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CTRI Number  CTRI/2024/08/073015 [Registered on: 28/08/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
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 Exercise With Mobilization On Pain, Range Of Motion And Foot Posture Index In Ankle Sprain 
Scientific Title of Study   Effect Of Exercise Program Along With Mobilization On Pain , Range Of Motion And Foot Posture Index On Limited Dorsiflexion Post Ankle Sprain 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ravina Ashok Lavhate 
Designation  PG Student 
Affiliation  Dr. A.P.J Abdul Kalam College Of Physiotherapy,Loni 
Address  404 Department of Orthopedic physiotherapy Dr. APJ Abdul kalam College of Physiotherapy
404 Department of Orthopedic physiotherapy Dr. APJ Abdul kalam College of Physiotherapy
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  07218833377  
Fax    
Email  raveenalavhate11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Tejas Surryavanshi 
Designation  Phd Scholar 
Affiliation  Dr. A.P.J Abdul Kalam College Of Physiotherapy,Loni 
Address  OPD 603 Electrotherapy Department DR APJ Abdul Kalam College of Physiotherapy Loni
OPD 603 Electrotherapy Department DR APJ Abdul Kalam College of Physiotherapy Loni
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9552310517  
Fax    
Email  tejaskhitija@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ravina Ashok Lavhate 
Designation  PG STUDENT 
Affiliation  Pravara Institute of Medical Sciences  
Address  orthopedic Department fourth floor DR APJ Abdul Kalam College of Physiotherapy Loni
orthopedic Department fourth floor DR APJ Abdul Kalam College of Physiotherapy Loni
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  07218833377  
Fax    
Email  raveenalavhate11@gmail.com  
 
Source of Monetary or Material Support  
Pravara Institute of Medical Sciences Loni Ahmednagar Maharashtra 
 
Primary Sponsor  
Name  DR APJ Abdul Kalam College Of Physiotherapy Loni 
Address  DR APJ Abdul Kalam College of Physiotherapy Loni talUka Rahata District Ahmednagar 413736 
Type of Sponsor  Private medical college 
 
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 RAVINA ASHOK LAVHATE  Pravara Institute of Medical Sciences  orthopedic Department fourth floor DR APJ Abdul Kalam College of Physiotherapy Loni
Ahmadnagar
MAHARASHTRA 		 07218833377

raveenalavhate11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Pravara Institute of medical sciences (Deemed to be university) Dr. APJ abdul Kalam College of Physiotherapy Loni  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Exercise program  EXERCISE PROGRAM: i. Toe Circles ii. Alphabet Exercises iii. Resisted Dorsiflexion iv. Resisted Plantarflexion v. Resisted Inversion vi. Resisted Eversion vii. Heel Raises Week 1,2 sitting 4 set x 15 reps Week 3,4 long sitting 10 sec x 3 set x 10 reps  
Intervention  Mobilization  1. Mobilization 3set x 6-10 sec 3 times per week 2. EXERCISE PROGRAM: i. Toe Circles ii. Alphabet Exercises iii. Resisted Dorsiflexion iv. Resisted Plantarflexion v. Resisted Inversion vi. Resisted Eversion vii. Heel Raises Week 1,2 sitting 4 set x 15 reps Week 3,4 long sitting 10 sec x 3 set x 10 reps    
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  INCLUSION
1.Age group 18-60years
2. Both Genders
3. Diagnosed case of Ankle sprain
4. Participants willing to participate 
 
ExclusionCriteria 
Details  EXCLUSION
1. History of ankle surgery
2. Lower limb spasticity
3. Refuse to participate or sign informed consent
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain, Range of motion  0 week and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
foot posture index  BASELINE WEEK 0 AND POST WEEK 8 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   07/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
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  
NEED OF STUDY:
The ankle bears more weight per unit area than any other joint in the body. The ankle joint is crucial to the body’s balancing mechanism. The capacity of the bones to hold the central talus bone in place during ankle motion is what determines the stability of the ankle joint. When the foot is flat on the floor, the joint is more stable. Ankle sprains are common injuries that occur among people of all ages and at all activity levels. Numerous ligaments in the ankle help to keep the bones in proper position and stabilize the joint. Joint stability is important for all types of activities, including standing, walking, and running. There has been limited researches about the use of manual therapy methods and their effectiveness in subjects diagnosed with ankle sprain also there is no evidence suggesting that Exercise program with Maitland mobilization can help to improve Range of Motion and Balance in subjects with Sprained Ankle.
Hence, need for my study is to evaluate the combine Effect of Exercise Program along with Mobilization on Pain, Range of Motion and Foot Posture Index on limited Dorsiflexion post  Lateral Ankle Sprain.
Research Question:
 Which among Exercise program along with Mobilization or conventional/Control treatment protocol is beneficial on pain, range of motion and foot posture index  on limited Dorsiflexion post  Lateral Ankle sprain?
HYPOTHESIS:
Null Hypothesis (H0):
There will be no significant Effect of Exercise Program along with Mobilization on Pain, Range of Motion and Foot Posture Index on limited Dorsiflexion post Lateral Ankle Sprain
Alternative Hypothesis (H1):
There will be significant Effect of Exercise Program along with Mobilization on Pain, Range of Motion and Foot Posture Index on limited Dorsiflexion post Lateral Ankle Sprain
AIM:
The aim of this study is to investigate the Effect of Exercise Program along with Mobilization on Pain, Range of Motion and Foot Posture Index on limited Dorsiflexion post Lateral Ankle Sprain
OBJECTIVE:
1. To find out the Effect of Exercise program along with Mobilization on pain in patients on limited dorsiflexion post lateral ankle sprain.
2. To find out the Effect of Exercise program along with Mobilization on range of motion on  limited dorsiflexion post lateral ankle sprain.
3. To find out the Effect of Exercise program along with Mobilization on foot posture index on limited dorsiflexion post lateral ankle sprain.

 
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