| CTRI Number |
CTRI/2025/07/091325 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Elastic tubing versus proprioceptive training on balance and fear of movement among college athlete with chronic ankle instability |
|
Scientific Title of Study
|
Compare the effectiveness of elastic tubing versus proprioceptive training on balance and fear of movement among college students with 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 |
Bharath Raj A |
| Designation |
PG student |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
A5 5th floor Health science block, Saveetha College of Physiotherapy, Saveetha Nagar, Thandalam, Kancheepuram 602105
A5 5th floor Health science block, Saveetha College of Physiotherapy, Saveetha Nagar, Thandalam, Kancheepuram 602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7305468795 |
| Fax |
|
| Email |
bharathwarrior77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vinodh Kumar R |
| Designation |
Professor |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
A5 5th floor Health science block, Saveetha College of Physiotherapy, Saveetha Nagar, Thandalam, kancheepuram 602105
A5 5th floor Health science block, Saveetha College of Physiotherapy, Saveetha Nagar, Thandalam, kancheepuram 602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8760563032 |
| Fax |
|
| Email |
vinodhkumar.scpt@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinodh Kumar R |
| Designation |
Professor |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
A5 5th floor Health science block, Saveetha College of Physiotherapy, Saveetha Nagar, Thandalam, kancheepuram 602105
A5 5th floor Health science block, Saveetha College of Physiotherapy, Saveetha Nagar, Thandalam, kancheepuram 602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8760563032 |
| Fax |
|
| Email |
vinodhkumar.scpt@saveetha.com |
|
|
Source of Monetary or Material Support
|
| A5 5th floor Health science block, Saveetha College of Physiotherapy,Saveetha Nagar, Thandalam, Kanchipuram 602105, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Bharath Raj A |
| Address |
A5 5th floor Health science block, Saveetha College of Physiotherapy,Saveetha Nagar, Thandalam, Kanchipuram 602105, Tamil nadu, India |
| 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 Bharath Raj A |
Saveetha College of Physiotherapy |
A5 5th floor Health science block, Saveetha College of Physiotherapy,Saveetha Nagar, Thandalam, Kanchipuram
Kancheepuram
TAMIL NADU |
07305468795
bharathwarrior77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Scientific Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
College athelete |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Elastic tubing |
Front pull exercise:
Step 1: The subject stood on the affected foot
Step 2: flexing the unaffected lower extremity at the hip and knee
Step 3: while pulling the tubing forward (A to B)
Step 4: then slowly returned to the starting position (B to A)
Back pull exercise:
Step 1: The subject stood on the affected foot
Step 2: flexing the unaffected lower extremity at the hip and knee
Step 3: while pulling the tubing backward (A to B)
Step 4: Then slowly returned to the starting position (B to A)
3. Crossover exercise:
Step 1: The subject stood on both the affected and unaffected lower extremities
Step 2: with hip and knees flexed.
Step 3: While balancing on the affected foot, the subject adducted the hip by
crossing the unaffected foot in front of the affected foot (A to B)
Step 4: then slowly returned to the starting position (B to A).
4. Reverse crossover exercise:
Step 1: The subject stood on both the affected and unaffected lower extremities
Step 2: with hip and knees flexed and the unaffected lower extremity adducted in front of
the affected foot
Step 3: While balancing on the affected foot, the subject abducted the hips until the feet
were slightly wider apart than shoulder width (A to B)
Step 4: then slowly returned to the starting position (B to A).
Duration -4weeks |
| Comparator Agent |
Proprioceptive training |
1. Squat:
Step 1: Stand with your hands on the back of your head and your feet shoulder-width apart with
your feet turned out slightly to open the hip joint.
Step 2: Lower your body until your thighs are parallel to the floor.
Step 3: Pause, then return to the starting position
Step 4: Repeat the process
2. One leg balance backward:
Step 1: Stand with your feet hip-width apart and your weight equally distributed on both legs.
Place your hands on the hip lift your leg of the floor and bend it at the back at the knee (A)
Step 2: Hold the position as long as you can maintain good form, up to 30 seconds.
Step 3: Return to the starting position and repeat on the other side. As your balance
improves, increase the number of repetitions.
3. One leg balance forward:
Step 1: Stand on one leg and maintaining the balance without falling
Step 2: keep your back straight and lean forward
Step 3: bending your knee to touch the ground in-front
Step 4: Return to the upright position
4. Single leg deadlift:
Step 1: Stand with your feet shoulder-width apart, pick up dumb-bell and stand straight with core
tight
Step 2: While maintaining a tight core keep your chest up chin tucked in and hold the dumb bell
in your left hand
Step 3: Bend over and extend your right leg behind you, keep your left leg as straight as
possible and try to bring dumb-bell as close as you can to your left foot, return to starting
position.
Duration- 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
At least one acute lateral ankle sprain that occurred more than 12 months ago.
Recurrent sprains in the past 6 months.
Cumberland Ankle Instability Tool score.
Greater than four-centimeter difference in the anterior reach direction
between the legs.
Tampa scale of kinesiophobia score of . |
|
| ExclusionCriteria |
| Details |
Bilateral Ankle Instability.
Neurological deficits.
Ankle surgery history.
Use of Assistive Devices. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cumberland ankle instability tool |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tampa scale of kinesiophobia |
4 weeks |
| Y-Balance scale |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
29/08/2025 |
| 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="1"
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
|
Balance deficits in CAI are linked to weakened muscles and impaired proprioception. Elastic
tubing exercises focus on strengthening ankle muscles using resistance. Proprioceptive
training targets balance and joint awareness to improve neuromuscular control. Both methods
are widely used in rehabilitation but their comparative effectiveness on balance is unclear.
This study aims to compare the effectiveness of elastic tubing versus proprioceptive training
on balance in college students with CAI. |