| CTRI Number |
CTRI/2025/10/095703 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Special Exercise Program for new mothers to reduce abdominal pain ,improve strength,balance and functional activities . |
|
Scientific Title of Study
|
Effectiveness of Proprioceptive Neuromuscular Facilitation(PNF) programme on abdominal pain,strength,balance and Functional activity in postpartum women. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Supreet Kaur |
| Designation |
MPT orthopaedics student |
| Affiliation |
Guru Nanak Dev University ,Amritsar |
| Address |
Department of Physiotherapy,1st floor,room no-4,Guru Nanak Dev University,Amritsar.
Amritsar
PUNJAB
143005
India |
| Phone |
9877849392 |
| Fax |
|
| Email |
supreetkaursandhu1899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Poonam Chaturvedi |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University,Amritsar |
| Address |
Department of Physiotherapy,ground floor,room no-1,Guru Nanak Dev University,Amritsar.
Amritsar
PUNJAB
143005
India |
| Phone |
9451149311 |
| Fax |
|
| Email |
Poonamchaturvediphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Chaturvedi |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University,Amritsar |
| Address |
Department of Physiotherapy,ground floor,room no-1,Guru Nanak Dev University,Amritsar.
Amritsar
PUNJAB
143005
India |
| Phone |
9451149311 |
| Fax |
|
| Email |
Poonamchaturvediphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Dev University,GT Road,Amritsar,PIN-143005,Punjab,India. |
|
|
Primary Sponsor
|
| Name |
Supreet Kaur |
| Address |
VPO chiddan tehsil ajnala ,amritsar,PIN-143107,Punjab,India. |
| Type of Sponsor |
Other [Self] |
|
|
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 Amritpal Kaur |
Guru Nanak Dev Hospital |
Department of Obstetrics and Gynaecology,2nd floor,Unit 1.
Amritsar
PUNJAB |
9877849392
supreetkaursandhu1899@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Guru Nanak Dev University,Amritsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Propriceptive Neuromuscular Facilitation |
Total 6 sessions of Proprioceptive Neuromuscular facilitation will be given over the period of 3 days ,starting from next day after delivery. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Postpartum women having abdominal pain.
2.Postpartum women having weak abdominals.
3.Postpartum women having balance impairement.
4.Postpartum women having functional activity impairment.
5.Postpartum women between 20 to 35 years of age
6.Primiparous Postpartum women. |
|
| ExclusionCriteria |
| Details |
1.Postpartum women having abdominal pain,abdominal weaknes,balance impairement,functional impsirement due to reasons other than pregnsncy.
2.Postpartum women under anaesthesia.
3.Postpartum women having any fractures.
4.Postpartum women having seizures. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in abdominal pain,weakness,balance and functional activity at the end of PNF pragramme |
Relevant Data will be collected just before the 1st session(1day),after 3rd session(2nd day) and after 6th session(3rd day) of entire PNF Program. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| patient satisfaction levels with interventions |
data for patient satisfaction levels will be collected on 3rd day i.e. at termination of entire PNF Programme. |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
01/11/2025 |
| 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="6"
Days="0" |
|
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
Modification(s)
|
This is a randomized ,parallel- group controlled trial comparing 54 postpartum women,randomized into two groups :one receiving PNF Programme,the other receiving standard care and advice only over the period of 3 days .Abdominal pain,weakness,balance and functional activity will be measured before and after the completion of programme in both the groups.Participation will be voluntary and written informed consent will be obtained from all the participants.This study will test efficacy of PNF in postpartum recovery over routine standaized care and advice and will provide useful insights to guide future postpartum rehabilitation strategies. |