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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Equilibrium
• Intervention / Treatment: Procedure: Chiropractic Manipulation; Behavioral: Balance Exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Cleveland Chiropractic College Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Cleveland Chiropractic College
• Collaborators: Foundation for Chiropractic Education and Research (FCER)
• Investigators: Principal Investigator: Cheryl Hawk, D.C., Ph.D., Cleveland Chiropractic College

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: July 5, 2007
• First Submitted That Met QC Criteria: July 5, 2007
• First Posted (Estimate): July 9, 2007

Study Record Updates

• Last Update Posted (Estimate): April 20, 2010
• Last Update Submitted That Met QC Criteria: April 16, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Balance; Older Adults; Chiropractic
• Other Study ID Numbers: IRB-07252006; FCER 06-10-02