| CTRI Number |
CTRI/2024/07/069730 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of the effects of short foot exercises and virtual reality on individuals with flexible flat feet. |
|
Scientific Title of Study
|
Effects of short foot exercises and virtual reality on flexible flat foot individuals: A comparative 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 |
Rane Rhea Rajendrakumar |
| Designation |
Post Graduate Student |
| Affiliation |
Nitte Institute of Physiotherapy (NITTE Deemed to be University) |
| Address |
Nitte Institute of Physiotherapy, Nitte (Deemed to be University), Room no. 20, Second based division, Physiotherapy Department,
Deralakatte, Mangaluru, Karnataka, 575018,
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8830403535 |
| Fax |
|
| Email |
rhearane22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanesh Kumar K U |
| Designation |
Professor |
| Affiliation |
Nitte Institute of Physiotherapy (NITTE Deemed to be University) |
| Address |
Nitte Institute of Physiotherapy, Nitte (Deemed to be University), Room no. 20, Second based division, Physiotherapy Department,
Deralakatte, Mangaluru, Karnataka, 575018,
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9019431417 |
| Fax |
|
| Email |
principal.nipt@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rane Rhea Rajendrakumar |
| Designation |
Post Graduate Student |
| Affiliation |
Nitte Institute of Physiotherapy (NITTE Deemed to be University) |
| Address |
Nitte Institute of Physiotherapy, Nitte (Deemed to be University), Room no. 20, Second based division, Physiotherapy Department,
Deralakatte, Mangaluru, Karnataka, 575018,
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
08830403535 |
| Fax |
|
| Email |
rhearane22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Physiotherapy (NITTE Deemed to be University)
Department of Physiotherapy
Room no. 20
Second base division,
Deralakatte, Mangaluru,
Karnataka,
575018,
India |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, Nitte (Deemed to be University),
Room no. 20
Second base division, Deralakatte, Mangaluru, Karnataka, 575018,
India |
| Type of Sponsor |
Other [Nitte Institute of Physiotherapy (NITTE Deemed to be University)] |
|
|
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 |
| Rane Rhea Rajendrakumar |
Nitte Institute of Physiotherapy (NITTE Deemed to be University) |
Physiotherapy department, Room no. 20, Second based division,
Deralakatte, Mangaluru, Karnataka, 575018,
India
Dakshina Kannada
KARNATAKA |
8830403535
rhearane22@gmail.com |
|
|
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 |
| Healthy Human Volunteers |
Individuals with flexible flat foot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Short Foot Exercises |
•The SFE group will be told to perform exercises like
i. Towel curling
ii. Picking up stones and putting in the bowl
iii. Toe walking
iv. Heel walking etc.
v. The intervention will be given for 30 mins
vi. A follow up for the same will be done in both the groups at 3rd month and 6th months and the outcomes will be noted down respectively. |
| Intervention |
Virtual Reality |
•The VR group will be given to perform a few exercises under the supervision of the therapist by using the Vast Rehab Program for 30 minutes.
•The Zed Camera will be used to detect all the joints and biomarkers precisely and allow the participant to understand the movement to be performed more accurately.
•A demo session will be given before the actual exercise starts on the screen which will help the participant understand the exercise/game.
•The participant has to stand on the given mark which will also be displayed on the screen itself.
•Exercises like dodging, weight transfers (forward, backward, right and left), tilting games, kicking, single leg standing etc. will be given
•The intervention will be given 3 times per week, for a total of 4 weeks for 30 minutes.
•A follow up for the same will be done in both the groups at 3rd month and 6th months and the outcomes will be noted down respectively.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with flexible flat foot
2. Navicular drop more than 10mm
3. College students, both males and females; aged between 18 – 25 years
|
|
| ExclusionCriteria |
| Details |
1. Individuals who are not willing to participate
2. Rigid flat foot
3. Any issue involving the soft tissues or bones that impacts the foot or lower extremity
4. Any orthopedic or neurological condition influencing the balance
5. Any prior instances of fracture or trauma that have had an impact on the foot or lower extremity
6. Any visual or auditory impairments that may influence the engagement in virtual reality
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Foot posture index
2.Navicular drop test
3.Y Balance test |
•The outcomes foot posture index, navicular drop test and Y balance test will be noted within & between both the groups before the intervention, after 4 weeks of intervention, 3rd month follow up and 6th month follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pressure Platform |
This outcome will be noted within & between both the groups before the intervention, after 4 weeks of intervention, 3rd month follow up and 6th month follow up. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/02/2025 |
|
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
|
When a person has pes planus, their medial longitudinal arch curves more flatter than usual, causing their entire foot to contact the ground entirely or almost entirely. In order to perform short foot exercises (SFE), one must try to bring the first metatarsal head toward the calcaneus without extending the toes. Previous research has demonstrated the efficacy of Short Foot Exercises in increasing the strength of intrinsic muscles in people with flexible pes planus, improved dynamic balance in a healthy population, improving foot posture and function, and reducing navicular drop. In rehabilitation, the use of gaming in conjunction with a biofeedback system—like virtual reality (VR)—is widespread. This is explained by the VR system’s potential to make therapy more interesting, lessen the difficulties of rehabilitation, and improve general safety. Virtual reality exposure, or VRE, uses computer technology to track participants’ movements and lets them interact with visuals on a TV screen. With the use of this technology, rehabilitation sessions become more entertaining and engaging as participants are encouraged to perform more repetitions. Better outcomes can therefore be attained in a shorter amount of time by doing several fun, repeating sessions. It’s common advice to use virtual reality, especially when discussing orthopedic conditions, to improve cardiovascular health, walking, and postural control. Since no prior research of this kind has been conducted in India, this study will be useful in determining how well virtual reality works for people who have flexible flat feet. Using a ZED camera to assess the VAST Rehab program’s efficacy in treating people with flexible flat feet The regular exercises will be given in a different, more engaging way with virtual reality. Should it demonstrate efficacy within the 18–25 age range, it may also be applied to younger and older populations. The study aims to assess how these interventions enhance balance, navicular drop, and arch height in people with flexible flat feet. |