- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00497510
Feasibility Study of Short-Term Effects of Chiropractic Manipulation on Older Adults With Impaired Balance
July 5, 2007 updated by: Cleveland Chiropractic College
To study the effect of chiropractic care and a specific exercise program on balance in older adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Fall prevention in older adults is a significant public health issue that all health care providers must address.
At this time, chiropractors, the most commonly used complementary and alternative medicine (CAM) practitioners, have not been systematically involved in either interventions for or research related to fall prevention and risk factor reduction.
However, it is possible that body-based CAM practitioners such as chiropractors might make important contributions to decreasing fall risk through affecting musculoskeletal function and managing chronic pain, factors which may affect balance, an important risk factor for falls.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64131
- Cleveland Chiropractic College
-
Kansas City, Missouri, United States, 64131
- Cleveland Chiropractic College Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 65 or older
- Able to stand steadily without assistance on one leg for no more than 5 seconds (determined by averaging the time for both legs)
- Able to attend all scheduled sessions (by self-report.)
Exclusion Criteria:
- Non-ambulatory (that is, wheelchair bound); this precludes required balance testing; however, potential patients requiring assistive devices such as canes and walkers are not excluded.
- received chiropractic care, physical therapy or any other manual care procedure within the past three months (by self report)
- began an exercise program targeting balance and/or lower body strength within past month (by self report)
- contraindications to CMT or mild-exertion exercise, as determined by the clinician through physical exam and x-rays (if indicated). Contraindications included but are not limited to: unstable or severe medical condition; severe osteoporosis, fracture or other osseous abnormalities; "high cardiovascular risk", ie.e. persons with known cardiovascular, pulmonary or metabolic disease, or one or more major signs/symptoms suggestive of cardiovascular and pulmonary disease
- absence of indications for CMT, as determined by the clinician through history, physical exam, orthopedic tests, and static and motion palpation. Indications for CMT include identification of decreased or increased joint mobility usually accompanied by tenderness and muscle tension and spasm.
- unable to understand English or Spanish adequately to complete study forms and questionnaires, since for this study we do not have study personnel fluent in other languages.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Specific Aim 1: Recruitment Tracking
Time Frame: through July 2007
|
through July 2007
|
|
Completeness of calendar collection, comparisons of baseline characteristics and assessments, qualitative assessment of utility of surveillance procedures.
Time Frame: Through July 2007
|
Through July 2007
|
|
Documentation of Clinic Personnel Skills
Time Frame: Through July 2007
|
Through July 2007
|
|
Statistical Analysis
Time Frame: Through July 2007
|
Through July 2007
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cheryl Hawk, DC, PhD., Cleveland Chiropractic College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
July 5, 2007
First Submitted That Met QC Criteria
July 5, 2007
First Posted (Estimate)
July 6, 2007
Study Record Updates
Last Update Posted (Estimate)
July 6, 2007
Last Update Submitted That Met QC Criteria
July 5, 2007
Last Verified
July 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-04052006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.