| CTRI Number |
CTRI/2023/11/059788 [Registered on: 14/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/11/2023 |
| 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
|
Comparing Tele-Rehab and Virtual Reality for Lower Back Pain: Which Therapy Works Better |
|
Scientific Title of Study
|
A comparative study on clinical aspects of Tele-rehabilitation and virtual reality therapies in patients with lower back pain |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharat Bhushan |
| Designation |
Associate Professor |
| Affiliation |
G D Goenka University |
| Address |
School of Medical and Allied Sciences, B- Block, G.D. Goenka Univerisity, Gurugram
Gurgaon
HARYANA
122102
India |
| Phone |
9729021111 |
| Fax |
|
| Email |
drbbhushan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamran Ali |
| Designation |
Associate Professor |
| Affiliation |
G D Goenka University |
| Address |
School of Medical and Allied Sciences, B- Block, G.D. Goenka Univerisity, Gurugram
Gurgaon
HARYANA
122102
India |
| Phone |
9540686786 |
| Fax |
|
| Email |
kamran.ali@gdgu.org |
|
Details of Contact Person
Public Query
|
| Name |
Bharat Bhushan |
| Designation |
Associate Professor |
| Affiliation |
G D Goenka University |
| Address |
School of Medical and Allied Sciences, B- Block, G.D. Goenka Univerisity, Gurugram
Gurgaon
HARYANA
122102
India |
| Phone |
9729021111 |
| Fax |
|
| Email |
drbbhushan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharat Bhushan (Principal Investigator)
|
| Navya ortho Physiotherapy & Rehabilitation Center, 2/22 Spring field Colony, Sec 31 Faridabad |
| Neuromotion Faridabad, 2548, Sec -16, Faridabad |
| Physiotherapy OPD, Dept of Physiotherapy, School of Medical & Allied Science, G D Goenka University, Sohna Road, Gurugram |
| Rehab Hub G-228, GF Sushant Lok-II, Near Hong Kong Bazar Sector-57, Gurugram, Haryana |
|
|
Primary Sponsor
|
| Name |
Bharat Bhushan |
| Address |
Research Scholar, School of Medical and allied sciences, B-block, G D Goenka University, Gurugram |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| kamran Ali |
G D Goenka Univerisity OPD |
Physiotherapy OPD, B-Block, School of Medical and allied sciences, GD Goenka University Campus, Sohana Road, Gurugram-122103
Gurgaon
HARYANA |
9540686786
kamran.ali@gmail.com |
| Dr Monika |
Navya Ortho Physiotherapy & Rehabilitation Center |
Plot no 2, Block no 22, Spring field colony Sector-31, Faridabad-121003
Faridabad
HARYANA |
9467941525
monika.chawla12@gmail.com |
| Dr Sandeep Chauhan |
Neuromotion Faridabad |
2548, Sector-16, Faridabad
Faridabad
HARYANA |
9999015242
drschauhan9@gmail.com |
| Dr Udey Kumar Yadav |
Rehab Hub |
G228, GF, Sushant Lok-II, Near Hong Kong Bazar, Sec-57, Gurugram, Haryana
Gurgaon
HARYANA |
9990698999
rehab.hub.ggn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| GDGU Research Ethics Committee approval for Study at GDGU OPD |
Approved |
| Navya Ortho Physiotherapy & Rehabilitation Center Faridabad |
No Objection Certificate |
| Neuromotion Faridabad |
No Objection Certificate |
| Rehab Hub |
No Objection Certificate |
| Waves Women Empowerment Trust, Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Spinal exercises |
The Proposed protocol will be implemented for 5 days in the week for total of 6 weeks. Back exercises that are given by the orthopaedics surgeons/ Physiotherapist for the relief of the Lower back pain |
| Intervention |
Tele-Rehabiliation |
The Proposed protocol will be implemented for 5 days in the week for total of 6 weeks. All the Back exercises are prescribed as the part of Tele -rehab(instruction that are give via computer/telephone) for the relief of Low back pain |
| Intervention |
Virtual Reality Exercises |
The Proposed protocol will be implemented for 5 days in the week for total of 6 weeks. Back exercises that are given with Virtual reality headset so patient may have the feeling of doing exercises in some another environment. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patient with suffering from low back pain since more than 2 weeks duration.
Those who gave their consent for participating in the present study(Tele rehabilitation or Virtual reality), and ready to undergo 6
weeks of treatment. |
|
| ExclusionCriteria |
| Details |
Alternative treatment regarding back pain and/or sciatica (e.g. surgery, nerve blocks, analgesic medication)
Non-spine related or soft tissue problems potentially.
Associated with back pain or sciatica (e.g. pregnancy, spinal tumor, rheumatoid arthritis)
History of spinal operation, vertebral fracture or dislocation
Severe neurological deficit or symptoms (e.g. cauda equina syndrome). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tele-Rehab or Virtual reality Spinal exercises which one is better then the general exercises given to relieve lower back pain |
Outcome will be assessed/estimated i.e. at baseline, 3 weeks & 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| we will assess the feasibility of Tele-Rehab Treatment over the face to face treatment sessions |
At the end of the study |
| we will assess the feasibility of Virtual Reality treatment over the face to face treatment sessions |
At the end of the Study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
19/11/2023 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drbbhushan@gmail.com].
- For how long will this data be available start date provided 08-10-2023 and end date provided 07-10-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The research study titled "A comparative study on clinical aspects of Tele-rehabilitation and virtual reality therapies in patients with lower back pain" aims to investigate and compare the effectiveness of two modern healthcare interventions, tele-rehabilitation and virtual reality therapy, in managing lower back pain.
Tele-rehabilitation involves remote guidance and monitoring of exercises and treatments by healthcare professionals, allowing patients to access rehabilitation services from their homes. Virtual reality therapy utilizes immersive digital environments to engage patients in therapeutic exercises and activities.
The study seeks to determine which of these two approaches, tele-rehabilitation or virtual reality therapy, yields better clinical outcomes in terms of pain reduction, functional improvement, and overall patient satisfaction. By comparing the effectiveness of these innovative therapies, the research aims to contribute valuable insights into the management of lower back pain and enhance the quality of care provided to patients experiencing this common musculoskeletal condition.
Patients recruitment will be from the Delhi-NCR Region primarily the GD Goenka OPD will be the Central data collection center. and all the patients will file the consent physically. Monitoring patient compliance with exercises in both virtual reality
(VR) and tele-rehabilitation (tele-rehab) settings is crucial for the
success. for that patients will be observed for the compliance of the exercises that are prescribed in either of the group but the Tele-Rehab patients will be doing in the particular room allotted and will be instructed via Tele/computer means while the virtual reality patients will be performing in the another room specified and exercises will be done in virtual environment.
all the patients will be randomly selected by computer to one of the three groups for the research for 6 weeks.
Groups1(Control Group)- General Spinal exercise for Back pain which are prescribed by the Physiotherapist
Group2(TR Group)- Spinal exercises are given via Computer /Tele-phone and paitents will perform themselves. Group3(VR Group)- Spinal exercise are performed in the virtual reality environment by the individual himself.
Pre and Post data will be collected. Data will be recorded for the further analysis of the Research Outcomes which includes:
• Pain
• Disability
• Strength
• ROM
• Quality of Life
• Sleep
• Functional scale
|