Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults
2 other identifiers
interventional
30
1 country
1
Brief Summary
The purpose is to study the effect of chiropractic care on balance in older adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 5, 2007
CompletedFirst Posted
Study publicly available on registry
July 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedApril 20, 2010
April 1, 2010
1.7 years
July 5, 2007
April 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Through December 2008
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Chiropractic College Health Center
Kansas City, Missouri, 64131, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl Hawk, D.C., Ph.D.
Cleveland Chiropractic College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 5, 2007
First Posted
July 9, 2007
Study Start
April 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
April 20, 2010
Record last verified: 2010-04