Clinical trial NCT00497965: Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults
Official title: Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Equilibrium
Keywords: Balance
Chiropractic
Older Adults
Lead sponsor: Cleveland Chiropractic College
Sponsor class: OTHER
Collaborators: name: Foundation for Chiropractic Education and Research (FCER)
First posted: 2007-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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.

Primary outcomes:
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.
timeFrame: Through December 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Cleveland Chiropractic College Health Center
state: Missouri
Study officials:
affiliation: Cleveland Chiropractic College
name: Cheryl Hawk, D.C., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: