| CTRI Number |
CTRI/2025/05/086592 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study to check two-week program of different kind of balance training on athletes to improve change of direction and their athletes performance between age of 18-30 years |
|
Scientific Title of Study
|
Efficacy of a Two week static and Dynamic balance retraining programme for enhancing agility performance and physical functional activity among athletes aged between 18-30 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHARATH K H |
| Designation |
Professor and Principal |
| Affiliation |
Mangala College of Physiotherapy |
| Address |
Room No 40
Department of Physiotherapy Ground floor Vidyanagara Pademale post
Neermarga Mangalore 575029
Dakshina Kannada KARNATAKA 575029 India |
| Phone |
9886749118 |
| Fax |
|
| Email |
khbharath@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
BHARATH K H |
| Designation |
Professor and Principal |
| Affiliation |
Mangala College of Physiotherapy |
| Address |
Room No 40
Department of Physiotherapy Ground floor Vidyanagara Pademale post
Neermarga Mangalore 575029
KARNATAKA 575029 India |
| Phone |
9886749118 |
| Fax |
|
| Email |
khbharath@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
BHARATH K H |
| Designation |
Professor and Principal |
| Affiliation |
Mangala College of Physiotherapy |
| Address |
Room No 40
Department of Physiotherapy Ground floor Vidyanagara Pademale post
Neermarga Mangalore 575029
KARNATAKA 575029 India |
| Phone |
9886749118 |
| Fax |
|
| Email |
khbharath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mangala College of Physiotherapy
Room No 39
Outpatient Department
Vidyanagara Pademale post
Neermarga Mangalore 575029 |
|
|
Primary Sponsor
|
| Name |
Bharath K H |
| Address |
Mangala college of Physiotherapy
Room No 40
Department of Physiotherapy Vidyanagar Pademale post
Mangalore 575029 |
| Type of Sponsor |
Other [Self sponsored for the study ] |
|
|
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 Bharath K H |
Mangala College of Physiotherapy |
Room No 39
Outpatient Department
Department of Physiotherapy Vidyanagar pademale post
Neermarga Mangalore 575029 Dakshina Kannada KARNATAKA |
9886749118
khbharath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ehtics Committe, IGTAMSU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dynamic balance retraining |
week one will be performed in firm surface
week two will be performed in foam surface
exercises are as follows
Tandem standing with ball catch throws 20 reps x two sets
One leg cone touch in multiple directions
Single leg squats and reach outs
|
| Intervention |
static balance retraining |
static balance exercise program
week one with eyes open
week two with eyes closed
each session consists of 10 reps and 2 sets with a duration starting from 5 sec to 15 sec holds at the end of the second week.
The load increase is achieved by the increase in holding time
The rest period between the sets is determined as one minute
standing on one foot (right and left)
tree pose (right and left)
lifting the leg upto 90 degrees from the front in proper position (right and left) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
18-30 years aged young male and female athletes |
|
| ExclusionCriteria |
| Details |
Recent musculoskeletal injuries (within the last 6 months) involving the lower limbs, spine, or joints affecting mobility or balance. History of neurological disorders including epilepsy, stroke, multiple sclerosis, or any condition affecting proprioception or motor control. Vestibular or inner ear disorders including vertigo, labyrinthitis. Uncorrected visual impairments that significantly affect balance or spatial orientation. Cognitive impairments, Pregnancy, Recent surgeries (within the last 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
T Test & Illinois Agility Test (Agility)
Stork Stand Test (Static Balance)
Y Balance Test (Dynamic Balance)
|
baseline and at the end of two week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lower Extremity Functional Performance Test
Tampa Kinesiophobia scale
|
baseline & at the end of two week |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="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
|
Agility training
and balance retraining are given to athletes separately to improve agility
performance and stability. There is a dearth of knowledge about the importance
of balance retraining on agility improvement. So current study is to evaluate
the effects of a two-week static and dynamic balance training program on
agility performance and physical functional activities in athletes aged 18 to
30 years Primary Objective: - To find out the efficacy of balance retraining programme on agility performance and physical function activity among athletes aged between 18-30 years. Secondary Objectives: - - To find out the reaction time of lower limb following the balance training programme among athletes aged between 18-30 years. To find out the relationship between agility training over static and dynamic balance retraining programme. |