| CTRI Number |
CTRI/2021/03/032186 [Registered on: 22/03/2021] Trial Registered Prospectively |
| Last Modified On: |
19/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
impact of immersive virtual reality based rehabilitation on functional independance and health realted quality of life after distal radius fracture: single blinded randomized control trial |
|
Scientific Title of Study
|
Impact of immersive virtual reality-based rehabilitation on functional independence and health related quality of life after distal radius fracture. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tasneem Burhani |
| Designation |
Post graduate student |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha |
| Address |
Ravi Nair Physiotherapy College, Department of Community Health Physiotherapy, DMIMS (DU), Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8668287286 |
| Fax |
|
| Email |
tapsburhani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Waqar M Naqvi |
| Designation |
Vice Principal, Head of Department, Community Health Physiotherapy, Ravi Nair Physiotherapy College |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha |
| Address |
Ravi Nair Physiotherapy College,DMIMS (DU), Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9021699000 |
| Fax |
|
| Email |
waqar.naqvi@dmimsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Tasneem Burhani |
| Designation |
Post graduate student |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha |
| Address |
Ravi Nair Physiotherapy College, department of community health physiotherapy, DMIMS (DU), Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8668287286 |
| Fax |
|
| Email |
tapsburhani@gmail.com |
|
|
Source of Monetary or Material Support
|
| datta meghe institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Tasneem Burhani |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi Meghe Wardha |
| 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 |
| Tasneem Burhani |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences |
department of community health physiotherapy
Wardha
MAHARASHTRA |
8668287286
tapsburhani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| datta meghe institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M249||Joint derangement, unspecified. Ayurveda Condition: distal radius fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapy |
control group will be treated with conventional physiotherapy. which will include wrist mobilization, IFT, wrist strengthening exercises |
| Intervention |
immersive virtual reality |
impact immersive virtual reality in patients with distal radius fracture. This is compared with conventional physiotherapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients with distal radius fracture
age 18 years and above
conservatively managed patients
ability to recognize and obey verbal instructions |
|
| ExclusionCriteria |
| Details |
bilateral fractures
malignant conditions
osteoarthritis of wrist joint
past trauma
rheumatic and neurological conditions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
range of motion
muscle strength
michigan hand questionnaire
DASS 21
DASH questionnaire
|
6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS scale
FIM scale |
30 mins |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/03/2021 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
study protocol has been published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This trial will be done to assess the impact of immersive virtual reality in patients with distal radius fracture. And this will be compared with conventional therapy. The findings of the trial will provide an insight whether virtual reality has an impact in patients with distal radius fracture. |