Heart RateNCT00380341
Effects of Instrument-Applied Spinal Manipulative Therapy on Postureal Control and Autonomic Balance
A study testing Instrument-applied spinal manipulative therapy in people with Heart Rate, run by Logan College of Chiropractic.
Trial summary
The purpose of this study is to determine the effects of spinal manipulative therapy on autonomic balance and to determine if there exists a relationship between autonomic state and postural control. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate
- What is being tested?
- Instrument-applied spinal manipulative therapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Nov 2006
- 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults currently enrolled at Logan College
Who cannot join
- Lower extremity injury, vestibular disorders
About this study
The purpose of this study is to determine the effects of spinal manipulative therapy on autonomic balance and to determine if there exists a relationship between autonomic state and postural control.
Read the detailed description
Previous studies have demonstrated that sensory and cognitive systems share some common neural substrate. The afferent neural impuleses of mechanoreception (also known as somatosensation) as produced by joint mechanoreceptors and adjacent muscle spindle cells may impact supraspinal centers. Few studies have been done to determine if the afferent impulses generated by spinal manipulative therapy (SMT) can impact the porcessing that occurs at supra-spinal centers. The relationship between postural control and cognition is studies using a dual-tak methodology, a primary (postural) task will often demonstrate degradation with the addition of a secondary, concurrent (cognitive) task. The current study seeks to determine the effects of SMT on postrual control using a dual-task paradigm, while monitoring autonomic state (using Heart Rate Variability analysis) during the course of therapy. It is thought that SMT can improve HRV status, and postural control within a dual-task situation, and that there will be differences in postural control related to a participant's HRV status. Activities of daily living often invole the coupling of a cognitive task with a complex postural task.
- Conditions
- Heart Rate
- Being tested
- Instrument-applied spinal manipulative therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument-applied spinal manipulative therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startSep 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart RateStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Investigators
- Kristan J. Giggey, DC, Principal investigator, Logan College of ChiropracticRodger Tepe, PhD, Study director, Logan College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380341
- Sponsor's protocol ID
- RD0803050033
- Status last verified
- Oct 2008
- First submitted
- 21 Sep 2006
- Last updated
- 17 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Instrument-Applied Spinal Manipulative Therapy on Postureal Control and Autonomic Balance
- ClinicalTrials.gov ID
- NCT00380341
- Acronym / sponsor ID
- RD0803050033
- Conditions
- Heart Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Nov 2006
- First posted
- 25 Sep 2006 (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 study is to determine the effects of spinal manipulative therapy on autonomic balance and to determine if there exists a relationship between autonomic state and postural control.
Detailed description
Previous studies have demonstrated that sensory and cognitive systems share some common neural substrate. The afferent neural impuleses of mechanoreception (also known as somatosensation) as produced by joint mechanoreceptors and adjacent muscle spindle cells may impact supraspinal centers. Few studies have been done to determine if the afferent impulses generated by spinal manipulative therapy (SMT) can impact the porcessing that occurs at supra-spinal centers. The relationship between postural control and cognition is studies using a dual-tak methodology, a primary (postural) task will often demonstrate degradation with the addition of a secondary, concurrent (cognitive) task. The current study seeks to determine the effects of SMT on postrual control using a dual-task paradigm, while monitoring autonomic state (using Heart Rate Variability analysis) during the course of therapy. It is thought that SMT can improve HRV status, and postural control within a dual-task situation, and that there will be differences in postural control related to a participant's HRV status. Activities of daily living often invole the coupling of a cognitive task with a complex postural task.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults currently enrolled at Logan College
Key exclusion criteria (1 listed)
- Lower extremity injury, vestibular disorders
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 |
|---|---|---|
| Instrument-applied spinal manipulative therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 17 Oct 2008.
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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.
Kristan J. Giggey, DC principal investigator
Logan College of Chiropractic
Rodger Tepe, PhD study director
Logan College of Chiropractic
Questions about this trial
What is this clinical trial studying?
A study testing Instrument-applied spinal manipulative therapy in people with Heart Rate, run by Logan College of Chiropractic.
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 1 inclusion and 1 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 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 17 Oct 2008.