| CTRI Number |
CTRI/2025/02/080917 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of a 6-Week Physiotherapy Program vs. Conventional Treatment on Strength, Balance, and Proprioception in Sub-Elite Cricket Players with Chronic Ankle Instability. |
|
Scientific Title of Study
|
Effect of a 6-weeks detailed physiotherapy protocol vs. conventional treatment on functional muscle strength, balance and proprioception among sub-elite cricket players with chronic ankle instability- a randomized control trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krupa S Tailor |
| Designation |
PG student |
| Affiliation |
S.S Agrawal Institute of Physiotherapy and Medical Care Education Navsari |
| Address |
MSK out patient department ground floor, S.S Agrawal Institute of Physiotherapy, Devina Park Society, Gandevi Road, Navsari, Gujarat 396445
Navsari
GUJARAT
396445
India |
| Phone |
919328746953 |
| Fax |
|
| Email |
kt7298946@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shlesha Vaidya |
| Designation |
I/C Principal, PhD Scholar, PG Guide and Associated professor |
| Affiliation |
S.S Agrawal Institute of Physiotherapy and Medical Care Education Navsari |
| Address |
MSK out patient department ground floor, S.S Agrawal Institute of Physiotherapy, Devina Park Society, Gandevi Road, Navsari, Gujarat 396445
Navsari
GUJARAT
396445
India |
| Phone |
919427285250 |
| Fax |
|
| Email |
drsmvaidya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krupa S Tailor |
| Designation |
PG student |
| Affiliation |
S.S Agrawal Institute of Physiotherapy and Medical Care Education Navsari |
| Address |
MSK out patient department ground floor, S.S Agrawal Institute of Physiotherapy, Devina Park Society, Gandevi Road, Navsari, Gujarat 396445
Navsari
GUJARAT
396445
India |
| Phone |
919328746953 |
| Fax |
|
| Email |
kt7298946@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.S Agrawal Institute Of Physiotherapy and Medical care Education, Agrawal college campus out patient department, Navsari, Gujarat 396445 |
|
|
Primary Sponsor
|
| Name |
Krupa S. Tailor |
| Address |
325 Darjiwad, At-post Salej, Taluka-Gandevi District-Navsari 396350 |
| 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 Shlesha Vaidya |
S.S Agrawal Institute of Physiotherapy and Medical Care Education. |
MSK OPD Ground floor S.S Agrawal Institute of Physiotherapy, Devina Park Society, Gandevi Road, Navsari, Gujarat 396445
Navsari
GUJARAT |
919427285250
drsmvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,S.S Agrawal Institute of Physiotherapy and Medical Care Education |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Control Group |
-Ankle Isometric Exercise: 1 set of 10 repetitions twice daily for all movements that is Plantarflexion, Dorsiflexion, Inversion and Eversion.
- Heel Raise: 1 set of 10 repetitions twice daily
- Toe Raise: 1 set of 10 repetitions twice daily
- Toe Curling Exercise: 1 set of 10 repetitions twice daily
- One Leg Standing Exercise: 1 set of 10 repetitions twice daily.
|
| Intervention |
Experimental Group |
Strengthening Protocol
1. TheraBand Strengthening Exercises
Primary Movements:
Dorsiflexion
Inversion
Eversion
Each position is held for 6 seconds per repetition, with weekly progression through increased sets, repetitions, or resistance.
Weekly Progression (TheraBand Exercises):
Week 1: Green band, 3 sets of 10 repetitions
Week 2: Green band, 4 sets of 10 repetitions
Week 3: Blue band, 3 sets of 10 repetitions
Week 4: Blue band, 4 sets of 10 repetitions
Week 5: Black band, 3 sets of 10 repetitions
Week 6: Black band, 4 sets of 10 repetitions
Plantar Flexor Strengthening (Heel Raises)
Weekly Progression (Heel Raises):
Week 1: 2 sets of 10 repetitions
Week 2: 2 sets of 15 repetitions
Week 3: 3 sets of 10 repetitions
Week 4: 3 sets of 15 repetitions
Week 5: 4 sets of 10 repetitions
Week 6: 4 sets of 15 repetitions
2. Balance and Proprioceptive Training
(i) Hop-to-Stabilization Training
Week 1:
Side-to-side hops (both legs)
Forward-backward hops (both legs)
Forward hops (both legs)
Figure 8 hops (both legs)
Zigzag hops (both legs)
Square hops (both legs)
Box drill (both legs)
All exercises are performed with hands free, focusing on coordination and balance.
Week 2:
Side-to-side hops (one leg)
Forward-backward hops (one leg)
Forward hops (one leg)
Figure 8 hops (one leg)
Zigzag hops (one leg)
Square hops (one leg)
Box drill (one leg) with arms crossed
Exercises are now performed on one leg, with arms crossed during the box drill to challenge core stability.
Week 3:
Side-to-side hops (one leg) with arms crossed
Forward-backward hops (one leg) with arms crossed
Forward hops (one leg) with arms crossed
Figure 8 hops (one leg) with arms crossed
Zigzag hops (one leg) with arms crossed
Square hops (one leg) with arms crossed
Box drill (one leg) with arms crossed
By week 3, all exercises are performed on one leg with arms across the chest, engaging core muscles.
Week 4:
Side-to-side hops (one leg) with hands behind head
Forward-backward hops (one leg) with hands behind head
Forward hops (one leg) with hands behind head
Figure 8 hops (one leg) with hands behind head
Zigzag hops (one leg) with hands behind head
Square hops (one leg) with hands behind head
Box drill (one leg) with hands behind head
In week 4, exercises are performed with hands behind the head to further engage the core.
Week 5:
Same exercises as Week 4
Continue with hands behind head for all exercises to maintain progression in balance and core strength.
Week 6:
Same exercises as Week 4
In week 6, maintain exercises with hands behind the head to solidify progress.
(ii) BOSU Ball Training
Exercises on BOSU Ball:
-Squats
-Ball Catch and Throw
Each exercise is performed for 10 repetitions, with a 1-minute rest between sets. This training aims to improve dynamic stability and overall coordination. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
-Patient age 14-30 years.
-Both male and females.
-Patient with history of ankle injury or at least one ankle sprain before 12 months.
-Patient with H/O recurrent ankle sprain with last episode at least 3months prior.
-Patient with H/O complains of feeling ofgiving away or ankle instability.
-Sub-elite players registered with the grade cricket club for at least 1 year.
-CAIT Score less than 24.
|
|
| ExclusionCriteria |
| Details |
•Patient with H/O surgeries to the musculoskeletal structures in lower limbs.
•Patient with H/O fracture in the lower limb.
•Patient with H/O acute injury to musculoskeletal structures of other joints of lower extremity in the previous 3 months that impacted the joint integrity and function.(21)
•Patient with other neurological or cardiorespiratory disorder that affects the balance, proprioception or functional ability of the patient.
•Patient unwilling to participate.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Side hop test
2 Star excursion balance test
3 Balance error scoring system |
Each outcome will be assessed at day 1 and after 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcome |
0 |
|
|
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)
|
24/02/2025 |
| 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
|
AIM AND OBJECTIVES:· The aim of the study is 6-week detailed physiotherapy protocol v/s conventional treatment on muscle strength, balance and proprioception in sub-elite cricket players with chronic ankle instability. |