Effect of Osteopathic Manipulation on Postural Stability in the Elderly

October 31, 2016 updated by: Rita Patterson, PhD, University of North Texas Health Science Center
Postural stability and balance are defined as the body's ability to return the body back to its equilibrium point when exposed to a perturbation. This exploratory project is based on the hypotheses that decreased balance (increased sway as measured by the center of pressure of the body during quiet standing) causes an increased risk of falls and osteopathic manipulative treatment can improve postural balance. To test these hypotheses, the investigators will investigate the kinematics (study of the way the body moves) of postural balance in two cohorts of healthy elders, those receiving manipulation and those not receiving manipulation. We hypothesize that OMT is effective to increase postural stability, balance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postural stability and balance are defined as the body's ability to return the body back to its equilibrium point when exposed to a perturbation. This exploratory project is based on the hypotheses that decreased balance(increased sway as measured by the center of pressure of the body during quiet standing) causes an increased risk of falls and osteopathic manipulative treatment can improve postural balance. To test these ideas, the investigators will investigate the kinematics(study of the way the body moves)of postural balance in two cohorts of healthy elders, those receiving manipulation and those not receiving manipulation. We hypothesize that OMT is effective to increase postural stability, balance.

Specific Aims Aim 1: To measure balance in a cohort of healthy elders(age 65 and over)using a force plate to measure center of pressure in the Anterior/posterior and medial-lateral directions during quiet standing with the eyes open, with the eyes closed and during a Romberg test.

Aim 2: To evaluate the effectiveness of OMT to improve balance in a healthy elderly population. We will observe the progression of improvement in balance in one group who will receive OMT for four weeks compared to the other who will not receive OMT.

Aim 3: To examine any potential impact and efficacy of OMT on cardiac and circulatory responses by measuring blood flow and circulation.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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:

  • 65 years ofage and older
  • Healthy
  • Male and Female

Exclusion Criteria:

  • Self report of a condition that could impair balance, such as otoneurologic, musculoskeletal or neurological diseases.
  • Under the age of 65

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Control group no intervention
Experimental: Osteopathic Manipulative Treatment
Osteopathic Manipulative medicine group
Other: Osteopathic Manipulative Treatment
Osteopathic manipulation to determine balance and stability in elderly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: 30 seconds
Center of Pressure
30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Texas Health Science Center

Investigators

  • Principal Investigator: Rita Patterson, PhD, UNTHSC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 29, 2010

First Posted (Estimate)

June 30, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2008-087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Can provide de-identified center of pressure data from the project.

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.

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