Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03067116
Status:
COMPLETED
Last Update Posted:
2018-04-25
First Post:
2017-02-17
Brief Title:
Posturography Changes During Pregnancy
Sponsor:
Caps Research Network
Organization:
Caps Research Network
Study Overview
Official Title:
Posturography Changes During Pregnancy
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
1 Subjects will also be asked to answer a short health questionnaire
2 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
3 A session questionnaire will be used to determine if the subject had fallen or noticed any changes in their daily activity
4 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
5 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
6 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
1 Subjects will also be asked to answer a short health questionnaire
2 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
3 A session questionnaire will be used to determine if the subject had fallen or noticed any changes in their daily activity
4 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
5 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
6 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None