HealthyNCT03791047
Evaluation of Muscle Thickness and Balance in Young and Older Adults
A study testing Balance Analysis in people with Healthy and Balance; Distorted, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Balance; Distorted
- What is being tested?
- Balance Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2019to 1 Mar 2019
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be a volunteer to participate
- to be an aged 18-40 years old.
- To be a volunteer to participate
- to be an aged 65-90 years old.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy, Balance; Distorted
- Being tested
- Balance Analysis
- Keywords
- Balance, Postural control, Muscle, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance AnalysisOther
Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Balance analysis | Experimental | Sixty older subjects will be evaluated in this study. Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively. Receives: Other: Balance Analysis |
| Control Group:Balance Analysis | Active comparator | Sixty young subjects will be evaluated in this study. Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively. Receives: Other: Balance Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limits of Stability
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.
Measured: 15 minutes
Secondary outcomes (4)
Muscle thickness
Muscle thickness in millimeters by Ultrasound
Measured: 30 minutes
Postural Sway
Postural sway in centimeters by computerized balance system
Measured: 15 minutes
Fear of falling
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.
Measured: 15 minutes
Joint position sense
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start5 Jan 2019
- Primary completion15 Feb 2019
- Study completion1 Mar 2019
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 HealthyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozden Ozkal, Hacettepe University
- Investigators
- Ozden Ozkal, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791047
- Sponsor's protocol ID
- GO 18/506
- Status last verified
- Dec 2018
- First submitted
- 29 Dec 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozkal O, Kara M, Topuz S, Kaymak B, Baki A, Ozcakar L. Assessment of core and lower limb muscles for static/dynamic balance in the older people: An ultrasonographic study. Age Ageing. 2019 Nov 1;48(6):881-887. doi: 10.1093/ageing/afz079.
PubMed 31268513
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Muscle Thickness and Dynamic Balance in Young and Older Adults
- ClinicalTrials.gov ID
- NCT03791047
- Acronym / sponsor ID
- GO 18/506
- Conditions
- Healthy, Balance; Distorted
- Keywords
- Balance, Postural control, Muscle, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 2 Jan 2019 (actual)
- 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.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Balance analysis | Experimental | Other: Balance AnalysisSixty older subjects will be evaluated in this study. Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively. |
| Control Group:Balance Analysis | Active comparator | Other: Balance AnalysisSixty young subjects will be evaluated in this study. Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be a volunteer to participate
- to be an aged 18-40 years old.
- To be a volunteer to participate
- to be an aged 65-90 years old.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Balance AnalysisBalance analysis is assessment method to estimate fall of risk and deterioration of postural control. | Other | Control Group:Balance Analysis, Experimental Group: Balance analysis |
Primary outcome
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.
4 secondary outcomes
Muscle thickness
Time frame: 30 minutes
Postural Sway
Time frame: 15 minutes
Fear of falling
Time frame: 15 minutes
Joint position sense
Time frame: 15 minutes
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 12 Mar 2019.
- Derived from this study: PubMed 31268513Ozkal O, Kara M, Topuz S, Kaymak B, Baki A, Ozcakar L. Assessment of core and lower limb muscles for static/dynamic balance in the older people: An ultrasonographic study. Age Ageing. 2019 Nov 1;48(6):881-887. doi: 10.1093/ageing/afz079.
- Individual participant dataSharing planned: No
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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.
Ozden Ozkal principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Analysis in people with Healthy and Balance; Distorted, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Limits of Stability (time frame: 15 minutes). 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 NCT03791047, 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 12 Mar 2019.