| 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
|
|
|
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
|
|
|
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. |