DisequilibriumPhase 2NCT00521469
A Randomized Controlled Single-Blind Study of the Effects of Instrument-Applied Spinal Manipulative Therapy on Postural Control
A Phase 2 study testing Pro Adjuster in people with Disequilibrium, run by Logan College of Chiropractic at 1 site in United States.
Trial summary
To determine the effects of instrument-applied chiropractic manipulative therapy (CMT) on postural control. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Disequilibrium
- What is being tested?
- Pro Adjuster
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Mar 2008
- Phase
- Phase 2
- 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 60 years
- All sexes
- Adult
Who may be able to join
- Students, staff or faculty
Who cannot join
- No previous lower extremity injury, surgery, visual or vestibular condition that would affect balance
- Systemic illness that could have an adverse effect on balance
- Local infection, injury or other malignancy affecting the lower extremity
- any unstable joints of the lower extremity
- Any Spinal manipulation within 48 hours
- Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Logan College of Chiropractic
Chesterfield, Missouri, 63017
About this study
To determine the effects of instrument-applied chiropractic manipulative therapy (CMT) on postural control.
- Conditions
- Disequilibrium
- Being tested
- Pro Adjuster
- Keywords
- Disequilibrium, Spinal Manipulation, Postural control
- Medical subject headings
- Dysequilibrium syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro AdjusterDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisequilibriumStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Investigators
- Rodger Tepe, PhD, Principal investigator, Logan College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521469
- Sponsor's protocol ID
- RD0750805694
- Status last verified
- Aug 2007
- First submitted
- 24 Aug 2007
- 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
- A Randomized Controlled Single-Blind Study of the Effects of Instrument-Applied Spinal Manipulative Therapy on Postural Control
- ClinicalTrials.gov ID
- NCT00521469
- Acronym / sponsor ID
- RD0750805694
- Conditions
- Disequilibrium
- Keywords
- Disequilibrium, Spinal Manipulation, Postural control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 28 Aug 2007 (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.
To determine the effects of instrument-applied chiropractic manipulative therapy (CMT) on postural control.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Students, staff or faculty
Key exclusion criteria (7 listed)
- No previous lower extremity injury, surgery, visual or vestibular condition that would affect balance
- Systemic illness that could have an adverse effect on balance
- Local infection, injury or other malignancy affecting the lower extremity
- any unstable joints of the lower extremity
- Any Spinal manipulation within 48 hours
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 |
|---|---|---|
| Pro Adjuster | Device | – |
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.
Rodger Tepe, PhD principal investigator
Logan College of Chiropractic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pro Adjuster in people with Disequilibrium, run by Logan College of Chiropractic 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 1 inclusion and 7 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.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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.