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CTRI Number  CTRI/2025/07/090113 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The impact of confidence on daily activities for hand injury patients in India  
Scientific Title of Study   The Relationship Between Activities of Daily Living Performance And Self-Efficacy Among Clients With Hand Injury in India Context 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shejal A Rao 
Designation  Student 
Affiliation  Dr. Ashwath Acharya, Department of Hand Surgery  
Address  Department of Occupational Therapy Manipal College of Health Professions MAHE Manipal Karnataka 576104 India
Department of Hand Surgery, Kasturba Hospital Manipal- 576104 Udupi Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9901074403  
Fax    
Email  shejal.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Koushik Sau 
Designation  Professor 
Affiliation  Dr. Ashwath Acharya, Department of Hand Surgery  
Address  Department of Occupational Therapy Manipal College of Health Professions
Department of Hand Surgery, Kasturba Hospital Manipal-5765014 Udupi Karnataka
Udupi
KARNATAKA
576104
India 
Phone  7760064744  
Fax    
Email  koushik.sau@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Koushik Sau 
Designation  Professor 
Affiliation  Dr. Ashwath Acharya, Department of Hand Surgery  
Address  Department of Occupational Therapy Manipal College of Health Professions
Department of Hand Surgery, Kasturba Hospital, Manipal-576014 Udupi Karnataka
Udupi
KARNATAKA
576104
India 
Phone  7760064744  
Fax    
Email  koushik.sau@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions MAHE, Manipal, 576104 Karnataka India 
 
Primary Sponsor  
Name  Manipal College of Health Professions 
Address  Manipal College of Health Professions MAHE, Manipal, 576104 Karnataka India 
Type of Sponsor  Research institution and hospital 
 
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 
Shejal A Rao  Kasturba Hospital  Department of Occupational Therapy, Kasturba Hospital , MAHE Manipal 576104 Karnataka
Udupi
KARNATAKA 
09901074403

shejal.mchpmpl2024@learner.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   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S622||Fracture of first metacarpal bone, (2) ICD-10 Condition: S620||Fracture of navicular [scaphoid] bone of wrist, (3) ICD-10 Condition: S623||Fracture of other and unspecifiedmetacarpal bone, (4) ICD-10 Condition: S625||Fracture of thumb, (5) ICD-10 Condition: S629||Unspecified fracture of wrist andhand,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Clients with acute hand fractures treated surgically
2 Clients with hand injury after cast removal 1-3 months
3 Clients who can read and write either English or Kannada
Clients aged 18 to 60 years
 
 
ExclusionCriteria 
Details  1 Clients with comorbidities (such as head injury etc)
2 Clients with a fracture of the hand associated with nerve injury
3 Clients with bilateral hand fractures
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
DASH questionnaire to be administered
General self-efficacy questionnaire to be administered 
DASH questionnaire to be administered after surgery i.e within week 1 to week 13
General self-efficacy questionnaire to be administered after surgery i.e within week 1 to week 13 to get the baseline data 
 
Secondary Outcome  
Outcome  TimePoints 
To record & observe the relationship between self-efficacy & activities of daily living performance among clients with hand injury in India   The outcome will be measured & assessed at baseline i.e within week 1 to week 13 after surgery 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   15/07/2025 
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="1"
Months="0"
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  

Aim: The aim of the study is to find the relationship between activities of daily living performance and self-efficacy among clients with hand injuries in Indian context

 

Justification for study: Enhancing self-efficacy empowers clients to take an active role in recovery, fostering independence in ADLs and improving their quality of life. It also explains whether self-efficacy influences a client’s ADL performance after a hand injury. Therapists can tailor more client-centered interventions that may enhance confidence in their abilities leading to better ADL outcomes

 

Tools used:

·        Generalized self-efficacy scale: This is a self-reported measure administered to adults. It has 10 items and reflects optimistic self-belief. The scorings are not at all true 1, hardly true 2, moderately true 3, and exactly true 4. This scale has good internal consistency and criterion validity.

·        Disabilities of arm, shoulder, and hand (DASH): This is a self-reported measure administered to adults with upper extremity musculoskeletal disorders or injuries. The components of this scale include physical functioning, social/role functioning, and optional modules such as sports or performing arts and work. The scoring criteria is no difficulty 1, mild difficulty 2, moderate difficulty 3, severe difficulty 4, and unable 5. It has good internal consistency and construct validity

 

Detailed description of procedure: Initially, Departmental Research Committee of Occupational Therapy, MCHP approval will be obtained. Permission will be obtained from the authors will be sought to translate and use both scales. Subsequently, approval from the Institutional Research Committee will be obtained. Translation of generalized self-efficacy scale to Kannada will be done, which includes simple forward and backward translation by the two each subject expert for Kannada as well as English. After the Institutional Ethics Committee approval, the Registration in Clinical Trials Registry-India will be done. Based on the inclusion criteria clients with hand injuries will be selected using the convenience method of sampling from the Department of Occupational Therapy, Manipal. Study participants will be provided information regarding the study process and informed consent will be obtained from each participant before participating in the study. Both scales will be given to the study participants and they will then complete the pen-and-paper-based self-administered scales. Data will be analyzed using statistical analysis, JAMOVI software version 2.3.Furthermore, findings will be documented, followed by writing the dissertation, and then submission of the dissertation will be done, followed by manuscript preparation and submission to the appropriate journal.

 

 
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