Musculoskeletal EquilibriumNCT00497510
Feasibility Study of Short-Term Effects of Chiropractic Manipulation on Older Adults With Impaired Balance
A study testing Chiropractic manipulation in people with Musculoskeletal Equilibrium, run by Cleveland Chiropractic College at 2 sites in United States.
Trial summary
To study the effect of chiropractic care and a specific exercise program 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
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2006to Jul 2007
- 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 no more than 5 seconds (determined by averaging the time for both legs)
- Able to attend all scheduled sessions (by self-report.)
Who cannot join
- Non-ambulatory (that is, wheelchair bound); this precludes required balance testing; however, potential patients requiring assistive devices such as canes and walkers are not excluded.
- received chiropractic care, physical therapy or any other manual care procedure within the past three months (by self report)
- began an exercise program targeting balance and/or lower body strength within past month (by self report)
- contraindications to CMT or mild-exertion exercise, as determined by the clinician through physical exam and x-rays (if indicated). Contraindications included but are not limited to: unstable or severe medical condition; severe osteoporosis, fracture or other osseous abnormalities; "high cardiovascular risk", ie.e. persons with known cardiovascular, pulmonary or metabolic disease, or one or more major signs/symptoms suggestive of cardiovascular and pulmonary disease
- absence of indications for CMT, as determined by the clinician through history, physical exam, orthopedic tests, and static and motion palpation. Indications for CMT include identification of decreased or increased joint mobility usually accompanied by tenderness and muscle tension and spasm.
- unable to understand English or Spanish adequately to complete study forms and questionnaires, since for this study we do not have study personnel fluent in other languages.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Chiropractic College Health Center
Kansas City, Missouri, 64131
Cleveland Chiropractic College
Kansas City, Missouri, 64131
About this study
To study the effect of chiropractic care and a specific exercise program on balance in older adults.
Read the detailed description
Fall prevention in older adults is a significant public health issue that all health care providers must address. At this time, chiropractors, the most commonly used complementary and alternative medicine (CAM) practitioners, have not been systematically involved in either interventions for or research related to fall prevention and risk factor reduction. However, it is possible that body-based CAM practitioners such as chiropractors might make important contributions to decreasing fall risk through affecting musculoskeletal function and managing chronic pain, factors which may affect balance, an important risk factor for falls.
- Conditions
- Musculoskeletal Equilibrium
- Being tested
- Chiropractic manipulation
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Aim 1: Recruitment Tracking
Measured: through July 2007
Completeness of calendar collection, comparisons of baseline characteristics and assessments, qualitative assessment of utility of surveillance procedures.
Measured: Through July 2007
Documentation of Clinic Personnel Skills
Measured: Through July 2007
Statistical Analysis
Measured: Through July 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startOct 2006
- Study completionJul 2007
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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Chiropractic College
- Sponsor type
- University, hospital or other
- Investigators
- Cheryl Hawk, DC, PhD., Principal investigator, Cleveland Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497510
- Sponsor's protocol ID
- IRB-04052006
- Status last verified
- Jul 2007
- First submitted
- 5 Jul 2007
- Last updated
- 6 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Short-Term Effects of Chiropractic Manipulation on Older Adults With Impaired Balance
- ClinicalTrials.gov ID
- NCT00497510
- Acronym / sponsor ID
- IRB-04052006
- Conditions
- Musculoskeletal Equilibrium
- Keywords
- Balance, Chiropractic, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cleveland Chiropractic CollegeUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 6 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.
To study the effect of chiropractic care and a specific exercise program on balance in older adults.
Detailed description
Fall prevention in older adults is a significant public health issue that all health care providers must address. At this time, chiropractors, the most commonly used complementary and alternative medicine (CAM) practitioners, have not been systematically involved in either interventions for or research related to fall prevention and risk factor reduction. However, it is possible that body-based CAM practitioners such as chiropractors might make important contributions to decreasing fall risk through affecting musculoskeletal function and managing chronic pain, factors which may affect balance, an important risk factor for falls.
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 no more than 5 seconds (determined by averaging the time for both legs)
- Able to attend all scheduled sessions (by self-report.)
Key exclusion criteria (6 listed)
- Non-ambulatory (that is, wheelchair bound); this precludes required balance testing; however, potential patients requiring assistive devices such as canes and walkers are not excluded.
- received chiropractic care, physical therapy or any other manual care procedure within the past three months (by self report)
- began an exercise program targeting balance and/or lower body strength within past month (by self report)
- contraindications to CMT or mild-exertion exercise, as determined by the clinician through physical exam and x-rays (if indicated). Contraindications included but are not limited to: unstable or severe medical condition; severe osteoporosis, fracture or other osseous abnormalities; "high cardiovascular risk", ie.e. persons with known cardiovascular, pulmonary or metabolic disease, or one or more major signs/symptoms suggestive of cardiovascular and pulmonary disease
- absence of indications for CMT, as determined by the clinician through history, physical exam, orthopedic tests, and static and motion palpation. Indications for CMT include identification of decreased or increased 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 | – |
Primary outcome
Specific Aim 1: Recruitment Tracking
Time frame: through July 2007
Completeness of calendar collection, comparisons of baseline characteristics and assessments, qualitative assessment of utility of surveillance procedures.
Time frame: Through July 2007
Documentation of Clinic Personnel Skills
Time frame: Through July 2007
Statistical Analysis
Time frame: Through July 2007
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 6 Jul 2007.
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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, DC, PhD. principal investigator
Cleveland Chiropractic College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic manipulation in people with Musculoskeletal Equilibrium, run by Cleveland Chiropractic College at 2 sites 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 6 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 6 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Specific Aim 1: Recruitment Tracking (time frame: through July 2007). The study lists 4 primary outcomes in all. 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 6 Jul 2007.