BalancePhase 1/2NCT00470938
A Randomized Controlled Trial of the Effects of Reactive Neuromuscular Training on Balance
A Phase 1/2 study testing SpineForce Reactive Neuromuscular Trainer in people with Balance, run by Logan College of Chiropractic.
Trial summary
Falls are a major concern for the geriatric population and represent a significant public health problem. Various interventions are being explored to improve balance and decrease falls in the elderly. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- SpineForce Reactive Neuromuscular Trainer
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2007to Mar 2007
- Phase
- Phase 1/2
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young, healthy adults between the ages of 20 - 30, asymptomatic with respect to any balance specific disorder, and who are currently enrolled at Logan College.
Who cannot join
- A previous lower extremity injury;
- Previous lower extremity surgery;
- A visual or vestibular condition with accompanying balance difficulty;
- A diagnosis of Knee osteoarthritis;
- Currently receiving spinal manipulative therapy;
- Current participation in a regular exercise program;
- Use of any prescription medication, or herbal substance that may affect balance;
- Pregnancy
About this study
Falls are a major concern for the geriatric population and represent a significant public health problem. Various interventions are being explored to improve balance and decrease falls in the elderly. Success has been shown in some programs; various exercise interventions place emphasis on strength, balance, or endurance exercises. Results reported in the literature are still equivocal. Controversy exists as to optimal types of exercise, and the optimum frequency, duration, and intensity of exercise. It is believed that the SpineForce device, which places a unique combination of strength and balance demands upon the user, can result in rapid increases in balance as compared to other rehabilitation programs. Gains in balance have implications for geriatric populations as well as those seeking enhanced sports performance and injury prevention. The Purpose of this study is to assess the SpineForce device as a novel intervention in the treatment of balance disorders.
- Conditions
- Balance
- Being tested
- SpineForce Reactive Neuromuscular Trainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpineForce Reactive Neuromuscular TrainerDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Investigators
- Rodger Tepe, PhD, Study director, Logan College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470938
- Sponsor's protocol ID
- RD0202070062
- Status last verified
- Feb 2008
- First submitted
- 4 May 2007
- Last updated
- 29 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effects of Reactive Neuromuscular Training on Balance
- ClinicalTrials.gov ID
- NCT00470938
- Acronym / sponsor ID
- RD0202070062
- Conditions
- Balance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 8 May 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.
Falls are a major concern for the geriatric population and represent a significant public health problem. Various interventions are being explored to improve balance and decrease falls in the elderly. Success has been shown in some programs; various exercise interventions place emphasis on strength, balance, or endurance exercises. Results reported in the literature are still equivocal. Controversy exists as to optimal types of exercise, and the optimum frequency, duration, and intensity of exercise. It is believed that the SpineForce device, which places a unique combination of strength and balance demands upon the user, can result in rapid increases in balance as compared to other rehabilitation programs. Gains in balance have implications for geriatric populations as well as those seeking enhanced sports performance and injury prevention. The Purpose of this study is to assess the SpineForce device as a novel intervention in the treatment of balance disorders.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young, healthy adults between the ages of 20 - 30, asymptomatic with respect to any balance specific disorder, and who are currently enrolled at Logan College.
Key exclusion criteria (8 listed)
- A previous lower extremity injury;
- Previous lower extremity surgery;
- A visual or vestibular condition with accompanying balance difficulty;
- A diagnosis of Knee osteoarthritis;
- Currently receiving spinal manipulative therapy;
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 |
|---|---|---|
| SpineForce Reactive Neuromuscular Trainer | 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 29 Feb 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 study director
Logan College of Chiropractic
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SpineForce Reactive Neuromuscular Trainer in people with Balance, 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 8 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 29 Feb 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.
What does this combined 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.
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 29 Feb 2008.