| CTRI Number |
CTRI/2024/02/062837 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
translation and Validation in Hindi language, social adaptation of Pelvic Girdle Questionnaire |
|
Scientific Title of Study
|
Hindi Translation, Cross-culture adaptation, Validation and Reliability of Pelvic Girdle Questionnaire (PGQ) 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 |
Devendra kumar Dhruv |
| Designation |
PG Student (MPT) |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
General outpatient department (OPD) ,Room no.4, Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
7987397821 |
| Fax |
|
| Email |
devendra.kumar.dhruv96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Manu Goyal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitaion |
| Address |
Room no.1,Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitaion, Maharishi Markandeshwar Deemed to be University,
Mullana .
Ambala
Ambala
HARYANA
133207
India |
| Phone |
07691907845 |
| Fax |
|
| Email |
manugoyal1111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Devendra kumar Dhruv |
| Designation |
PG Student (MPT) |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitaion |
| Address |
General outpatient department, Room no.1, Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitaion, Maharishi Markandeshwar Deemed to be University,
Mullana .
Ambala
Ambala
HARYANA
133207
India |
| Phone |
07987397821 |
| Fax |
|
| Email |
devendra.kumar.dhruv.96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitaion, Maharishi Markandeshwar Deemed to be University,
Mullana, Ambala, Haryana, |
|
|
Primary Sponsor
|
| Name |
Devendra kumar Dhruv |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitaion, Maharishi Markandeshwar Deemed to be University,
Mullana, Ambala, Haryana, Pin code- 133207 |
| 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 Devendra kumar Dhruv |
Maharishi Markandeshwar Institute of Medical sciences and Research Hospital |
General Outpatient Department (OPD), Room no.4,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA |
7987397821
devendra.kumar.dhruv96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe, Maharishi Markandeshwar Institute of Medical Sciences and Research , Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R299||Unspecified symptoms and signs involving the nervous and musculoskeletal systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Age-20-40 years
2.Pregnancy
3.Pelvic girdle pain during pregnancy for more than 15 weeks or within 3 weeeks after delivery. |
|
| ExclusionCriteria |
| Details |
1.Smoking
2.Previous trauma to Lumbopelvic region
3.Skin lesions to Lumbosacral area
4.Chronic Pelvic Diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pelvic Girdle Questionnaire |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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)
|
28/02/2024 |
| 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 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
|
Pelvic girdle pain (PGP) is one of the most common musculoskeletal complaint during pregnancy and postpartum. The Pelvic Girdle Questionnaire (PGQ) is the only condition-specific tool that assesses activity limitations and symptoms in patients with PGP. English, Swedish, French-Canadian, Polish, Iranian, Nepali, Chinese, Urdu, Spanish, Brazilian Portuguese version of PGQ is available for assessment, but no Hindi version of PGQ is yet available for population who only communicate and understand Hindi language. The purpose of this study is to translate and culturally adapt into the Hindi version of the PGQ and to evaluate its reliability and validity. Ethical approval of this study will be taken from the student project committee of Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University). Study will be accordance with Helsinski Declaration Revised 2013. The study will have two phases- 1st PHASE includes- translation and validation of questionnaire according to DE Beaton guidelines . 2nd PHASE includes- cross-cultural adaptation by test-retest reliability. |