| CTRI Number |
CTRI/2025/08/093708 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Birthing Ball Exercises on Maternal and Neonatal Outcomes |
|
Scientific Title of Study
|
Effect of birthing ball exercises versus conventional physiotherapy on maternal and neonatal outcomes in healthy antenatal mothers A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ketki Kunjarkar |
| Designation |
Post Graduate |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
OPD no 404, Department of Community Physiotherapy,Dr.A.P.J.Abdul Kalam College of Physiotherapy
Loni Bk-413736, Tal:Rahata, Dist- Ahmednagar
Maharashtra State, India.
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8975159157 |
| Fax |
|
| Email |
ketkikunjarkar05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Hande |
| Designation |
HOD & Professor |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
OPD no 404,Deaprtment of CommunityPhysiotherapy,Dr.A.P.J.Abdul Kalam College of Physiotherapy
Loni Bk-413736, Tal:Rahata, Dist- Ahmednagar
Maharashtra State, India.
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8275034001 |
| Fax |
|
| Email |
deepali.hande@pmtpims.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ketki Kunjarkar |
| Designation |
Post Graduate |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
OPD no 404,Department of Community Physiotherapy,Dr.A.P.J.Abdul Kalam College of Physiotherapy
Loni Bk-413736, Tal:Rahata, Dist- Ahmednagar
Maharashtra State, India.
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8975159157 |
| Fax |
|
| Email |
ketkikunjarkar05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Community Physiotherapy, Dr. APJ Abdul Kalam College of Physiotherapy, Loni. |
| Department of Obstetrics and Gynecology, Pravara Medical Trust, Loni |
|
|
Primary Sponsor
|
| Name |
Dr Ketki Kunjarkar |
| Address |
Dr.A.P.J.Abdul Kalam College of Physiotherapy
Loni Bk-413736, Tal:Rahata, Dist- Ahmednagar
Maharashtra State, India. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ketki Kunjarkar |
Dr.A.P.J.Abdul Kalam College of Physiotherapy |
Department of Community Physiotherapy,Dr.A.P.J.Abdul Kalam College of Physiotherapy
Loni Bk-413736, Tal:Rahata, Dist- Ahmednagar
Maharashtra State, India.
Ahmadnagar
MAHARASHTRA |
8975159157
ketkikunjarkar05@gmail.com |
| Dr Ketki Kunjarkar |
Pravara Medical Trust |
Department of Obstetrics and Gynecology, Pravara Medical Trust, Loni
Ahmadnagar
MAHARASHTRA |
8975159157
ketkikunjarkar05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) of Pravara Institute of Medical Sciences (Deemed University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A Conventional exercises |
Warm-Up Phase
Breathing Exercises(Deep breathing techniques for oxygenation and relaxation)
Thoracic Expansion Exercises(Gentle chest expansion movements to enhance respiratory efficiency and prepare for exercise)
Mild Stretching(Stretches for key muscles (hip adductors, hamstrings, calves, pectorals, shoulders, upper trapezius) to loosen muscles and improve flexibility)
Main Phase
Aerobic Walking(Comfortable-paced walking to improve cardiovascular health and maintain fitness)
Pelvic Floor Strengthening(Static back Pelvic Bridging, Kegel exercises focusing on contraction and relaxation to strengthen pelvic floor muscles )
Strengthening with Light Weights (Upper and lower limb strengthening using 0.5 kg sandbags, with progressive intensity)
Cool-Down Phase Relaxation Techniques (Progressive muscle relaxation Jacobsons relaxation visualization)
|
| Intervention |
Group B Birthing Ball (BB) exercises |
Warm Up (Circular movements, rocking forward, backward, and sideways while seated on the birthing ball (BB))
Upper Body Strength (Holding the BB while seated on the floor, performing strength building exercises)
Core Strengthening (Quadruped position on hands and knees, engaging the transversus abdominis muscle using the BB)
Lumbar Spine Flexibility (Standing with hands resting on the BB, moving the spine in multiple directions (forward, backward, side to side))
Oblique Strength (Strengthening exercises for oblique muscles while seated on the BB)
Relaxation & Visualization (Semi reclined position on the BB with guided relaxation and visualization techniques)
Cardiovascular Activity (Moderate intensity exercises like Seated Marching, Stationary Cycling, and Low Impact Step Ups with and without the BB respectively)
Pelvic Mobility (Large amplitude pelvic movements in positions such as sitting, standing with hands on the BB, or kneeling with one knee on the BB) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women aged over 18 - 35 years, nulliparous, in their third trimester (more than or equal to 28 weeks of gestation), with a singleton pregnancy, and cephalic presentation
No major obstetric complications and normal extremities allowing the performance of activities
Willing to participate in the study and provide written informed consent
|
|
| ExclusionCriteria |
| Details |
High-risk pregnancies (e.g., preeclampsia, gestational diabetes, placenta previa).
Known fetal anomalies or complications. Previous uterine surgery or history of cesarean delivery.
Medical conditions limiting participation in physiotherapy (e.g., musculoskeletal disorders, cardiovascular issues).
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total Duration of Labor,Type of Delivery, Apgar Scores measured at 5 minutes after birth
|
Total Duration of Labor – At delivery (Day 0)
Type of Delivery – At delivery (Day 0)
Apgar Score – At 5 minutes after birth (Day 0) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Labor Pain Intensity (Visual Analog Scale - VAS)
Perception of Childbirth (MPCS - Maternal Perception of Childbirth Scale)
Rate of NICU Admissions |
Labor Pain Intensity (VAS) – Within 24 hrs after delivery
Perception of Childbirth (MPCS) – Within 24 hrs after delivery
Rate of NICU Admissions – At birth (Day 0) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/09/2025 |
| 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="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The rising prevalence of labor complications and cesarean deliveries calls for simple, safe, and cost effective interventions to support natural childbirth. Birthing ball exercises have shown potential in reducing pain, shortening the duration of labor, and enhancing maternal satisfaction, yet their use in routine antenatal care remains limited. This study aims to compare the effectiveness of birthing ball exercises with conventional physiotherapy in improving maternal and neonatal outcomes among antenatal women. The objectives are to evaluate maternal outcomes such as duration of labor, type of delivery, intensity of labor pain, and perception of childbirth along with neonatal outcomes including Apgar score at five minutes and the rate of NICU admissions. The research question focuses on whether birthing ball exercises are more effective than conventional physiotherapy. The null hypothesis states that no significant difference exists between the two groups while the alternative hypothesis proposes a significant difference in outcomes. |