| CTRI Number |
CTRI/2024/04/065627 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Impact of virtual reality with conventional physiotherapy in Futsal players with ankle sprain.
|
|
Scientific Title of Study
|
Effect of Immersive Virtual Reality in Adjunct to Conventional Physiotherapy on Static balance, Dynamic Balance and Vertical Jump in Futsal Players with Lateral Ankle Sprain: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharat K Rathi |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Department of Sports Physiotherapy, Ravi Nair Physiotherapy College, DMIHER (DU), Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
8888493293 |
| Fax |
|
| Email |
rathibharat46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil U Ramteke |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Department of Sports Physiotherapy, Ravi Nair Physiotherapy College, DMIHER (DU), Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
7619941787 |
| Fax |
|
| Email |
swapnil123.com@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnil U Ramteke |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Department of Sports Physiotherapy, Ravi Nair Physiotherapy College, DMIHER (DU), Sawangi (Meghe)
MAHARASHTRA
442001
India |
| Phone |
7619941787 |
| Fax |
|
| Email |
swapnil123.com@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha, Maharashtra, India
|
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Department of Sports Physiotherapy, Ravi Nair Physiotherapy College, DMIHER, Sawangi (Meghe), Wardha-442001 |
| Type of Sponsor |
Research institution and hospital |
|
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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 Bharat K Rathi |
Acharya Vinoba Bhave Rural Hospital, Ravi Nair Physiotherapy College |
Department of Sports Physiotherapy, Ravi Nair Physiotherapy College, DMIHER, Sawangi (Meghe)
Wardha
MAHARASHTRA |
8888493293
rathibharat46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DMIHERÂ (DU) |
Approved |
|
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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 |
| Intervention |
Conventional Physiotherapy |
The control group in the study received standard physical therapy treatment tailored to the grade of ankle sprain. For Grade I sprains, the regimen consisted of taping for preventive measures against first-time sprains, along with neuromuscular and balance training. This training involved progressing from double leg standing with closed eyes to single leg standing with open and closed eyes, along with reach outs. The frequency of this regimen was three times a week for four weeks.
For Grade II sprains, the treatment included a more comprehensive approach. This involved therapeutic exercises focusing on range of motion (ROM) for ankle and knee joints, stretching exercises for the tibialis anterior (TA) muscle, neuromuscular and balance training, postural re-education, and strengthening exercises. Strengthening exercises included using weights and resistance bands to target dorsiflexion, plantarflexion, eversion, and inversion movements, progressing from active range of motion exercises to resistive workouts. Additionally, intrinsic muscle strengthening exercises were incorporated.
The dosage for Grade II interventions included:
Therapeutic exercises: 10 repetitions for each exercise, one set
Stretching exercises: 30 seconds hold, three sets
Neuromuscular and balance training: 30 reach outs, two sets
Intrinsic muscle strengthening: 10 repetitions for each exercise, two sets |
| Comparator Agent |
Immersive Virtual Reality in Adjunct to Conventional Physiotherapy |
The Interventional Group will undergo a specialized treatment protocol enhanced by immersive virtual reality (VR) gaming. The VR games utilized include "Clean Sheet," "2MD: VR Football," and "LES MILLS BODYCOMBAT."
For Grade I ankle sprains, the treatment involves taping for preventive measures against first-time sprains, along with neuromuscular and balance training. This includes exercises such as double leg standing with closed eyes and progressing to single leg standing with open and closed eyes, as well as reach outs. This regimen will be conducted three times a week within the "Clean Sheet" game environment, comprising 30 reach outs performed in 2 sets.
Grade II sprains receive a more comprehensive intervention. Therapeutic exercises encompass range of motion (ROM) exercises for ankle and knee joints, stretching for the tibialis anterior (TA) muscle, neuromuscular and balance training, postural re-education, and strengthening exercises. Strengthening exercises involve using weights and resistance bands to target various movements. This regimen is integrated into the "2MD: VR Football" game, with exercises such as 10 repetitions of strengthening exercises in one set, 30-second holds for stretching in three sets, and 30 reach outs in two sets. Additionally, within the "LES MILLS BODYCOMBAT" game, 10 repetitions of various exercises are performed in two sets each. |
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
A diagnosis of Lateral Ankle Sprain in accordance with the diagnostic criteria for Ankle Sprain. (Grade I and Grade II) |
|
| ExclusionCriteria |
| Details |
Futsal players with grade III Ankle sprain
Athletes with pre-existing knee and hip injuries and Plantar fasciitis.
Neurological conditions like Cerebellar Ataxia
Non-Futsal Athletes with Lateral Ankle Sprain.
Previous history of Foot Drop
|
|
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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 error scoring system, Y Balance Tool, X Sens |
Baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/04/2024 |
| 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="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 - NO
|
|
Brief Summary
|
1
To evaluate the effect of Immersive Virtual Reality on static
balance, dynamic balance and vertical jump in futsal players with lateral ankle
sprain.
2
To evaluate the effect of conventional training program
on static balance, dynamic balance and vertical jump in futsal players with lateral
ankle sprain.
3
To compare the effect of immersive virtual reality in
combination with conventional training program on static balance, dynamic
balance and vertical jump in futsal players with lateral ankle sprain. |