| CTRI Number |
CTRI/2025/10/096261 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Balance training for sports players with unstable ankles. |
|
Scientific Title of Study
|
Efficacy of instrument based balance and proprioceptive exercises on kinesiophobia among individuals involved in contact sports with ankle instability. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti Doshi |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University, P.O.Limda, Tal.Waghodia,Dist.Vadodara, Gujarat.
Vadodara GUJARAT 391760 India |
| Phone |
9049310703 |
| Fax |
|
| Email |
shrutidoshi565@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dhwani Jani |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University,P.O.Limda, Tal. Waghodia,Dist. Vadodara, Gujarat.
Vadodara GUJARAT 391760 India |
| Phone |
8469578811 |
| Fax |
|
| Email |
dhwani.jani29352@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Shruti Doshi |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University, P.O.Limda, Tal.Waghodia,Dist.Vadodara, Gujarat.
Vadodara GUJARAT 391760 India |
| Phone |
9049310703 |
| Fax |
|
| Email |
shrutidoshi565@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul University,P.O.Limda, Tal. Waghodia,Dist. Vadodara, Gujarat,India 391760 |
|
|
Primary Sponsor
|
| Name |
Shruti Doshi |
| Address |
Parul Institute of Physiotherapy,P.O.Limda, Tal. Waghodia,Dist. Vadodara, Gujarat,India 391760 |
| Type of Sponsor |
Other [Physiotherapy] |
|
|
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 |
| Shruti Doshi |
Parul Institute of Physiotherapy |
Room No.18.2,1st floor,Orthopedic Physiotherapy department,Parul Sevashram Hospital,P.O.limda,Tal. Waghodia,Dist.Vadodara,Gujarat. Vadodara GUJARAT |
9049310703
shrutidoshi565@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
contact sports players |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MEND balance board exercises |
Through MEND while maintaining balance and reaching targets like touching the dots shown on the screen which keep changing by shifting weight without moving from the place in training mode using dynamic balance exercises progressing weekly by changing time and radius. |
| Comparator Agent |
Wobble board balance exercises |
With wobble board next to wall for support while maintaining the balance rotating the wobble board clockwise and anticlockwise alternately without lifting the heel or bending forward for specific time. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Individuals within the age group of 18 to 35 years
Contact sports players kabaddi martial arts football hockey wrestling kho kho taekwondo boxing
Ankle instability score of Identification of Functional Ankle Instability greater than 11 kinesiophobia at moderate to high level
Previous ankle sprain injury at least one foot and in last one year
|
|
| ExclusionCriteria |
| Details |
Ankle or foot deformities
Open wounds
People unable to follow instruction
Having any neurological problem
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tampa scale of kinesiophobia (TSK-17), Identification of Functional Ankle Instability |
pre-baseline
post-4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
01/11/2025 |
| 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="6" 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
|
Sports-related injuries, especially ankle injuries, are common due to the joint’s weight-bearing role and the dynamic movements required in sports. Recurrent ankle ligament injuries can cause joint instability, often leading to kinesiophobia — a debilitating fear of movement and re-injury.Kinesiophobia negatively affects athletes both physically (impaired proprioception, reduced strength, decreased ROM) and psychologically (anxiety, depression, lower quality of life). It is commonly seen post-injury or post-surgery, delaying return to play and affecting rehabilitation outcomes.The study aims to evaluate the effectiveness of instrument-based balance and proprioceptive exercises in reducing kinesiophobia among contact sport athletes with ankle instability. participants screened according to inclusion and exclusion criteria. informed consent before the intervention. pre assessment of kinesiophobia using tampa scale .instrument based balance and proprioceptive exercises for individuals with kinesiophobia. post assessment of kinesiophobia using tampa scale of kinesiophobia.. statistical analysis and results. |