Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults

This study has been completed.
Sponsor:
Collaborator:
Foundation for Chiropractic Education and Research (FCER)
Information provided by:
Cleveland Chiropractic College
ClinicalTrials.gov Identifier:
NCT00497965
First received: July 5, 2007
Last updated: April 16, 2010
Last verified: April 2010

July 5, 2007
April 16, 2010
April 2007
December 2008   (final data collection date for 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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00497965 on ClinicalTrials.gov Archive Site
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Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Musculoskeletal Equilibrium
  • Procedure: Chiropractic Manipulation
  • Behavioral: Balance Exercises
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Aged 65 or older
  2. Able to stand steadily without assistance on one leg for an average of <5 seconds (determined by averaging the time for both legs)
  3. Able to attend all scheduled sessions (by self-report)

Exclusion Criteria:

  1. Non-ambulatory (wheelchair-bound); this precludes required balance testing; however, volunteers requiring assistive devices such as canes and walkers are not excluded
  2. received chiropractic care or other manual care within the past three months (by self-report)
  3. initiated exercise program for balance / lower body strength within the past month (by self-report)
  4. 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
  5. 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;
  6. unable to understand English adequately to complete study forms and questionnaires, because we do not have study personnel fluent in other languages;
  7. central causes of vertigo, including arteriovenous malformations, cerebral hemorrhage, brainstem vascular disease, tumors and demyelenating diseases.
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00497965
IRB-07252006, FCER 06-10-02
No
Dr. Cheryl Hawk, Cleveland Chiropractic College
Cleveland Chiropractic College
Foundation for Chiropractic Education and Research (FCER)
Principal Investigator: Cheryl Hawk, D.C., Ph.D. Cleveland Chiropractic College
Cleveland Chiropractic College
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP