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
  Purpose

The purpose is to study the effect of chiropractic care on balance in older adults.


Condition Intervention
Musculoskeletal Equilibrium
Procedure: Chiropractic Manipulation
Behavioral: Balance Exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults?

Further study details as provided by Cleveland Chiropractic College:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497965

Locations
United States, Missouri
Cleveland Chiropractic College Health Center
Kansas City, Missouri, United States, 64131
Sponsors and Collaborators
Cleveland Chiropractic College
Foundation for Chiropractic Education and Research (FCER)
Investigators
Principal Investigator: Cheryl Hawk, D.C., Ph.D. Cleveland Chiropractic College
  More Information

No publications provided

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
Study First Received: July 5, 2007
Last Updated: April 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Cleveland Chiropractic College:
Balance
Chiropractic
Older Adults

ClinicalTrials.gov processed this record on September 29, 2014