| CTRI Number |
CTRI/2024/06/069668 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To prevent Risk of falls In Diabetic Middle Aged Population Using Virtual reality |
|
Scientific Title of Study
|
Effectiveness Of Non Immersive Virtual Reality In Prevention Of Risk Of Falls In Prefrail Diabetic Middle Aged Population A Pre Post 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 |
ArchanaT |
| Designation |
Post graduate student |
| Affiliation |
NITTE institute of physiotherapy |
| Address |
Department of physiotherapy,Room number 20,second based division,NITTE institute of physiotherapy,NITTE(Deemed to be university),Deralakatte Manglore,Karnataka,India
Dakshina Kannada
KARNATAKA
57508
India |
| Phone |
6379322605 |
| Fax |
|
| Email |
Archana03082000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MSRuchita Narsia |
| Designation |
Assistant professor |
| Affiliation |
NITTE institute of physiotherapy |
| Address |
Department of physiotherapy,Room number 20,second based division,NITTE institute of physiotherapy,NITTE(Deemed to be university),Deralakatte Manglore,Karnataka,India
Dakshina Kannada
KARNATAKA
57508
India |
| Phone |
9408956388 |
| Fax |
|
| Email |
ruchita.narsia@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
MSRuchita Narsia |
| Designation |
Assistant professor |
| Affiliation |
NITTE institute of physiotherapy |
| Address |
Department of physiotherapy,Room number 20,second based division,NITTE institute of physiotherapy,NITTE(Deemed to be university),Deralakatte Manglore,Karnataka,India
Dakshina Kannada
KARNATAKA
57508
India |
| Phone |
9408956388 |
| Fax |
|
| Email |
ruchita.narsia@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| NITTE institute of physiotherapy,NITTE Deemed to be university,Deralakatte,Manglore,Karnataka,575018,India |
|
|
Primary Sponsor
|
| Name |
NITTE institute of physiotherapyNITTE Deemed to be university |
| Address |
Department of physiotherapy,Room number 20,second based division,NITTE institute of physiotherapy,NITTE(Deemed to be university),Deralakatte Manglore,Karnataka,575018,India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Archana T |
NITTE institute of physiotherapy |
Department of physiotherapy,Room number 20,second based division,NITTE institute of physiotherapy,NITTE(Deemed to be university),Deralakatte Manglore,Karnataka,575018,India
Dakshina Kannada
KARNATAKA |
6379322605
Archana03082000@gmail.com |
| Ms Ruchita Narsia Assistant professor |
NITTE institute of physiotherapy |
Department of physiotherapy,Room number 20,second based division,NITTE institute of physiotherapy,NITTE(Deemed to be university),Deralakatte Manglore,Karnataka,575018,India
Dakshina Kannada
KARNATAKA |
9408956388
ruchita.narsia@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of NITTE institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non immersive virtual reality |
This intervention have a position sensor and a laptop.The patience are trained using videogames.This Training programme is of 3sessions perweek for 4 weeks,30 minutes of training is done and 2 minutes of rest in between . |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants 40-60 years
2.Participants should have the ability to walk independently or with minimal assistance
3.Participants with normal vision and hearing
4.Participants should be able to follow simple instructions
5.Both the genders
6.Participants with controlled diabetes from past 6 months
7.Participants with a score of 8-11 in Edmonton frail scale |
|
| ExclusionCriteria |
| Details |
1.Participants with balance disorder due to problem of vestibular system and cerebellum
2.Participates in other exercise similar to the intervention
3.Participants with preestablished diagnosis of virtual and hearing impairment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Performance oriented mobility assessment |
my primary outcome measure is used twice during my study once at the baseline and once at 4 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Edmonton frail scale |
This will be used to evaluate baseline characteristics and at 4 weeks after the intervention |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
05/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/02/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
About 5% to 17% of older persons in the geriatric population have frailty,a geriatric syndrome.Frail adults are more likely to have negative health effects.According to the studies,Prefrail individuals have higher chance of improvement than frail population and they will experiance falls at this age.One of the most important effective intervention in prevention of falls is the use of non-immersive virtual reality.studies state that frailty is associated with risk of falls in people with type 2 diabetes |