HealthyNCT04173702
The Effect of Different Support Surfaces on Balance in Healthy Individuals
A study testing balance analysis in people with Healthy, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will evaluate how age, visual sensation and different ground properties affect of postural sways and stability limits at different support surface widths. 60 individuals will be included in this study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- balance analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2022to 16 Oct 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals aged between 18-50
- Without any diagnosed disease
- Individuals who voluntarily agree to participate in this research
Who cannot join
- The presence of previous lower extremity surgery
- Pain during evaluation
- Foot ankle instability
- Important and irreversible visual deficits
- Body mass index (BMI) greater than> 40 kg / m²
- Limitation of ankle, knee and hip joint in lower extremity
- Muscle strength of the lower extremity (dorsiflexors, plantar flexors, quadriceps, hamstring, gluteus maximus, gluteus medius) and the trunk (rectus abdominous, internal and external oblique abdominals, back extensor) below 5.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Support Surface on Postural Sway and Limits of Stability in Healthy Individuals
This study will evaluate how age, visual sensation and different ground properties affect of postural sways and stability limits at different support surface widths. 60 individuals will be included in this study.
Read the detailed description
Balance is considered to be an important component of performance during activity as a result of a complex process in which musculoskeletal and neurological systems function. Two different balance states are defined as the static balance where the individuals maintain their inactive position or the dynamic balance when they perform a foreseen movement. The balance is maintained by keeping the center of gravity within the boundaries of the support surface and is provided by sensory impulses from the visual, vestibular and somatosensory systems organized by the central nervous system. Balance is an important factor to lead an independent life, and it is imperative that the balance be ensured in order to ensure that daily living activities are performed safely. The neural control of the bipedal posture varies depending on the width of the supporting surface, which has a significant impact on the frontal plane biomechanics. There is a linear relationship between increased support surface size and mechanical stability. In experimental studies, it has been shown that increasing muscle width levels in response to translational perturbations seen on the support surface on the horizontal plane have decreased with increasing step width. The changes in the preferred support surface vary depending on the age of the external environment, recurrent falls due to decreased sensory input, or various neurological disorders. However, there are few quantitative studies examining the relationship between different support surface widths and equilibrium, and the effect of posture width on sensory feedback control is still poorly understood. This study was planned to evaluate the effect of age, visual sensation and different soil properties on postural release and stability limits at different support surface widths.
- Conditions
- Healthy
- Being tested
- balance analysis
- Keywords
- Balance, Stance width, Postural sway, Limits of stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance analysisDiagnostic test
Computerized balance analysis system will use to evaluate postural sway and limits of stability at four different support surfaces.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Group | Experimental | Postural sway and stability limits in assessment of healthy individuals Receives: Diagnostic Test: balance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Sway
Postural sways were used to evaluate dynamic balance. Postural sway, in terms of human sense of balance, refers to horizontal movement around the center of gravity. Postural sway was assessed during quite standing with open/closed eyes on a hard/soft floor with the Bertec Balance System on 4 different support surfaces: adjacent feet, width of the bitrochanteric diameter, increased by 50% width of the bitrochanteric diameter and reduced by 50% of the width of the bitrochanteric diameter randomly.
Measured: 1 week
Secondary outcomes (1)
The Limits of Stability
The limits of stability were used to evaluate static balance. Limits of stability is the greatest distance in any direction a person can lean away from a midline vertical position without falling, stepping, or reaching for support. Participants were assessed with a force platform (Model BP 5050; Bertec Corporation, Columbus, Ohio) in terms of support surfaces on limits of stability (LoS) in the right, left, front and back directions when the eyes were open on the hard floor with the Bertec Balance System on 4 different support surfaces: adjacent feet, width of the bitrochanteric diameter, increased by 50% width of the bitrochanteric diameter and reduced by 50% of the width of the bitrochanteric diameter randomly.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start17 Jan 2022
- Primary completion15 Jun 2023
- Study completion16 Oct 2023
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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trials with a single arm
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Melek Merve ERDEM, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Melek M. ERDEM, Principal investigator, Tayyip Erdogan University Training and Research HospitalSemra TOPUZ, Assoc. Prof., Study director, Hacettepe UniversityOzden OZKAL, PT, PhD, Study chair, Hacettepe UniversityAli I. Yalcin, PT, M.Sc., Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173702
- Sponsor's protocol ID
- GO 19/86
- Status last verified
- Dec 2023
- First submitted
- 6 May 2019
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Goodworth AD, Mellodge P, Peterka RJ. Stance width changes how sensory feedback is used for multisegmental balance control. J Neurophysiol. 2014 Aug 1;112(3):525-42. doi: 10.1152/jn.00490.2013. Epub 2014 Apr 23.
PubMed 24760788
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Support Surface on Postural Sway and Limits of Stability in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04173702
- Acronym / sponsor ID
- GO 19/86
- Conditions
- Healthy
- Keywords
- Balance, Stance width, Postural sway, Limits of stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 22 Nov 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 will evaluate how age, visual sensation and different ground properties affect of postural sways and stability limits at different support surface widths. 60 individuals will be included in this study.
Detailed description
Balance is considered to be an important component of performance during activity as a result of a complex process in which musculoskeletal and neurological systems function. Two different balance states are defined as the static balance where the individuals maintain their inactive position or the dynamic balance when they perform a foreseen movement. The balance is maintained by keeping the center of gravity within the boundaries of the support surface and is provided by sensory impulses from the visual, vestibular and somatosensory systems organized by the central nervous system. Balance is an important factor to lead an independent life, and it is imperative that the balance be ensured in order to ensure that daily living activities are performed safely. The neural control of the bipedal posture varies depending on the width of the supporting surface, which has a significant impact on the frontal plane biomechanics. There is a linear relationship between increased support surface size and mechanical stability. In experimental studies, it has been shown that increasing muscle width levels in response to translational perturbations seen on the support surface on the horizontal plane have decreased with increasing step width. The changes in the preferred support surface vary depending on the age of the external environment, recurrent falls due to decreased sensory input, or various neurological disorders. However, there are few quantitative studies examining the relationship between different support surface widths and equilibrium, and the effect of posture width on sensory feedback control is still poorly understood. This study was planned to evaluate the effect of age, visual sensation and different soil properties on postural release and stability limits at different support surface widths.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trials with a single arm
| Arm | Type | Receives |
|---|---|---|
| Healthy Group | Experimental | Diagnostic Test: balance analysisPostural sway and stability limits in assessment of healthy individuals |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy individuals aged between 18-50
- Without any diagnosed disease
- Individuals who voluntarily agree to participate in this research
Key exclusion criteria (7 listed)
- The presence of previous lower extremity surgery
- Pain during evaluation
- Foot ankle instability
- Important and irreversible visual deficits
- Body mass index (BMI) greater than> 40 kg / m²
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 analysisComputerized balance analysis system will use to evaluate postural sway and limits of stability at four different support surfaces. | Diagnostic test | Healthy Group |
Primary outcome
Postural Sway
Time frame: 1 week
Postural sways were used to evaluate dynamic balance. Postural sway, in terms of human sense of balance, refers to horizontal movement around the center of gravity. Postural sway was assessed during quite standing with open/closed eyes on a hard/soft floor with the Bertec Balance System on 4 different support surfaces: adjacent feet, width of the bitrochanteric diameter, increased by 50% width of the bitrochanteric diameter and reduced by 50% of the width of the bitrochanteric diameter randomly.
1 secondary outcome
The Limits of Stability
Time frame: 1 week
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 5 Dec 2023.
- Background: PubMed 24760788Goodworth AD, Mellodge P, Peterka RJ. Stance width changes how sensory feedback is used for multisegmental balance control. J Neurophysiol. 2014 Aug 1;112(3):525-42. doi: 10.1152/jn.00490.2013. Epub 2014 Apr 23.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Melek M. ERDEM principal investigator
Tayyip Erdogan University Training and Research Hospital
Semra TOPUZ, Assoc. Prof. study director
Hacettepe University
Ozden OZKAL, PT, PhD study chair
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, run by Recep Tayyip Erdogan University Training and Research Hospital 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 3 inclusion and 7 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 5 Dec 2023. 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?
Postural Sway (time frame: 1 week). 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 NCT04173702, 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 5 Dec 2023.