Balance Control in ElderlyNCT01153412
Effect of Osteopathic Manipulation on Postural Stability in the Elderly
A study testing Osteopathic Manipulative Treatment in people with Balance Control in Elderly, run by University of North Texas Health Science Center.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Balance Control in Elderly
- What is being tested?
- Osteopathic Manipulative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years ofage and older
- Healthy
- Male and Female
Who cannot join
- Self report of a condition that could impair balance, such as otoneurologic, musculoskeletal or neurological diseases.
- Under the age of 65
About this study
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.
Read the 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.
- Conditions
- Balance Control in Elderly
- Being tested
- Osteopathic Manipulative Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
Osteopathic manipulation to determine balance and stability in elderly
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control group no intervention |
| Osteopathic Manipulative Treatment | Experimental | Osteopathic Manipulative medicine group Receives: Other: Osteopathic Manipulative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Center of Pressure
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startAug 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Balance Control in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Patterson, PhD, University of North Texas Health Science Center
- Investigators
- Rita Patterson, PhD, Principal investigator, UNTHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153412
- Sponsor's protocol ID
- 2008-087
- Status last verified
- Oct 2016
- First submitted
- 28 Jun 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Can provide de-identified center of pressure data from the project.
Publications
Lopez D, King HH, Knebl JA, Kosmopoulos V, Collins D, Patterson RM. Effects of comprehensive osteopathic manipulative treatment on balance in elderly patients: a pilot study. J Am Osteopath Assoc. 2011 Jun;111(6):382-8. doi: 10.7556/jaoa.2011.111.6.382.
PubMed 21771924
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathic Manipulation on Postural Stability in the Elderly
- ClinicalTrials.gov ID
- NCT01153412
- Acronym / sponsor ID
- 2008-087
- Conditions
- Balance Control in Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control group no intervention |
| Osteopathic Manipulative Treatment | Experimental | Other: Osteopathic Manipulative TreatmentOsteopathic Manipulative medicine group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years ofage and older
- Healthy
- Male and Female
Key exclusion criteria (2 listed)
- Self report of a condition that could impair balance, such as otoneurologic, musculoskeletal or neurological diseases.
- Under the age of 65
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentOsteopathic manipulation to determine balance and stability in elderly | Other | Osteopathic Manipulative Treatment |
Primary outcome
Balance
Time frame: 30 seconds
Center of Pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Results publication: PubMed 21771924Lopez D, King HH, Knebl JA, Kosmopoulos V, Collins D, Patterson RM. Effects of comprehensive osteopathic manipulative treatment on balance in elderly patients: a pilot study. J Am Osteopath Assoc. 2011 Jun;111(6):382-8. doi: 10.7556/jaoa.2011.111.6.382.
- Individual participant dataSharing planned: Yes. Can provide de-identified center of pressure data from the project.
Related trials for Balance Control in Elderly
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Chronic Pain, Musculoskeletal Pain
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Turkish Adaptation of the Multidimensional Falls Efficacy Scale in Older Adults
Balance Control in Elderly, Falls (Accidents) in Old Age
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Reactive Balance Training in Augmented Reality for Older Adults
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Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Patterson, PhD principal investigator
UNTHSC
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Balance Control in Elderly, run by University of North Texas Health Science Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01153412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.