NCT00497965

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 20, 2010

Status Verified

April 1, 2010

Enrollment Period

1.7 years

First QC Date

July 5, 2007

Last Update Submit

April 16, 2010

Conditions

Keywords

BalanceChiropracticOlder Adults

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Non-ambulatory (wheelchair-bound); this precludes required balance testing; however, volunteers requiring assistive devices such as canes and walkers are not excluded
  • received chiropractic care or other manual care within the past three months (by self-report)
  • initiated exercise program for balance / lower body strength within the past month (by self-report)
  • 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
  • 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;
  • unable to understand English adequately to complete study forms and questionnaires, because we do not have study personnel fluent in other languages;
  • central causes of vertigo, including arteriovenous malformations, cerebral hemorrhage, brainstem vascular disease, tumors and demyelenating diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Chiropractic College Health Center

Kansas City, Missouri, 64131, United States

Location

MeSH Terms

Interventions

Manipulation, Chiropractic

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeutics

Study Officials

  • Cheryl Hawk, D.C., Ph.D.

    Cleveland Chiropractic College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 9, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 20, 2010

Record last verified: 2010-04

Locations