Pregnant WomenNCT03067116
Posturography Changes During Pregnancy
An observational study of Pregnant Women, run by Caps Research Network at 1 site in United States.
Trial summary
Determine balance changes during pregnancy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Posturography Evaluation, Anthropometrics and Vitals
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Apr 2018
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult, healthy pregnant women
Who may be able to join
- healthy women less than 20 weeks pregnant
Who cannot join
- women affected by any pathology and/or more than 20 weeks pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Innova Brain Rehabilitation
Marietta, Georgia, 30062
About this study
Determine balance changes during pregnancy
Read the detailed description
The subjects will be tested at enrollment and during weeks 20, 24, 28, 32, 36, 40 of their pregnancy, as well every 4 weeks postpartum up to 6 months. The following protocol will be used:
- Subjects will also be asked to answer a short health questionnaire.
- The following data will be recorded each time: height, minimum stance width, circumference measurements of the chest, abdomen, hip and each thigh as well as a supine fundal height. A full body side-profile photo was also taken to determine the curvature of the spine.
- A session questionnaire will be used to determine if the subject had fallen or noticed any changes in their daily activity.
- In a seated position, the following measurements will be recorded: 1-minute heart rate variability (HRV) with paced breathing, temporal scan body temperature, respiration rate, heart rate, blood pressure and SpO2 (these last three will be measured bilaterally).
- Subject will undergo posturography testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: four 30 s tests in the following conditions: eyes open on a rigid surface (NSEO), eyes closed on a rigid surface (NSEC), eyes open on a compliant surface (PSEO), and eyes closed on a compliant surface (PSEC).
- At the end of the posturography testing, heart rate, blood pressure and SpO2 will be re-measured bilaterally in the standing and then seated positions, as will be the seated HRV.
- Conditions
- Pregnant Women
- Being tested
- Posturography Evaluation, Anthropometrics, Vitals, Health and daily activity questionnaires
- Keywords
- balance, postural, fall risk, anthropometrics, blood pressure, SpO2, heart rate, heart rate variability, stance width
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posturography EvaluationDiagnostic test
Also called Balance Testing, CAPS® Testing
Posturography testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface in a comfortable posture, with eyes open or closed
AnthropometricsDiagnostic test
measurement of height, minimum stance width (feet together or as close as they can be), circumference of the torso at the breast level, of the abdomen, of the hip, and of each thigh, and supine fundal height
VitalsDiagnostic test
measurement (bilateral and seated/standing if applicable) of temperature, respiration rate, heart rate, blood pressure, pulse oxygenation and heart rate variability
Health and daily activity questionnairesOther
one time general health questionnaire as well as session questionnaires asking the subjects if they have fallen since their last testing session and how comfortable they are in doing daily activities
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Adult, healthy pregnant women undergoing Posturography Evaluation, Anthropometrics, Vitals and answering Health and daily activity questionnaires Receives: Diagnostic Test: Posturography Evaluation; Diagnostic Test: Anthropometrics; Diagnostic Test: Vitals; Other: Health and daily activity questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability Score
The Stability Score (calculated as percentage ratio of the actual sway and the theoretical limit of stability) will be used to investigate how balance changes during pregnancy and how it correlates to anthropometrics, vitals and questionnaires
Measured: From enrollment to 6 month post partum
Secondary outcomes (1)
Center of Pressure (CoP) coordinates
The CoP coordinates (standard posturography measurements) will be also used to investigate how balance changes during pregnancy and how it correlates to anthropometrics, vitals and questionnaires
Measured: From enrollment to 6 month post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startMay 2016
- Primary completionApr 2017
- Study completionApr 2018
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 Pregnant WomenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caps Research Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Oggero, PhD, Principal investigator, Caps Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067116
- Sponsor's protocol ID
- CI-IRB-20160524-01
- Status last verified
- Apr 2018
- First submitted
- 17 Feb 2017
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
C.C. Keiser, N.D. Keiser, G. Pagnacco, E. Oggero "REPEATED EVALUATIONS OF FALL RISK AND POSTUROGRAPHIC CHANGES DURING PREGNANCY AND POST-PARTUM: A FEASIBILITY STUDY", Biomedical Sciences Instrumentation, 2017, Vol. 53, pp 269-75.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posturography Changes During Pregnancy
- ClinicalTrials.gov ID
- NCT03067116
- Acronym / sponsor ID
- CI-IRB-20160524-01
- Conditions
- Pregnant Women
- Keywords
- balance, postural, fall risk, anthropometrics, blood pressure, SpO2, heart rate, heart rate variability, stance width
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Caps Research NetworkUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 1 Mar 2017 (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.
Determine balance changes during pregnancy
Detailed description
The subjects will be tested at enrollment and during weeks 20, 24, 28, 32, 36, 40 of their pregnancy, as well every 4 weeks postpartum up to 6 months. The following protocol will be used:
- Subjects will also be asked to answer a short health questionnaire.
- The following data will be recorded each time: height, minimum stance width, circumference measurements of the chest, abdomen, hip and each thigh as well as a supine fundal height. A full body side-profile photo was also taken to determine the curvature of the spine.
- A session questionnaire will be used to determine if the subject had fallen or noticed any changes in their daily activity.
- In a seated position, the following measurements will be recorded: 1-minute heart rate variability (HRV) with paced breathing, temporal scan body temperature, respiration rate, heart rate, blood pressure and SpO2 (these last three will be measured bilaterally).
- Subject will undergo posturography testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: four 30 s tests in the following conditions: eyes open on a rigid surface (NSEO), eyes closed on a rigid surface (NSEC), eyes open on a compliant surface (PSEO), and eyes closed on a compliant surface (PSEC).
- At the end of the posturography testing, heart rate, blood pressure and SpO2 will be re-measured bilaterally in the standing and then seated positions, as will be the seated HRV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Diagnostic Test: Posturography Evaluation, Diagnostic Test: Anthropometrics, Diagnostic Test: Vitals, Other: Health and daily activity questionnairesAdult, healthy pregnant women undergoing Posturography Evaluation, Anthropometrics, Vitals and answering Health and daily activity questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, healthy pregnant women
Key inclusion criteria (1 listed)
- healthy women less than 20 weeks pregnant
Key exclusion criteria (1 listed)
- women affected by any pathology and/or more than 20 weeks pregnant
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 |
|---|---|---|
| Posturography EvaluationAlso: Balance Testing, CAPS® TestingPosturography testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface in a comfortable posture, with eyes open or closed | Diagnostic test | Subjects |
| Anthropometricsmeasurement of height, minimum stance width (feet together or as close as they can be), circumference of the torso at the breast level, of the abdomen, of the hip, and of each thigh, and supine fundal height | Diagnostic test | Subjects |
| Vitalsmeasurement (bilateral and seated/standing if applicable) of temperature, respiration rate, heart rate, blood pressure, pulse oxygenation and heart rate variability | Diagnostic test | Subjects |
| Health and daily activity questionnairesone time general health questionnaire as well as session questionnaires asking the subjects if they have fallen since their last testing session and how comfortable they are in doing daily activities | Other | Subjects |
Primary outcome
Stability Score
Time frame: From enrollment to 6 month post partum
The Stability Score (calculated as percentage ratio of the actual sway and the theoretical limit of stability) will be used to investigate how balance changes during pregnancy and how it correlates to anthropometrics, vitals and questionnaires
1 secondary outcome
Center of Pressure (CoP) coordinates
Time frame: From enrollment to 6 month post partum
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 23 Oct 2026.
- Results publicationC.C. Keiser, N.D. Keiser, G. Pagnacco, E. Oggero "REPEATED EVALUATIONS OF FALL RISK AND POSTUROGRAPHIC CHANGES DURING PREGNANCY AND POST-PARTUM: A FEASIBILITY STUDY", Biomedical Sciences Instrumentation, 2017, Vol. 53, pp 269-75.
- 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.
Elena Oggero, PhD principal investigator
Caps Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women, run by Caps Research Network at 1 site in United States.
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 1 inclusion and 1 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 23 Oct 2026. 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 United States. 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?
Stability Score (time frame: From enrollment to 6 month post partum). 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 NCT03067116, 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 23 Oct 2026.