| CTRI Number |
CTRI/2025/10/096514 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Using Virtual Reality vs. Regular Physiotherapy to Regain Balance After an Ankle Sprain. |
|
Scientific Title of Study
|
Effect of Non-Immersive Virtual Reality versus Conventional Physiotherapy on balance in individuals with ankle sprain. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bindhu Bhagavaldas Maniyatta |
| Designation |
Post Graduate Student |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
3rd floor, Ramaiah College of Physiotherapy, M S Ramaiah Nagar, MSRIT Post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
8073583798 |
| Fax |
|
| Email |
bindhudas2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shobhalakshmi S |
| Designation |
Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
3rd floor,Ramaiah College of Physiotherapy M S Ramaiah Nagar, MSRIT Post, Bangalore-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9008025432 |
| Fax |
|
| Email |
shobhaholla.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shobhalakshmi S |
| Designation |
Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
3rd floor, Ramaiah College of Physiotherapy M S Ramaiah Nagar, MSRIT Post, Bangalore-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9008025432 |
| Fax |
|
| Email |
shobhaholla.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah University of Applied Sciences, M S Ramaiah Nagar, MSRIT Post, Bangalore
560054 |
|
|
Primary Sponsor
|
| Name |
Bindhu Bhagavaldas Maniyatta |
| Address |
Ramaiah College of Physiotherapy, M S Ramaiah Nagar, MSRIT
Post, Bangalore-560054 |
| 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 Bindhu Bhagavaldas Maniyatta |
M S Ramaiah University of Applies Sciences |
3rd floor, Ramaiah College of Physiotherapy, M S Ramaiah Nagar,
MSRIT Post
Bangalore
Bangalore
KARNATAKA |
8073583798
bindhudas2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S934||Sprain of ankle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy
|
The participants allocated to the conventional therapy group will receive exercises involving conventional physiotherapy by the primary investigator. The exercises will be similar to that of the NI-VR group.
This will be given for 4 sessions. |
| Intervention |
Non Immersive Virtual Reality |
The participants allocated to the Non-Immersive Virtual Reality(NI-VR) group will be given a NI-VR based protocol using the Rehametrics software via the Microsoft Kinect One device for balance training. This will be given for 4 sessions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Grade 2 and grade 3 ankle sprain
|
|
| ExclusionCriteria |
| Details |
-Any other inflammatory conditions
-Any neurological condition
-Any vestibular dysfunction
-Ocular impairments
-Low back pain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance (4 stage Balance Test) |
Before and After 4 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kinesiophobia (Tampa Scale of Kinesiophobia) |
Before & After 4 sessions |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/11/2025 |
| 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="11"
Days="0" |
|
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
|
Ankle sprain is one of the most common orthopaedic injuries to the lower limb. Post ankle sprain, patients experience a reduction in the muscle strength around the ankle and the range of motion of dorsiflexion, plantarflexion, inversion and eversion. Patients also presented with decreased proprioception and reduced balance. Various methods have been established to improve balance in individuals with ankle sprain such as proprioceptive exercises, neuromuscular control, postural stability exercises, taping and use of virtual reality. This study aims to asses whether conventional physiotherapy is better or use of virtual reality is better. |