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

This study is currently recruiting participants.
Verified by Cleveland Chiropractic College, July 2007

Sponsors and Collaborators: Cleveland Chiropractic College
Foundation for Chiropractic Education and Research
Information provided by: Cleveland Chiropractic College
ClinicalTrials.gov Identifier: NCT00497965
  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

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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 ]

Estimated Enrollment:   30
Study Start Date:   April 2007
Estimated Study Completion Date:   December 2008

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

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

Contacts
Contact: Emily Culver     816-501-0100     emily.culver@cleveland.edu    
Contact: Jennifer Bedard     816-501-0100     jennifer.bedard@cleveland.edu    

Locations
United States, Missouri
Cleveland Chiropractic College Health Center     Recruiting
      Kansas City, Missouri, United States, 64131
      Sub-Investigator: Mark T Pfefer, D.C., R.N.            
      Sub-Investigator: Richard Strunk, D.C.            
      Sub-Investigator: Michael Ramcharan, D.C.            
      Sub-Investigator: Nathan Uhl, D.C.            

Sponsors and Collaborators
Cleveland Chiropractic College
Foundation for Chiropractic Education and Research

Investigators
Principal Investigator:     Cheryl Hawk, D.C., Ph.D.     Cleveland Chiropractic College    
  More Information


Study ID Numbers:   IRB-07252006, FCER 06-10-02
First Received:   July 5, 2007
Last Updated:   July 5, 2007
ClinicalTrials.gov Identifier:   NCT00497965
Health Authority:   United States: Institutional Review Board

Keywords provided by Cleveland Chiropractic College:
Balance  
Chiropractic  
Older Adults  

ClinicalTrials.gov processed this record on October 06, 2008




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