| CTRI Number |
CTRI/2025/04/085278 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| 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
|
Effect of strength and balance training among chronic ankle instability athletes |
|
Scientific Title of Study
|
Effects of selective strength training of the peroneus longus and brevis muscles on strength and balance in football players 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 |
Dr.CHONGTIE C |
| Designation |
post graduate student |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
A5 5th floor health science block ,Saveetha college of Physiotherapy ,Saveetha Nagar ,Thandalam,Kancheepuram, Tamil Nadu,602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9363371077 |
| Fax |
|
| Email |
lemlachong@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SSubramanian |
| Designation |
Professor |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
A5 5th floor health science block ,Saveetha college of Physiotherapy ,Saveetha Nagar ,Thandalam Kancheepuram, Tamil Nadu,602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9003913514 |
| Fax |
|
| Email |
subramanian.scpt@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SSubramanian |
| Designation |
Professor |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
A5 5th floor health science block ,Saveetha college of Physiotherapy ,Saveetha Nagar ,Thandalam Kancheepuram, Tamil Nadu,602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9003913514 |
| Fax |
|
| Email |
subramanian.scpt@saveetha.com |
|
|
Source of Monetary or Material Support
|
| A5 5th floor health science block ,Saveetha college of Physiotherapy ,Saveetha Nagar ,Thandalam, Kancheepuram ,Tamil Nadu 602105 |
|
|
Primary Sponsor
|
| Name |
Chongtie C |
| Address |
A5 5th floor health science block ,Saveetha college of Physiotherapy ,Saveetha Nagar ,Thandalam, Kancheepuram, Tamil Nadu 602105 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 |
| Chongtie C |
Saveetha college of Physiotherapy |
A5,5th floor,health science block,Saveetha college of Physiotherapy, saveetha nagar,Thandalam, Kancheepuram Tamil Nadu 605102
Kancheepuram
TAMIL NADU |
9363371077
lemlachong@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 |
| Patients |
(1) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Rehabilitation for Chronic Ankle Instability. |
Participants performed an exercises consisting of ankle stretching, stationary cycling and ankle band exercise (not targetting any specific muscles).
Frequency: 10 minutes of ankle stretching ,20 min stationary cycling,20 min ankle band exercise.3 sessions/week
Duration:8 weeks |
| Intervention |
Selective Strengthening exercises for Peroneus Longus and Brevis Muscles. |
All participants performed two types of ankle movements using Thera-band (strength, level +3[black].PL intervention in which a Thera-band was placed on the ball of the foot and pushed out from the contact point,and PB intervention with Thera-band pulled out from the base of the fifth metatarsal, emphasizing external rotation and valgus of the ankle.
Frequency:2 sets of 100 repetition/second,3 sessions/week
Duration:8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
1.More than 1 ankle sprain
2.No sprain in the 6 weeks prior to testing
3.Scored less than or equal to 25 for Cumberland Ankle Instability Tool |
|
| ExclusionCriteria |
| Details |
1.A history of lower extremity surgery.
2.A history of any disease or condition that may influence neuromuscular control.
3.Inflammatory phase after acute injury. |
|
|
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 |
Strength
|
baseline and after 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Balance |
baseline & after 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
27/04/2025 |
| 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="2"
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
|
Study Title: Effect of selective Peroneus muscles strength training on Balance and Strength among Athletes with Chronic Ankle Instability. Background: Chronic Ankle Instability is a frequent issue among athletes, resulting in decreased balance and strength. Effective rehabilitation strategies are needed to target specific muscles groups, such as the Peroneus muscles, to improve balance and strength. Objective: To evaluate the effect of Selective Peroneus Longus and Brevis muscles Strengthening exercises on Balance and Strength in Athletes with Chronic Ankle Instability. Study Design: This is a prospective, randomized controlled trial comparing the effects of Strengthening exercises targeting the Peroneus Longus and Brevis muscles to a Conventional Rehabilitation protocol (Ankle stretching, Stationary cycling, Ankle band exercises) on strength and balance outcomes in athletes with Chronic ankle instability. Interventions: The Experimental group will undergo selective Peroneus muscles strengthening exercises, while the comparative group will perform Conventional rehabilitation exercises. Outcome Measures: Primary outcomes include Strength (Modified Sphygmomanometer) and Balance (Y-Balance Test). Study Population: Athletes aged 18-30 years having CAI. Sample Size and Duration: 34 athletes, with 8 weeks intervention period. Ethical Considerations: The study will be conducted in accordance with ethical guidelines and has received ethical approval from the institutional review board.
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