| CTRI Number |
CTRI/2024/05/067971 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study Effect of Virtual Reality Training on Postural Neck Pain in IT Workers. |
|
Scientific Title of Study
|
Effect of Virtual Reality Training on Postural Neck Pain in IT Workers-An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuja Rajendra Wanere |
| Designation |
Intern |
| Affiliation |
Dr.Ulhas Patil College of Physiotherapy |
| Address |
Physiotherapy OPD 207,Khirdi Shivar,Tal And Dist Jalgaon MAHARASHTRA, Jalgaon
Physiotherapy OPD 207,Khirdi Shivar,Tal and district Jalgaon,Jalgaon Maharashtra
425309
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
8668845794 |
| Fax |
|
| Email |
anujarwanere@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mukesh Shinde |
| Designation |
Assistant professor |
| Affiliation |
Dr.Ulhas Patil College of Physiotherapy |
| Address |
physiotherapy OPD 207 Khirdi Shivar, Tal And Dist Jalgaon
Khirdi Shivar,Tal and district Jalgaon,Jalgaon Maharashtra-425309
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
9021047555 |
| Fax |
|
| Email |
MukeshShinde31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukesh Shinde |
| Designation |
Assistant professor |
| Affiliation |
Dr.Ulhas Patil College of Physiotherapy |
| Address |
physiotherapy OPD 207 Khirdi Shivar, Tal And Dist Jalgaon
Khirdi Shivar,Tal and district Jalgaon,Jalgaon Maharashtra-425309
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
9021047555 |
| Fax |
|
| Email |
MukeshShinde31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Ulhas Patil College of Physiotherapy,Khirdi Shivar NH-06,Tal and district Jalgaon -425309 |
|
|
Primary Sponsor
|
| Name |
Anuja Rajendra Wanere |
| Address |
Plot no.14, Shantiniketan Nagar,Sagwan Area,Buldana-443001 |
| 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 Mukesh Shinde |
Dr .Ulhas Patil College of Physiotherapy, Khirdi Shivar ,Jalgaon |
OPD 207,Physiotherapy department,Dr.Ulhas Patil College of Physiotherapy,NH 06, Khirdi shivar tal and dist Jalgaon.
Jalgaon
MAHARASHTRA |
9021047555
MukeshShinde31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr.Ulhas Patil College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postural Neck Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Virtual Reality Training,Neck Mobility Exercises, Isometric Neck Exercises |
Virtual Reality Training with the use of Virtual Reality headset and smartphone.3 sessions each for 2 min with 1 min rest for 3 days/week for 3 weeks.Neck Mobility Exercises includes cervical flexion, cervical extension, cervical rotation,chin tucks,lateral flexion.10 reps 2 sets with 30 sec rest for alternate 3 days/week for 3 weeks.Neck isometric Exercises include Isometric Neck Flexion, Isometric Neck Extension, Isometric Neck Side Bending, Isometric Neck Rotation.10 reps with 10 sec hold for alternate 3 Days/week for 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Non-specific neck pain,Willing to participate in the study,Age 25 – 50 yr,Neck pain of moderate intensity. |
|
| ExclusionCriteria |
| Details |
Traumatic neck pain,Neck pain originating from whiplash,Cervical fracture/dislocation
Cervical spine surgeries,Injuries to the inner ear,Vertebrobasilar insufficiency,Neurological diseases,Vertigo,Dizziness,Nystagmus Motion sickness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck Disability Index(NDI)
Numerical Pain Rating Scale(NPRS) |
At baseline,3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
17/06/2024 |
| 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="0"
Days="21" |
|
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
|
Ethical clearance will be obtained from the institutional ethical committee.Subjects will be screened according to the inclusion and exclusion and age matching criteria. The procedure & purpose of study will be explained to participants. A written informed consent will be obtained from participants. Total 86 subjects will be included in study. After that they will be divided into experimental (43) and control group (43) using simple random sampling lottery method.Neck pain & function will be assessed before treatment using Numerical Pain Rating Scale & Neck Disability Index respectively. Earlier the demographic data, assessment of postural neck pain of each and every individual will be taken.The experimental group will receive conventional neck exercises and virtual reality training in which each participant will perform VR training for 6 minutes.This 6-minute will feature three VR training sessions, each lasting 2 minutes.1 minute rest will be given after each session for 3 days/week for 3 weeks.Control group will receive conventional neck exercises.The post measurements using NPRS & NDI will be taken & results will carried out.
|