| CTRI Number |
CTRI/2024/10/075445 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find how the virtual reality based exercises can improve the balance, reduce the risk of fall and improve their activities of daily living and quality of life in pregnant women. |
|
Scientific Title of Study
|
Effectiveness of Immersive Virtual Reality Exercises on Joint Proprioception, Balance, Fall Risk, Functional Mobility, Physical Activity And Quality Of Life In Pregnant Women -A Randomized Controlled 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 |
RADHIKA GOPALS |
| Designation |
Associate Professor |
| Affiliation |
Srinivas Institute of Physiotherapy |
| Address |
Srinivas University campus Pandeshwar.
Department of Pediatrics, Near Neuro physiotherapy OPD, Ground floor
Srinivas University campus Pandeshwar.
Department of Pediatrics, Near Neuro physiotherapy OPD, Ground floor
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9995507379 |
| Fax |
|
| Email |
radhikaradhu1590@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RADHIKA GOPALS |
| Designation |
Associate Professor |
| Affiliation |
Srinivas Institute of Physiotherapy |
| Address |
Srinivas University campus Pandeshwar.
Department of Pediatrics, Near Neuro physiotherapy OPD, Ground floor
Srinivas University campus Pandeshwar.
Department of Pediatrics, Near Neuro physiotherapy OPD, Ground floor
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9995507379 |
| Fax |
|
| Email |
radhikaradhu1590@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RADHIKA GOPALS |
| Designation |
Associate Professor |
| Affiliation |
Srinivas Institute of Physiotherapy |
| Address |
Srinivas University City campus Pandeshwar.
Department of Pediatrics, Near Neuro physiotherapy OPD, Ground floor
Srinivas University City campus Pandeshwar.
Department of Pediatrics, Near Neuro physiotherapy OPD, Ground floor
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9995507379 |
| Fax |
|
| Email |
radhikaradhu1590@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of OBG, Srinivas Hospital, Mukka , Mangaluru.
Department of Physiotherapy , Srinivas University.
Karnataka,India- 575001 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 S Rajasekar |
1. Srinivas Medical college Hospital |
Department of Physiotherapy, Mukka ,Mangalore
Dakshina Kannada
KARNATAKA |
9448156719
rs.rajasheker@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRINIVAS UNIVERSITY ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women who are not having any known pregnancy complications completed the first trimester will be selected for the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional or Routine care |
The participants in the control group will be monitored in their in- situ and will be asked to do their routine physical activities at home and will be asked to follow the general pregnancy care advised by their gynecologist including routine checkups.
This group will be provided with information pamphlets or notices regarding maintaining correct posture while performing daily activities and measures taken in preventing falls. The participants will also be encouraged to do walking |
| Intervention |
Immersive Virtual Reality Exercises |
The experimental group will be receiving the immersive virtual reality training as follows:
1. Spiritual walk: Pregnant women wearing VR glasses will be asked to focus on the spiritual music and the places of worship displayed on the screen and can perform relaxed walking. This can be performed in standing as well as sitting
2.Tribal trek: Pregnant women wearing VR glasses. The participant will be asked to raise the toes off the ground to escort the tribe in the virtual jungle. (activities in Sitting /standing facilitating ankle dorsiflexion).
3.Focus forest: Pregnant women wearing VR glasses should collect the coins that will be coming from different directions on the screen which includes multidirectional movements.
4. Save the Jerry: Pregnant women wearing VR glasses should “focus the Jerry†standing on the ground, as they extend the knee, Jerry can overcome the hurdles.
5. Coastal Saga: Exercises in sitting (phase 1) and later in standing (Phase 2) move the lower limbs in different directions with multipoint activity displayed on the screen.
Exercises will be given from, 13 th to 20 th week of gestation, for thrice a week for 8 weeks.
Total time includes 30-40 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women(primiparous or nulliparous) who have completed 13 weeks of gestation.
Low risk pregnancies with no active maternal or fetal complications.
pregnant women with existing joint reposition error more than 2.5 degree
|
|
| ExclusionCriteria |
| Details |
History of knee or ankle related injuries in the past 6 months.
Any pregnancy related complications like preexisting medical conditions or previous history of multiple abortions.
Women who have been advised to be on bed rest or physically less active.
Pregnant women experiencing hyperemesis, dizziness or vertigo.
Any previous history of preterm labour or miscarriage.
Women who has undergone any lower limb surgeries
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Joint position error measured by smartphone inclinometer |
Baseline at 13 weeks of gestation.
At 20, 24, 28, 32 weeks of gestation during the intervention.
At 6th and 8th week postpartum as follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Balance measured by TUG test
Functional mobility measured by Four square step test.
Fall risk measured by PASRoF
Physical activity measured by Pregnancy Physical Activity Questionnaire.
Quality of Life measured by WHOQOL-bref
|
Baseline at 13 weeks of gestation.
Will be measured once in 4 weeks (at the end of 20,24, 28, 32WGA) for TUG, FSST, Joint reposition test, PPAQ, PASRoF, WHOQOL-Bref followed by 8 weeks of intervention.
Follow up at 6th and 8th week postpartum |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="1"
Months="0"
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
|
Proprioceptive loss during pregnancy is common leading to many problems reflecting in their postpartum. There is lack of evidence suggesting exercises for proprioceptive training in pregnant population. The purpose of the trial is to find the benefits of virtual reality exercises on improving many functional functional outcomes in pregnant women. The participants as per the sample size calculated will be recruited once the CTRI registration is done and enrollment number is received. |