| 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] |
|
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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 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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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, |
|
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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. |
|
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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. |