Improving womens health in pregnancy through biofeedback enabled core stabilizer for antenatal &post natal care : An interventional study

Not yet recruiting

Conditions: Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,

Registration Number: CTRI/2023/11/059518

Lead Sponsor: School of Physiotherapy, R K University

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 R****athod**

**KEYWORDS****:** Maternal Health, Biofeedback-Enabled Core Stabilizer, functional limitation, dysfunction of PFM

**BACKGROUND****:**Pregnancy, a cherished phase in a womanâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

1.Diastasis recti 2.Complete bed rest 3.Disc herniation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Strength parameter measurements facilitated by the Biofeedback-Enabled Core Stabilizer.	Before starting the intervention, end of the week for four weeks.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index,
Visual Analog Scale for pain	Before starting the intervention, end of the week for four weeks.

Trial Locations

Locations (1): School of Physiotherapy, R K University
🇮🇳
Rajkot, GUJARAT, India
School of Physiotherapy, R K University
🇮🇳Rajkot, GUJARAT, India
Dr Bhumika Chudasama
Principal investigator
7990519618
bchudasama743@rku.ac.in