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CTRI Number  CTRI/2024/08/072550 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 31/12/2025
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   A comparative study on effectiveness of proprioceptive and balance training versus strengthening exercise with common use of Maitland mobilization for the treatment of chronic ankle instability in athletes 
Scientific Title of Study   Effectiveness of proprioceptive and balance training versus strengthening exercise with common use of Maitland mobilization for the treatment of chronic ankle instability in athletes 
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 Kalyan Roy 
Designation  Master of Physiotherapy Student 
Affiliation  Burdwan institute of medical and life sciences 
Address  Exercise therapy lab,ground floor, department of physiotherapy, Burdwan institute of medical and life sciences, university campus, Golapbag, Burdwan-713104

Barddhaman
WEST BENGAL
713104
India 
Phone  8820382365  
Fax    
Email  ptroykalyan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Amartya Mallick 
Designation  Assistant Professor 
Affiliation  Burdwan institute of medical and life sciences 
Address  Exercise therapy lab,ground floor, department of physiotherapy, Burdwan institute of medical and life sciences, university campus, Golapbag, Burdwan-713104

Barddhaman
WEST BENGAL
713104
India 
Phone  9547207113  
Fax    
Email  dr.amartyamallick20@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Priyanka Das 
Designation  Assistant Professor 
Affiliation  Burdwan institute of medical and life sciences 
Address  Exercise therapy lab,ground floor, department of physiotherapy, Burdwan institute of medical and life sciences, university campus, Golapbag, Burdwan-713104

Barddhaman
WEST BENGAL
713104
India 
Phone  8617055472  
Fax    
Email  dr.priyadas03@gmail.com  
 
Source of Monetary or Material Support  
Exercise therapy lab,ground floor, department of physiotherapy, Burdwan institute of medical and life sciences, university campus, Golapbag, Burdwan-713104 
 
Primary Sponsor  
Name  Kalyan Roy 
Address  Exercise therapy lab,ground floor, department of physiotherapy, Burdwan institute of medical and life sciences, university campus, Golapbag, Burdwan-713104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kalyan Roy  Burdwan institute of medical and life sciences  Exercise therapy lab,ground floor, department of physiotherapy, Burdwan institute of medical and life sciences, university campus, Golapbag, Burdwan-713104
Barddhaman
WEST BENGAL 
8820382365

ptroykalyan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of Burdwan Institute of Medical and Life Sciences Bardhaman India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S960||Injury of muscle and tendon of long flexor muscle of toe at ankle and foot level,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PROPRIOCEPTIVE AND BALANCE TRAINING With MAITLAND MOBILIZATION   Proprioception plays an essential role in balance control, and ankle proprioception is arguably the most important. Balance control improvement is one of the most important goals in sports and fitness. Proprioception is defined as ones ability to integrate the sensory signals from various mechanoreceptors to thereby determine body position and movements in space, and it plays a crucial role in balance control. The training of proprioceptive senses is a viable behavioural therapy for improving impaired motor functions. All the movement patterns will be attempted for 5 to 20 repetitions for 1 to 2 times per day and will be continued for 5 sessions in a week up to 4 weeks Maitland mobilization Maitland mobilization is a therapeutic technique where passive oscillatory movements are done in different grades depending on the severity of soft tissue and joint complex involved. It has five grades (Grade I–V) respectively. We will be applying Grade I and Grade II to reduce pain during the treatment session. The translation movements will be applied for 30 seconds, for 15 sets over 10 minutes; after each set, the patient rested in a neutral position for approximately 10 seconds. Each groups will be attended for 5 sessions in a week up to 4 weeks.  
Comparator Agent  STRENGTHENING EXERCISE With MAITLAND MOBILIZATION   STRENGTHENING EXERCISE These are the sets of exercises to be started after restoration of near normal range of motion. The sets of exercise are started from isometric exercise with progression to isotonic exercise as far the as the available range is there. The isotonic exercise is done using manual resistance by the therapist, weights or elastic bands for dorsi flexion/plantar flexion/eversion /inversion (as tolerated) within pain limit. At first light resistance with high repetitions are recommended. strengthening the peroneal muscles is important because reduced eversion strength has been associated with recurrent injury resulting to chronic ankle instability. The progression of exercise regime for the athlete to return to sports should also involve the proximal muscles of hip and trunk. The pressure or contraction will be maintained for 5 to 10 seconds with 10 repetitions in a single set. The treatment will be continued for 5 sessions in a weeks up to 4 week. Maitland mobilization is a therapeutic technique where passive oscillatory movements are done in different grades depending on the severity of soft tissue and joint complex involved. It has five grades (Grade I–V) respectively. We will be applying Grade I and Grade II to reduce pain during the treatment session. The translation movements will be applied for 30 seconds, for 15 sets over 10 minutes; after each set, the patient rested in a neutral position for approximately 10 seconds. Each groups will be attended for 5 sessions in a week up to 4 weeks. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Athletes with chronic ankle instability diagnosed by consultant of ORTHOPAEDICS OR
SPORTS MEDICINE.

2. Unilateral involvement (Right dominant).

3. Age limit: 20 - 25 years.

4. Sex both male and female. 
 
ExclusionCriteria 
Details  1. Recent or any significant fracture or injury in ankle joint.

2. History surgical intervention in ankle joint.

3. Unilateral involvement (Left dominant).

4. Any psychological illness. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Cumberland Ankle Instability Tool (CAIT)  1st day of treatment and after 4 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/08/2024 
Date of Study Completion (India) 26/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

INTRODUCTION

Chronic Ankle Instability is a common and debilitating condition that affects an individual who are engaged in sports or physical activities that involve sudden changes in directions or jumping. They can range from mild tear (such sprains / small tears) to severe (when the ligament is completely torn). Most of the injuries in ankle occur when the players rapidly intend to change directions or lands on uneven surface (eg: grass, fields). This is the most common condition seen in players associated with football, volleyball, net balls and basketball. The quick change in direction and fall causes excessive stress on the ankle joint and its relative ligaments [Deltoid ligament (medially), the Anterior and Posterior Talofibular ligaments and the Calcaneofibular ligament (laterally)] leading to tear or a rupture of one or more ligament. This type injury can have significant negative effects on an individual’s performance, physical health, mental wellbeing and quality of life.

Proprioceptive and Balance training : It is a type of approach where the individual is trained to gain the motor control and functions. This method of treatment focus on improving functional stability which is carried on a stable platform progressing to an unstable platform with various functional activities on hard surface, foam surface, wobble board, trampoline, balance board.

Strength training : It is the development of muscle strength which plays an integral component of most rehabilitation or conditioning programs for individual of all ages and abilities. Strengthening exercise is an activity in which dynamic or static contraction is resisted by an external force either manually or mechanically.

Maitland mobilization : It is a type of manual therapy used in physical therapy that involves passive movements of joints and soft tissues to reduce pain, improve range of motion, and restore normal function. Maitland mobilization involves the therapist using their hands to apply graded Oscillatory movements to the joint or tissue being treated, with the goal of restoring range of motion and joint mobility in patients with chronic ankle instability.

 

Need for the study

Chronic ankle instability are relatively common injuries among athletes. They occur most frequently in those who play sports involving pivoting (example: football, volleyball, basketball, netball, rugby, gymnastic, downhill skiing).

In this study, an effort will be made to find out the effectiveness of the Proprioceptive and Balance training and Strengthening exercise with common use of Maitland mobilization to treat chronic ankle instability in athletes.

Though there is limited documented research comparing the two approaches with common use of Maitland mobilization

 

OBJECTIVE OF RESEARCH:

1.  1. To evaluate the effectiveness of Proprioceptive and Balance Training with Maitland mobilization for the treatment of chronic ankle instability athletes.

2.  2.    To evaluate the effectiveness Strengthening exercise with Maitland mobilization for the treatment of chronic ankle instability in athletes.

3.  3.    To compare the effectiveness of Proprioceptive and Balance training versus Strengthening exercise with common use of Maitland mobilization for the treatment of chronic ankle instability in athletes.

 

RESEARCH HYPOTHESIS


 NULL HYPOTHESIS (H0): 

There will be no significant difference between the Effectiveness of Proprioceptive and Balance training versus Strengthening exercise with common use of Maitland mobilization for the treatment of chronic ankle instability in athletes.

ALTERNATIVE HYPOTHESIS (H1): 

There will be significant difference between the Effectiveness of Proprioceptive and Balance training versus Strengthening exercise with common use of Maitland mobilization for the treatment of chronic ankle instability in athletes.

 

Expected Outcome:

Both the groups are expected to show significant improvement after 4 weeks of rehabilitation with Chronic Ankle Instability. The proposed study must find out whether both the interventions are statistically significant or not as well as which group will show significant statistical functional independence. 
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