- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04173702
The Effect of Different Support Surfaces on Balance in Healthy Individuals
December 4, 2023 updated by: Melek Merve ERDEM, Recep Tayyip Erdogan University Training and Research Hospital
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
60
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
-
-
Altindag
-
Ankara, Altindag, Turkey, 06230
- Hacettepe University
-
-
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 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy individuals aged between 18-50
- Without any diagnosed disease
- Individuals who voluntarily agree to participate in this research
Exclusion Criteria:
- 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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Group
Postural sway and stability limits in assessment of healthy individuals
|
Computerized balance analysis system will use to evaluate postural sway and limits of stability at four different support surfaces.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Limits of Stability
Time Frame: 1 week
|
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.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Melek M. ERDEM, Tayyip Erdogan University Training and Research Hospital
- Study Chair: Ozden OZKAL, PT, PhD, Hacettepe University
- Study Chair: Ali I. Yalcin, PT, M.Sc., Hacettepe University
- Study Director: Semra TOPUZ, Assoc. Prof., 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 17, 2022
Primary Completion (Actual)
June 15, 2023
Study Completion (Actual)
October 16, 2023
Study Registration Dates
First Submitted
May 6, 2019
First Submitted That Met QC Criteria
November 19, 2019
First Posted (Actual)
November 22, 2019
Study Record Updates
Last Update Posted (Actual)
December 5, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- GO 19/86
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 6 months with completion of the result report.
IPD Sharing Access Criteria
Requestors will be required to sign a Data Access Agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
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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