| CTRI Number |
CTRI/2025/05/086543 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of ankle stability in swimmer by doing balance exercise |
|
Scientific Title of Study
|
Effectiveness Of Proprioceptive Training On 50m Freestyle Swimming Performance and Ankle Instability in Competitive Swimmers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhuvanashree P |
| Designation |
PG Student |
| Affiliation |
SRM College of Physiotherapy |
| Address |
Room number PT:22, 4th floor,SRM College of Physiotherapy,SRM Medical College Hospital and Reseach Centre, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8525925475 |
| Fax |
|
| Email |
bhuvanariv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T N Suresh |
| Designation |
Vice Principal |
| Affiliation |
SRM College of Physiotherapy |
| Address |
Room NO PT:2,5th floor,SRM college of physiotherapy, SRM medical college hospital and research centre, SRM Institude of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
99411111872 |
| Fax |
|
| Email |
sureshn@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr T N Suresh |
| Designation |
Vice Principal |
| Affiliation |
SRM College of Physiotherapy |
| Address |
Room NO PT:2,5th floor,SRM college of physiotherapy, SRM medical college hospital and research centre, SRM Institude of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
99411111872 |
| Fax |
|
| Email |
sureshn@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy SRM Institute of science and technology kattankulathur chengalpattu district Tamil Nadu India 603203 |
|
|
Primary Sponsor
|
| Name |
BhuvanashreeP |
| Address |
Room no: PT 22, IV Floor, SRM college of physiotherapy, SRM medical college building, SRM institute of science an technology, kattankulathur Chengalpattu district Tamilnadu India 603203
|
| Type of Sponsor |
Other [Self funded] |
|
|
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 R Mohana Krishnan |
SRM Sports department |
Ground floor,C-Block backside to dental college,SRM department of sports, SRM Institute of sciences and technology, kattankulathur chengalpattu district, Tamilnadu India 603203
Kancheepuram
TAMIL NADU |
044 27417281
mohanakr@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Ankle instability |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
proprioceptive training |
1st week single-leg stance 10repx3 sets, single-leg stance while swinging the raised leg10repx3sets, Single-leg squat (30°-45°)10repx3reps, Open Single-leg stance while performing functional activities 10repx3set for 3days per week (dribbling, catching) all in eye open in Bosu ball or wobble board. 2nd week single-leg stance 10repsx3sets, swinging the raised leg 10repsx3sets, single-leg squat 10repsx3sets (30°-45°) eye closed for 3days per week. 3rd week single-leg stance 10repsx3sets, swinging the raised leg 10repsx3sets, single-leg squat (30°-45°), Double-leg stance while rotating the board open eye 10repsx3sets for 3 days per week. 4th week single-leg stance with eye closed 10repsx3sets, swinging the raised leg10repsx3sets, single-leg squat (30°-45°) 10repsx3sets, single leg stance while rotating the board with open eye 10repsx3sets for 3days per week. 5th week single-leg stance 10repsx3sets, single-leg squat 10repsx 3sets, single-leg stance while rotating the board10repsx3sets, single leg stance while performing functional activities (dribbling, catching) 10repsx3sets for 3days per week. |
| Comparator Agent |
strengthening exercise |
push-up, pull-up, dumbbell rows,
shoulder press, biceps curls,
squats, lunges, leg press, calf rises, core exercise. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Ankle instability under the grading scale of functional ankle instability questionnaire
less than 61 points to 100 points. No current history of any lower extremities surgery or recent injury.
Minimum 2 years of swimming experience.
|
|
| ExclusionCriteria |
| Details |
Severe ankle injury or replacement surgery.
Symptoms of mechanical low back pain, knee pain , uncontrolled core stability.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The 50m freestyle swimming performance. Calculate factor like Speed= Distance/Time (m/s) and Timing in seconds. (reliability= 0.99)
|
5weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional Ankle Instability (FAI). ( reliability=0.96).
|
5weeks |
Star Excursion Balance test (SEBT). (reliability= 0.84-0.92)
|
5weeks |
|
|
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)
|
23/06/2025 |
| 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="5"
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
|
Getting informed consent from the participants for the study - The study will be clearly explained in layman’s terms or regional language and informed consent will be obtained. The sample of 30 are to be selected within the age group of 15-32 years male and female participants (Holland B et al.,2019, Doherty C et al., 2018) the treatment session were to be performed for 5week. Then the participants are asked to provide the Demographic data along with functional ankle instability questionnaire (FAI) and Star excursion balance test (SEBT) which provide the basic analysis of participants current condition, ankle stability and proprioception level of the participants. Participants are made to do 50m freestyle swimming note the time in seconds and speed (m/s) of the participant as a pre-test analysis and after that proprioceptive training protocol has given to the participants for 1-5 weeks as per the intervention goes for 3 times in a week. After 5-week protocol completed then the participant made redo the 50m freestyle swimming, FAI and SEBT as the post-test analysis. This study was conducted at the SRMIST, Kattankulatur. The pre-test will be taken with questionnaire, clinical measure and swimming session. Further proprioceptive training protocol such as for 1st week single-leg stance, single-leg stance while swinging the raised leg, Single-leg squat (30°-45°), Open Single-leg stance while performing functional activities (dribbling, catching) all in eye open in bosu ball or wobble board. 2nd week single-leg stance, swinging the raised leg, single-leg squat (30°-45°) eye closed. 3rd week single-leg stance, swinging the raised leg, single-leg squat (30°-45°), Double-leg stance while rotating the board open eye. 4th week single-leg stance with eye closed, swinging the raised leg, single-leg squat (30°-45°), single leg stance while rotating the board with open eye. 5th week single-leg stance, single-leg squat, single-leg stance while rotating the board, single leg stance while performing functional activities (dribbling, catching). Follow them in online contact to check their continuation of exercises. Participants are following up in person for once in a week. At the end of the 5th week post-test will be taken by reassuring with 50m freestyle swimming speed & time, FAI and SEBT to rule out the result. |