Musculoskeletal EquilibriumNCT00497965
Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults
A study testing Chiropractic Manipulation and Balance Exercises in people with Musculoskeletal Equilibrium, run by Cleveland Chiropractic College at 1 site in United States.
Trial summary
The purpose is to study the effect of chiropractic care on balance in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Equilibrium
- What is being tested?
- Chiropractic Manipulation and Balance Exercises
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Dec 2008
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 or older
- Able to stand steadily without assistance on one leg for an average of <5 seconds (determined by averaging the time for both legs)
- Able to attend all scheduled sessions (by self-report)
Who cannot join
- Non-ambulatory (wheelchair-bound); this precludes required balance testing; however, volunteers requiring assistive devices such as canes and walkers are not excluded
- received chiropractic care or other manual care within the past three months (by self-report)
- initiated exercise program for balance / lower body strength within the past month (by self-report)
- contraindications to SMT or mild-exertion exercise, as determined by the clinician through physical exam and x-rays (if indicated). Contraindications include but are not limited to: signs and symptoms associated with vertebrobasilar insufficiency (including facial numbness, diplopia, drop attacks, dysphagia, and ataxia which are not fatiguable or habituable with repeated provocative head positioning); unstable or severe medical condition; severe osteoporosis, fracture or other osseous abnormalities; "high cardiovascular risk", i.e. persons with known severe cardiovascular, pulmonary or metabolic disease, or one or more major signs/symptoms suggestive of cardiovascular and pulmonary disease
- absence of indications for SMT, as determined by the clinician through history, physical exam, orthopedic tests, and static and motion palpation. Indications for SMT include identification of decreased or increased spinal joint mobility usually accompanied by tenderness and muscle tension and spasm;
- unable to understand English adequately to complete study forms and questionnaires, because we do not have study personnel fluent in other languages;
- central causes of vertigo, including arteriovenous malformations, cerebral hemorrhage, brainstem vascular disease, tumors and demyelenating diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Chiropractic College Health Center
Kansas City, Missouri, 64131
About this study
Official title: Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults?
The purpose is to study the effect of chiropractic care on balance in older adults.
Read the detailed description
The specific aims of this pilot study are to: 1) build a recruitment pool of older adults within the local community; 2) establish a protocol for long-term surveillance of falls for older adult chiropractic patients; 3) explore dose-response patterns to chiropractic care by comparing Berg Balance Scale scores at 12 months from baseline in three groups of older adults with impaired balance.
- Conditions
- Musculoskeletal Equilibrium
- Being tested
- Chiropractic Manipulation, Balance Exercises
- Keywords
- Balance, Chiropractic, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic ManipulationProcedure or surgery
Balance ExercisesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change scores for the BBS from baseline to 8 weeks will be compared with a one-factor analysis of variance. Post-hoc comparisons of means and associated confidence intervals will be evaluated using the Tukey test.
Measured: Through December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal EquilibriumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleveland Chiropractic College
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Chiropractic Education and Research (FCER)
- Investigators
- Cheryl Hawk, D.C., Ph.D., Principal investigator, Cleveland Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497965
- Sponsor's protocol ID
- IRB-07252006
- Other IDs
- FCER 06-10-02
- Status last verified
- Apr 2010
- First submitted
- 5 Jul 2007
- Last updated
- 20 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults?
- ClinicalTrials.gov ID
- NCT00497965
- Acronym / sponsor ID
- IRB-07252006
- Conditions
- Musculoskeletal Equilibrium
- Keywords
- Balance, Chiropractic, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cleveland Chiropractic CollegeUniversity, hospital or other
- Collaborators
- Foundation for Chiropractic Education and Research (FCER)
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Jul 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.
The purpose is to study the effect of chiropractic care on balance in older adults.
Detailed description
The specific aims of this pilot study are to: 1) build a recruitment pool of older adults within the local community; 2) establish a protocol for long-term surveillance of falls for older adult chiropractic patients; 3) explore dose-response patterns to chiropractic care by comparing Berg Balance Scale scores at 12 months from baseline in three groups of older adults with impaired balance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 or older
- Able to stand steadily without assistance on one leg for an average of <5 seconds (determined by averaging the time for both legs)
- Able to attend all scheduled sessions (by self-report)
Key exclusion criteria (7 listed)
- Non-ambulatory (wheelchair-bound); this precludes required balance testing; however, volunteers requiring assistive devices such as canes and walkers are not excluded
- received chiropractic care or other manual care within the past three months (by self-report)
- initiated exercise program for balance / lower body strength within the past month (by self-report)
- contraindications to SMT or mild-exertion exercise, as determined by the clinician through physical exam and x-rays (if indicated). Contraindications include but are not limited to: signs and symptoms associated with vertebrobasilar insufficiency (including facial numbness, diplopia, drop attacks, dysphagia, and ataxia which are not fatiguable or habituable with repeated provocative head positioning); unstable or severe medical condition; severe osteoporosis, fracture or other osseous abnormalities; "high cardiovascular risk", i.e. persons with known severe cardiovascular, pulmonary or metabolic disease, or one or more major signs/symptoms suggestive of cardiovascular and pulmonary disease
- absence of indications for SMT, as determined by the clinician through history, physical exam, orthopedic tests, and static and motion palpation. Indications for SMT include identification of decreased or increased spinal joint mobility usually accompanied by tenderness and muscle tension and spasm;
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 Manipulation | Procedure or surgery | – |
| Balance Exercises | Behavioural | – |
Primary outcome
Mean change scores for the BBS from baseline to 8 weeks will be compared with a one-factor analysis of variance. Post-hoc comparisons of means and associated confidence intervals will be evaluated using the Tukey test.
Time frame: Through December 2008
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 20 Apr 2010.
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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.
Cheryl Hawk, D.C., Ph.D. principal investigator
Cleveland Chiropractic College
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 Manipulation and Balance Exercises in people with Musculoskeletal Equilibrium, run by Cleveland Chiropractic College 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 3 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 20 Apr 2010. 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.
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?
Mean change scores for the BBS from baseline to 8 weeks will be compared with a one-factor analysis of variance. Post-hoc comparisons of means and associated confidence intervals will be evaluated using the Tukey test. (time frame: Through December 2008). 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 20 Apr 2010.