software still goes on to the next prompt, but keeps track of how many incorrect responses were made. A set consists of a sequence of 41 prompts. The outcome variable for this test, mean reaction time, is the average length of time between each prompt's appearance and the participant's response.

  4. Response Time Involving the Dominant Hand (Fitts Law Test) [ Time Frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit ]
    Participants perform a computerized simple target acquisition task (a Fitts Law task) to investigate their response times using a mouse with their dominant hand. The participant will complete a block, a series of target selections on a computer monitor, by working through 32 trials. That is, 32 pairs of 'hits' - meaning the mouse was clicked when the cursor was inside each of two circles that appear on the screen. The measured outcome from this task will be the sum of the times required to complete each trial.

  5. Response Time Involving Whole Body Movement (T-wall) [ Time Frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit ]
    Participants will stand in front of the t-wall which is a commercially available device with a 4 x 8 foot bank of square buttons that are each 8 cm per side. When test is begun, one of the buttons lights up. The participant hits that button with either hand. The light inside that button then goes out and another button lights up until that one is hit. This process continues for a random sequence of 100 buttons. When last button is hit, all the buttons light up momentarily to indicate that the test is over. The measured outcome from this test is the time from when the first button is hit to when the last of the random sequence of 100 buttons is hit.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age range at least 20 years of age
  • Written informed consent
  • Active duty SFQ personnel or Special Operation Forces who are part of the 160th SOAR regiment on flight status stationed at the Ft. Campbell, KY military site

Exclusion Criteria:

  • Pain Intensity (NIH's PROMIS- question #29) > 4 at the Initial Visit
  • Additional diagnostic procedure needed (e.g. x-ray)
  • Bone and joint pathology contraindications for CMT. Potential participants with recent spinal fracture, concurrent spinal or paraspinal tumor(s), spinal or paraspinal infection(s), inflammatory arthropathies and significant osteoporosis will be referred for appropriate care.
  • Other contraindications for CMT (i.e., unstable spinal segments, cauda equina syndrome)
  • Currently being treated for traumatic brain injury (TBI)
  • Reasonable chance that within 2-4 weeks of initial participation they may be unable to complete the study, i.e., deployment, receive orders for a distant duty assignment or training site or otherwise be absent from the current military site over the study participation period.
  • Received care from a Doctor of Chiropractic within the past 30 days.
  • Pregnant or planning to become pregnant within 4 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168153


Locations
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United States, Kentucky
Blanchfield Army Community Hospital
Fort Campbell North, Kentucky, United States, 42223
Sponsors and Collaborators
RAND
Palmer College of Chiropractic
Samueli Institute for Information Biology
Investigators
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Principal Investigator: Ian Coulter, Ph.D RAND