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
|
|
Primary Sponsor
|
Name |
Louis Sunny |
Address |
Dept. of Occupational Therapy, 3rd floor, MCHP, MAHE, Manipal |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
|
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
|
|
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
|
|
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 injuries. This
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. |