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CTRI Number  CTRI/2020/10/028444 [Registered on: 16/10/2020] Trial Registered Prospectively
Last Modified On: 12/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding the Relationship between the Disability and Hobby in people with hand injury 
Scientific Title of Study   Correlation between disability severity and leisure satisfaction in people with hand injury 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Louis Sunny 
Designation  Student 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Department of Occupational Therapy, 3rd floor, MCHP, Manipal

Udupi
KARNATAKA
576104
India 
Phone  07022132071  
Fax    
Email  louissunny715@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shovan Saha 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Dept. of Occupational Therapy, 3rd floor, MCHP, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880059426  
Fax    
Email  shovan.saha@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shovan Saha 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Dept. of Occupational Therapy, 3rd floor, MCHP, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880059426  
Fax    
Email  shovan.saha@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Louis Sunny 
Address  Dept. of Occupational Therapy, 3rd floor, MCHP, MAHE, Manipal 
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 
Louis Sunny  Kasturba Hospital, Manipal  Department of Occupational Therapy, Baliga block
Udupi
KARNATAKA 
07022132071

louissunny715@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  >Both males and females will be included.
>Age: participants of 18 years and above.
>Any hand injury is distal to the elbow joint based on Modified Hand Injury Severity Scale (MHISS) criteria.
>Subjects will be included at least 6 weeks post immobilization.
>The patient should be able to read and understand English.
>The patient should have pursued any leisure activity before the injury.
>The involved hand should be used in carrying out leisure activity.
>The patient should have participated in the same leisure activity after 6 weeks of immobilization.
 
 
ExclusionCriteria 
Details  >Any associate congenital anomalies of hand.
>Any associate neurological disorders.
>Any clinically diagnosed psychological or cognitive issues
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Leisure satisfaction will be assessed by using Leisure Satisfaction Scale  15 to 20 minutes to administer the questionnaire.
The Leisure Satisfaction Scale (LSS) evaluates the extent to which individuals feel that their needs are met through their leisure activities. Categories of effects of participation are used as the component parts and subscales of the LSS. These are: psychological, educational, social, relaxational, physiological and aesthetic. The items are rated on a 5-point Likert scale from ‘Almost never true for you’ to ‘Almost always true for you’.
 
 
Secondary Outcome  
Outcome  TimePoints 
Disability Severity will be assessed by DASH scale  15 to 20 minutes to administer the questionnaire.
Questionnaire contains 30-item which are designed to evaluate the patients health status during their preceding week. These items are scored based on five responses (no difficulty, mild, moderate, severe difficulty and unable to perform), in this total DASH score ranges from 0-100 (0-indicates no disability, 100-indicates severe disability). 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="47" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/10/2020 
Date of Study Completion (India) 23/03/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="11" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study is a cross-sectional study to find out the correlation between disability severity and leisure satisfaction which will be conducted on 56 patients with hand injury. The selection of participants would be done according to the inclusion and exclusion criteria and the participants would be recruited from Dept. of Occupational Therapy, Kasturba Hospital. Participants with hand injury will be included in the study based on the description of the MHISS (Modified Hand Injury Severity Score).

Then, DASH (Disability of the arm, shoulder, and hand) and Leisure Satisfaction Scale would be administered. The data would be collected followed by summarizing and analyzing data. Further Statistical analysis would also be done. During this period, thesis writing would begin followed by Submission.

Depending upon the outcome this study may help in the understanding of leisure satisfaction among people with hand injuriesThis study may also help in understanding the extent of disability and how it influences leisure satisfaction among people with hand injuries.

For the data analysis SPSS version- 16 will be use for data analysis. Descriptive statistics will be conducted to identify if the data is normally distributed. If normally distributed, parametric tests for correlation (Pearson’s correlation test) will be used. If data is not normally distributed then non parametric test for correlation (Spearman’s rank correlation test) will be used.

 
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