| CTRI Number |
CTRI/2025/06/089122 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on the Impact of Breathing Pattern and Respiratory Muscle Strength on Static Balance in Sports Players With and Without Chronic Ankle Instability
|
|
Scientific Title of Study
|
Association between breathing pattern, respiratory muscle strength and static balance among sports players with and without chronic 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 |
Keerthivarman A |
| Designation |
Student |
| Affiliation |
SRM College of physiotherapy |
| Address |
SRM College of Physiotherapy, SRM Medical College building ,SRMIST, Kattankulathur.
Chennai
TAMIL NADU
603203
India |
| Phone |
8248404875 |
| Fax |
|
| Email |
keerthivarman407@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof D Anandhi |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
SRM College of Physiotherapy, SRM Medical College Building, SRMIST, Kattankulathur.
Chennai
TAMIL NADU
603203
India |
| Phone |
9884299924 |
| Fax |
|
| Email |
anandhid@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Keerthivarman A |
| Designation |
Student |
| Affiliation |
SRM college of Physiotherapy |
| Address |
SRM College of Physiotherapy, SRM Medical College building ,SRMIST, Kattankulathur.
Chennai
TAMIL NADU
603203
India |
| Phone |
8248404875 |
| Fax |
|
| Email |
keerthivarman407@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Keerthivarman A |
| Address |
SRM College of Physiotherapy, SRMIST, Kattankulathur. 603203 |
| 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 Anandhi PT |
SRM College of Physiotherapy |
Biomechanics PG lab, 5th floor, SRM College of Physiotherapy, SRM Medical College building, SRMIST, Kattankulathur
Chennai
TAMIL NADU |
9884299924
anandhid@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee SRM Medical College Hospital and Research Centre, Kattankulathur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sports person with ankle instability |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
A previous history of at least 1 significant lateral ankle sprain resulting in swelling, pain, and temporary loss of function.
History of feelings of giving way at least twice in the past 6 months
Ongoing perceived ankle instability during daily activities.
A score less than or equal to 25 on the Cumberland Ankle Instability Tool. |
|
| ExclusionCriteria |
| Details |
Participants who do not engage in strenous,moderate or mild physical activities.
Participants with Respiratory diseases (e.g., asthma, COPD).
Any History of lower limb surgeries in the last year.
Participants with cardiovascular disorders, scoliosis, ankylosing spondylitis, or any other musculoskeletal disorders that can affect/alter the function of the respiratory system.
Participants with any balance or vestibular disorder.
Any musculoskeletal and neurovascular injuries and disorders in the past 2 years other than lateral ankle sprains.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ANKLE INSTABILITY ANALYSIS.
BREATHING PATTERN ANALYSIS.
STATIC BALANCE ANALYSIS.
RESPIRATORY MUSCLE STRENGTH ANALYSIS. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
30/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
This cross-sectional study aims to investigate the association between breathing patterns, respiratory muscle strength, and static balance among sports players with and without Chronic Ankle Instability (CAI). CAI is a prevalent condition in athletes, often resulting in impaired proprioception and balance. A total of 42 participants (21 with CAI, 21 controls) will be recruited using the Cumberland Ankle Instability Tool (CAIT). Breathing pattern will be assessed using the HI-LO test, respiratory muscle strength via maximum inspiratory pressure (MIP) with a respiratory pressure meter, and static balance through single-leg stance on a plantar pressure mat. The study seeks to explore whether respiratory function influences balance in CAI-affected athletes, aiming to inform training strategies for injury prevention and improved performance. |