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CTRI Number  CTRI/2024/02/062610 [Registered on: 14/02/2024] Trial Registered Prospectively
Last Modified On: 08/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Development of New teaching methodology for slow learners 
Scientific Title of Study   Development and Validation of Novel Educational Framework and its Effectiveness on Academic Proficiency in Undergraduate Physiotherapy Students  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rakesh Krishna Kovela 
Designation  Associate Professor, PhD Scholar 
Affiliation  Nitte Institute of Physiotherapy, NITTE(Deemed to be University). 
Address  Department of Physiotherapy, Room Number 20, Second base division, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7204346274  
Fax    
Email  rakesh.krishna@nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dhanesh Kumar K U 
Designation  Professor and Principal 
Affiliation  Nitte Institute of Physiotherapy, NITTE(Deemed to be University) 
Address  Department of Physiotherapy, Room Number 20, Second base division, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9019431417  
Fax    
Email  principal.nipt@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dhanesh Kumar K U 
Designation  Professor and Principal 
Affiliation  Nitte Institute of Physiotherapy, NITTE(Deemed to be University) 
Address  Department of Physiotherapy, Room Number 20, Second base division, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9019431417  
Fax    
Email  principal.nipt@nitte.edu.in  
 
Source of Monetary or Material Support  
Nitte Institute of Physiotherapy, Nitte(Deemed to be University) will provide basic Infrastructure Facilities. No other monitory support is required  
 
Primary Sponsor  
Name  Nitte Institute of Physiotherapy(NITTE Deemed to be University) 
Address  Nitte Institute of Physiotherapy, Deralakatte, Mangaluru, Karnataka, India 
Type of Sponsor  Other [Constituent Physiotherapy Institute of NITTE(Deemed to be University)] 
 
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 Rakesh Krishna Kovela  Nitte Institute of Physiotherapy  Patanjali Hall, First Floor, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA 		 7204346274

rakesh.krishna@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committe, NITTE (Deemed to be University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Students Pursuing Physiotherapy Profession 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Novel Educational Framework  1. How the changes in the life impacts studies/education. 2. capability to correlate physiotherapy theory and practice. 3. Capability of self-directed learning. 4. Ability to critically analyze. 5. Ability to map concepts and working towards expertise. The research scholar will be the first point of contact for any query throughout the study. The final domains and how they reflect in students will be developed after FGD. The intervention duration is 1 hour per day, four days a week for 4 weeks 
Comparator Agent  Traditional Remedial coaching   Remedial coaching will be given to the students on the basis of the following a. Divide the class into small, carefully chosen groups. b. Provide a wide variety of activities, such as free access to library, books, articles etc. b. Pay close attention to how the materials are prepared. d. Let smarter students assist less intelligent ones. b. Encourage students to take part in planning events. g. Provide as much freedom within the predetermined boundaries as possible. g. Be flexible and take the advice of the students. h. Pay attention to how students respond. i. Try to obtain parental cooperation. The intervention duration is 1 hour per day, four days a week for 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Semester I to Semester V Undergraduate students of age 18 years and above of either gender who gives consent and qualifying Potential learner policy of Nitte institute of physiotherapy. (Phase III Experimental phase)
a. Attendance: Students with less than 75% attendance at the end of first term/first internal and failed in any subjects
b. Examination: Students who score less than 50% in first term/first internal examination at least in one subject
c. Mentors: Identifying potential learners through mentors of the institute
d. Students Guidance clinic/ Student wellness center: Identifying slow/potential learners through student wellness center based on the referral by mentor/coordinator/HOI. Involved in ruling out established diagnosis like ADHD and learning disorders
 
 
ExclusionCriteria 
Details  1. Students who are suffering with conditions like ADHD and Learning disorders  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Academic Proficiency through 1. Comparing first and second Sessional marks. 2. Attendance percentage before first sessional and between first and second sessional. 3. Average Learning Gain  Pre and post measurement of Outcome. One day one and at the end of fourth week  
 
Secondary Outcome  
Outcome  TimePoints 
Concentration, Anxiety and Attention span scale (CAAS).   Pre and post measurement of Outcome. One day one and at the end of fourth week 
 
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)   02/04/2024 
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="2"
Months="6"
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  

Educational framework with structured methodology and uniform guidelines exclusively for potential learners is least touched in higher education system exclusively in medical and healthcare education. After the incorporation of competency based medical education system in Indian scenario there is more scope for learning in a learner’s perspective. But, when it comes for a potential learner the exact mechanism to be followed for improving the interest, capability and capacity of the student is not explored. In Physiotherapy profession because of lack of central council, competency-based framework, exclusive guidelines, methodologies, incorporating the additional coaching in regular time table are the vital reasons behind Potential learners in any academic institute. It is not only a burden to student economically, but also restricts his and institute’s growth if left untouched. Thus, there is an utmost important need to develop a Novel structural educational framework which can help student as well as teacher to cope up with their problems in physiotherapy education to improve academic proficiency as well as improve their concentration, attention and reducing anxiety.

The aim of the present study is to Develop and Validate Novel Educational Framework and Determine its Effectiveness on Academic Proficiency in Undergraduate Physiotherapy students

Objectives:

Primary objectives:

1.     To Develop, the Novel Educational Framework for undergraduate Potential learners pursuing physiotherapy through focused group discussion method with students and faculties

2.     To Content validate the developed framework using CVI by experts in physiotherapy education

3.    To find the effectiveness of Novel Educational Framework in comparison to traditional remedial coaching on Academic Proficiency in Potential learners Pursuing Physiotherapy

Secondary Objectives:

1.     To find the effectiveness of Novel Educational framework on Concentration, Anxiety and Attention using CAAS scale (Concentration, anxiety and attention scale) Annexure III

Me  Methodology: The study will be conducted in three phases. In first phase the novel educational framework will be prepared through focused group discussion method on students and facultys. the developed framework will be validated in second phase through content validation. Effectiveness of Novel educational framework will be determined in third phase by comparing with traditional remedial coaching. The final sample size for phase III will be determined after pilot testing on 30 samples. Physiotherapy students who are facing issues in academics and fulfilling the remedial policy are included in the trial. This study will not disturb the regular academic curriculum. Study will be implemented only between formative exams. 

Significance of the study: Potential learners are neglected in higher education because of lack of structured methodology. This study will be helpful in developing a Novel educational framework and also helps in analyzing and assessing the potential learner. Once the framework is developed, it will be validated and its effectiveness will be evaluated in comparison to traditional remedial coaching. Even though remedial coaching is very well established and used by most of the universities, the main lacunae are every teacher will be different in the way their approach towards remedial coaching. If an established structured plan is prepared it can be a valuable source for overcoming the problems faced by Potential learners and as well as teachers. Intervention will be given to the control group if positive outcomes is observed.

 
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