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CTRI Number  CTRI/2024/11/076708 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 11/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Developing a Questionnaire to Assess Occupational Therapists Knowledge, Attitudes, and Practices in Activities of Daily Living for Individuals with Hand Injuries 
Scientific Title of Study   Development and validation of occupational therapists knowledge, attitude, and practice questionnaire in activities of daily living among individuals with hand injury 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  karthikeyan 
Designation  postgraduate student 
Affiliation  Manipal Academy of Higher Education  
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9944593683  
Fax    
Email  karthikeyan.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Mr Koushik Sau 
Designation  Assistant Professor Senior Scale  
Affiliation  Manipal Academy of Higher Education 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7760064744  
Fax    
Email  koushik.sau@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Mr Koushik Sau 
Designation  Assistant Professor Senior Scale  
Affiliation  Manipal Academy of Higher Education 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7760064744  
Fax    
Email  koushik.sau@manipal.edu  
 
Source of Monetary or Material Support  
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka, India 576104  
 
Primary Sponsor  
Name  karthikeyan E 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka, India 576104 
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 Shovan Saha  Kasturba Medical College and Kasturba Hospital Manipal  N1 Block, Department of Occupational Therapy, Manipal, Udupi, Karnataka, India 576104
Udupi
KARNATAKA 
9880059426

shovan.saha@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (STUDENT RESEARCH)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Occupational therapists who are working with adult hand injury individuals in India 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria for content validation:
1. Occupational therapist who has five years of clinical experience with adult hand injury individuals in India

Inclusion criteria for construct validation:
1. Occupational therapists who are working with adult hand injury individuals in India
2. Occupational therapist practicing in orthopedics with one or more than one year of experience in India
 
 
ExclusionCriteria 
Details  Exclusion criteria for construct validation:
1. Occupational therapists who are working only in academic settings
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Development and Validation of the knowledge, attitude, and practice (KAP) survey questionnaire.  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="149"
Sample Size from India="149" 
Final Enrollment numbers achieved (Total)= "149"
Final Enrollment numbers achieved (India)="149" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2024 
Date of Study Completion (India) 16/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   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  

Aim of the study:  

To develop and validate the occupational therapists knowledge, attitude, and practice questionnaire in activities of daily living among individuals with hand injuries.


Justification for study

In a country as diverse as India, values and beliefs underlying an individual’s culture are known to influence the ADLs they engage in their daily life, and for those individuals, ADL is important; so far, there is no information regarding the Indian occupational therapist practices. These ADLs are important domains an occupational therapist addresses during their treatment. Hence, there is a need


Tools used: 

An online questionnaire will be developed to assess the occupational therapists’ knowledge, attitude, and practice in activities of daily living among individuals with hand injuries.

The questionnaire will consist of four sections: demographics, knowledge, attitude, and practice


Detailed description of procedure:

The study will be conducted in three phases.

In Phase I, after the approval from the IEC, the KAP questionnaire will be developed based on the literature review focusing on three main areas: occupational therapy, hand injury, and activities of daily living. The questionnaire will consist of four sections: demographics, knowledge, attitude, and practice. After that, content and construct validation will be done.

In Phase II, for content validation, occupational therapists and psychologists from India will be selected through personal contacts and college websites and they will be contacted through email. Initially, ten occupational therapists from India will be selected, among them the first five occupational therapists, who have a minimum five years of clinical experience in adult hand injuries, and one psychologist will review the questionnaire. Links to the consent and validation forms will be emailed with instructions. A four-week response period will be allowed, with weekly reminders. If needed, additional experts will be selected from the remaining five therapists. Feedback will be collected, and the questionnaire will be revised accordingly.

In Phase III, for construct validity, occupational therapists will be selected from the AIOTA website, colleges, and LinkedIn profiles and through a snowball sampling methodThe sample size will include 149 occupational therapists from India, selected using convenience and snowball sampling methods. Occupational therapists who treat hand injuries will be eligible to participate. The Exploratory factor analysis will analyze construct validity. Google Forms will format the KAP questionnaire and consent form links, distributed via social media and email. Recipients of the forms will be encouraged further to distribute them among other occupational therapists. Data will be collected in Excel sheets and analyzed using JAMOVI software (version 2.3).

The categorical variables in the study will be described using frequency tables and percentages. The numerical variables will be assessed using mean and standard deviation or median and interquartile range subject to assessments of skewness. Two-sample independent t-test/one-way ANOVA or its non-parametric variants (subject to violation of normality and homogeneity of variance assumption) will be used to facilitate comparisons of the outcome characteristics across groups.
The reliability statistics will be assessed using Cronbach’s alpha and construct validity will be measured using Factor Analysis. The Content Validity Index will enable us to assess the content validity of the structured questionnaire developed in the study. 
All statistical analysis will be carried out at 5% level of significance, 80% power using Jamovi 2.3.28

 
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