Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults
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ClinicalTrials.gov Identifier: NCT00497965 |
Recruitment Status
:
Completed
First Posted
: July 9, 2007
Last Update Posted
: April 20, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Musculoskeletal Equilibrium | Procedure: Chiropractic Manipulation Behavioral: Balance Exercises | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Prevention |
Official Title: | Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults? |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

- 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 ]

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Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497965
United States, Missouri | |
Cleveland Chiropractic College Health Center | |
Kansas City, Missouri, United States, 64131 |
Principal Investigator: | Cheryl Hawk, D.C., Ph.D. | Cleveland Chiropractic College |
Responsible Party: | Dr. Cheryl Hawk, Cleveland Chiropractic College |
ClinicalTrials.gov Identifier: | NCT00497965 History of Changes |
Other Study ID Numbers: |
IRB-07252006 FCER 06-10-02 |
First Posted: | July 9, 2007 Key Record Dates |
Last Update Posted: | April 20, 2010 |
Last Verified: | April 2010 |
Keywords provided by Cleveland Chiropractic College:
Balance Chiropractic Older Adults |