- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03791047
Evaluation of Muscle Thickness and Balance in Young and Older Adults
March 10, 2019 updated by: Ozden Ozkal, Hacettepe University
The Relationship Between Muscle Thickness and Dynamic Balance in Young and Older Adults
This study evaluates muscle thickness of trunk and lower limb and balance in young and older healthy adults.
The participants will be evaluated muscle thickness for 14 different muscle and balance which evaluated by computerized force plate system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Aging had an adverse affect on musculoskeletal system and balance parameters.
Decreased muscle strength or thickness negatively affect person's balance control.
But there are no information in the literature about the relationships between muscle thickness and balance in healthy subjects.
In addition to, it is not known which muscle responsible for balance.
Therefore, this study will evaluate muscle thickness via ultrasonography and balance in young and older adults.
Balance will be evaluated computerized Balance system.
Muscle thickness for different 14 muscle ( diaphragm, transversus abdominis,multifidus, longissimus, quadratus lumborum, rectus abdominis, external and internal obliques, rectus femoris, vastus intermedius, vastus lateralis, tibialis anterior, gastrocnemius, soleus) will be evaluated by ultrasonography at the right side.
Only diaphram muscle will be evaluated both right and left side.
Study Type
Interventional
Enrollment (Actual)
136
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
-
-
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Ankara, Turkey, 06100
- Ozden Ozkal
-
-
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
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria For Young Adults:
- To be a volunteer to participate
- to be an aged 18-40 years old.
Inclusion Criteria For Older Adults:
- To be a volunteer to participate
- to be an aged 65-90 years old.
Exclusion Criteria:
- Walking with assist device
- Having a visual deficits
- Having an orthopedic problems that affect balance
- Having a neurological disorders
- Having a musculoskeletal disorders that affect balance
- Having an undergone orthopedic surgery
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: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group: Balance analysis
Sixty older subjects will be evaluated in this study.
Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively.
|
Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.
|
|
Active Comparator: Control Group:Balance Analysis
Sixty young subjects will be evaluated in this study.
Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively.
|
Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Limits of Stability
Time Frame: 15 minutes
|
Limits of stability test evaluates dynamic balance of participants.
Computerized balance system measured limits of stability for forward, backward, right and left side movements.
It calculates the maximum distance a person can lean without losing balance.
The unit of measure is centimeters.
The higher value is indicated the better balance.
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Sway
Time Frame: 15 minutes
|
Postural sway in centimeters by computerized balance system
|
15 minutes
|
|
Muscle thickness
Time Frame: 30 minutes
|
Muscle thickness in millimeters by Ultrasound
|
30 minutes
|
|
Fear of falling
Time Frame: 15 minutes
|
Fear of Falling will be evaluated by Fall Efficacy Scale - International is a questionnaire that assesses fear of falling.
The total scores range from 16 "absence of concern" to 64 "extreme concern.
|
15 minutes
|
|
Joint position sense
Time Frame: 15 minutes
|
Knee joint position sense test will be evaluated using an isokinetic dynamometer.
The testing included passive positioning performed by the assessor and active-repositioning performed by the participants.
As the difference between the target degree and the degree is increased, the sense of position worsens.
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ozden Ozkal, Hacettepe University
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.
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 (Actual)
January 5, 2019
Primary Completion (Actual)
February 15, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
December 29, 2018
First Submitted That Met QC Criteria
December 29, 2018
First Posted (Actual)
January 2, 2019
Study Record Updates
Last Update Posted (Actual)
March 12, 2019
Last Update Submitted That Met QC Criteria
March 10, 2019
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GO 18/506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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