| CTRI Number |
CTRI/2023/11/059518 [Registered on: 03/11/2023] Trial Registered Prospectively |
| Last Modified On: |
02/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving womens health in pregnancy through biofeedback enabled core stabilizer for antenatal &
post natal care : An interventional study |
|
Scientific Title of Study
|
Empowering womens through pregnancy :Introducing Biofeedback enabled core stabilizer for antenatal and postnatal care |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhumika Chudasama |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, R K University |
| Address |
School of Physiotherapy, R K University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
7990519618 |
| Fax |
|
| Email |
bchudasama743@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Priyanshu V Rathod PT PhD |
| Designation |
PT, PhD, Director, IQAC, Dean, Faculty of Medicine, RK University. |
| Affiliation |
School of Physiotherapy, R K University |
| Address |
School of Physiotherapy,
R K University,
Kasturbadham,
Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9426803108 |
| Fax |
|
| Email |
priyanshu.rathod@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Priyanshu V Rathod PT PhD |
| Designation |
PT, PhD, Director, IQAC, Dean, Faculty of Medicine, RK University. |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
School of Physiotherapy, R K University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9426803108 |
| Fax |
|
| Email |
priyanshu.rathod@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, R K University , Kasturbadham , Rajkot-Bhavnagar highway, Rajkot, Gujrat, India |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy, R K University |
| Address |
School of Physiotherapy, R K University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhumika Chudasama |
School of Physiotherapy, R K University |
Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India
Rajkot
GUJARAT |
7990519618
bchudasama743@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, School of Physiotherapy, R K University. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biofeedback enabled core stabilizer |
For experimental group exercises will be given by this device and check pre and post outcome measures. This is 15 sessions intervention plan . |
| Comparator Agent |
Static back exercises |
For control group give static back exercises manually and check pre and post outcome measures. this is 15 sessions intervention plan . |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. AGE -20 - 35 years,
2. Prenatal and postnatal period.
3. Recommended bed rest due to either Non-specific mechanical LBP with the following possible reasons where the applicability of biofeedback-Enabled Core Stabilizer is advisable. e.g. Pre-eclampsia, vaginal bleeding, Premature labour, Incompetent cervix, Expecting multiples, or previous pregnancy complications.
4. Postpartum phase till 2 months considering the Cesarean sections and Vaginal delivery. |
|
| ExclusionCriteria |
| Details |
1.Diastasis recti
2.Complete bed rest
3.Disc herniation |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Strength parameter measurements facilitated by the Biofeedback-Enabled Core Stabilizer. |
Before starting the intervention, end of the week for four weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oswestry Disability Index,
|
Before starting the intervention ,end of the intervention |
| Visual Analog Scale for pain |
Before starting the intervention, end of the week for four weeks. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Empowering Women through Pregnancy: Introducing the Biofeedback-Enabled Core Stabilizer for Antenatal and Postnatal Care. Submitted By : Bhumika Chudasama Guided By : (Prof) Dr. Priyanshu Rathod KEYWORDS: Maternal Health, Biofeedback-Enabled Core Stabilizer, functional limitation, dysfunction of PFM BACKGROUND: Pregnancy, a cherished phase in a woman’s life, brings about numerous physical, functional, and mental changes. However, it can also lead to undesirable physical limitations, such as muscle weakness and low back pain, potentially leading to bedridden situations during both antenatal and postnatal stages. Recognizing this cycle, the innovative Biofeedback-Enabled Core Stabilizer offers a comprehensive solution. Specifically designed for bedridden pregnant women, this device enables the maintenance of lower back and pelvic floor muscle strength with minimal movement in the supine position. By reducing pain and promoting preparedness for normal delivery, it facilitates early recovery during the postnatal phase, ensuring a smoother and healthier pregnancy journey. OBJECTIVES : 1. Assessing the Effectiveness of the Biofeedback-Enabled Core Stabilizer in Reducing Low Back Pain during Pregnancy. 2. Evaluating the Impact of the Biofeedback-Enabled Core Stabilizer on Muscle Strength for the Lower Back and Pelvic Floor during Antenatal and Postnatal Phases. 3. The Effectiveness of the Biofeedback-Enabled Core Stabilizer in Enhancing Functional Mobility among Pregnant Women. HYPOTHESIS : Null hypothesis : There is no significant effect of biofeedback-enabled core stabilizer in Antenatal periods. There is no significant effect of biofeedback-enabled core stabilizer in postnatal periods. Alternative hypothesis : There is a significant effect of biofeedback-enabled core stabilizer in prenatal periods. There is a significant effect of biofeedback-enabled core stabilizer in postnatal periods.
METHODOLOGY: Ethical approval will be obtained from the CDSCO-approved Ethical Committee, and written informed consent will be obtained from women in the prenatal and postnatal stages based on inclusive and exclusive criteria. The single-phase study will include 30 subjects in the control and experimental groups to observe changes over a 4-week intervention period. The control group receives back exercises as per the conventional therapy, however, the experimental group will have conventional therapy with biofeedback enabling core stabiliser device. Pre and post-assessments will involve the use of the VAS scale, Oswestry Disability Index, Scale, and strength parameter measurements using the biofeedback-enabled Core Stabilizer for further statistical analysis. STATISTICAL ANALYSIS: The data will be analyzed using SPSS version 21. A confidence interval of 95% and a level of significance of 0.05 will be set. Before data analysis, a test of normality will be conducted. Pre and post-changes in muscle strength, VAS for Pain and functional disability scale within and between the groups will be taken for result analysis discussion and conclusion. |