Feasibility Study of Short-Term Effects of Chiropractic Manipulation on Older Adults With Impaired Balance

Musculoskeletal Equilibrium Clinical Trial

Official title:

Feasibility Study of Short-Term Effects of Chiropractic Manipulation on Older Adults With Impaired Balance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497510
• Other study ID #: IRB-04052006
• Status: Completed
• Phase: N/A
• First received: July 5, 2007
• Last updated: July 5, 2007
• Start date: October 2006
• Est. completion date: July 2007

Study information

• Verified date: July 2007
• Source: Cleveland Chiropractic College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To study the effect of chiropractic care and a specific exercise program on balance in older adults.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Aged 65 or older

2. Able to stand steadily without assistance on one leg for no more than 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 (that is, wheelchair bound); this precludes required balance testing; however, potential patients requiring assistive devices such as canes and walkers are not excluded.

2. received chiropractic care, physical therapy or any other manual care procedure within the past three months (by self report)

3. began an exercise program targeting balance and/or lower body strength within past month (by self report)

4. 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

5. 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.

6. 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Musculoskeletal Equilibrium

Intervention

Procedure:
• Chiropractic manipulation

Locations

Country	Name	City	State
United States	Cleveland Chiropractic College	Kansas City	Missouri
United States	Cleveland Chiropractic College Health Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Cleveland Chiropractic College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific Aim 1: Recruitment Tracking		through July 2007
Primary	Completeness of calendar collection, comparisons of baseline characteristics and assessments, qualitative assessment of utility of surveillance procedures.		Through July 2007
Primary	Documentation of Clinic Personnel Skills		Through July 2007
Primary	Statistical Analysis		Through July 2007