| CTRI Number |
CTRI/2024/11/076691 [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
|
Survey to Understand Dressing Challenges for Women with Upper Limb Orthopedic conditions in Southern Karnataka |
|
Scientific Title of Study
|
Developing and piloting a survey questionnaire on factors influencing dressing among women with upper extremity musculoskeletal conditions in Southern Karnataka - A cross sectional study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Manish Chavda |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9148112986 |
| Fax |
|
| Email |
pooja.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shovan Saha |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Occupational Therapy, 3rd Floor, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9880059426 |
| Fax |
|
| Email |
shovan.saha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Manish Chavda |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9148112986 |
| Fax |
|
| Email |
pooja.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Occupational Therapy, KMC Hospital, Manipal, Karnataka, India Pin Code 576104 |
|
|
Primary Sponsor
|
| Name |
Pooja Manish Chavda |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions (MCHP), MAHE, Manipal, Karnataka, India. Pin Code: 576104 |
| 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 |
| Dr Shovan Saha |
Kasturba Medical College Hospital (KMC Hospital) |
Department of Occupational Therapy , A V Baliga Block, First floor, N1 Block, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, India. Pin Code 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
women with upper extremity musculoskeletal conditions in India
women of age 18 to 60 yrs
women who have been having the condition for more than 3 months |
|
| ExclusionCriteria |
| Details |
women who have undergone recent surgeries and are in acute stage
women with neurological conditions
women with mental health conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The survey questionnaire developed and validated will be used as the primary outcome measure to identify the factors that influence dressing in Southern Karnataka women with upper extremity musculoskeletal conditions. |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
25/11/2024 |
| 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="0"
Months="2"
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
|
Title: Developing and piloting a survey questionnaire on factors influencing dressing among women with upper extremity musculoskeletal conditions in Southern Karnataka. Type of Study: Prospective cross-sectional study. Study Aim: To identify the factors affecting dressing among South Karnataka women with upper extremity musculoskeletal conditions. This involves developing and validating a survey questionnaire. Justification: Dressing is a crucial daily activity tied to personal independence. Women with upper extremity musculoskeletal conditions often face challenges in this area, which can affect their quality of life. The study focuses on understanding these difficulties in an Indian context, specifically in Southern Karnataka. Study Period: July 2024 – March 2025. Sample Size: 18 participants will be selected using purposive sampling. Methodology: Inclusion Criteria: Women aged 18-60 with upper extremity musculoskeletal conditions lasting over three months. Exclusion Criteria: Women with recent surgeries, neurological or mental health conditions. Study Phases: 1. Questionnaire Development Based on literature, anecdotal evidence, and clinical experience, a survey will be developed focusing on factors influencing dressing. 2. Content Validation A panel of occupational therapists will review the questionnaire to ensure its relevance and accuracy. 3. Pilot Study Conducted among 18 participants using an online survey. Data will be analyzed using descriptive statistics. Outcome Measures: The validated questionnaire will assess the factors influencing dressing among the target group. Potential Risks and Benefits: Minimal risk. Ethical considerations include informed consent, confidentiality, and data protection. This project aims to contribute to occupational therapy by addressing a gap in the research on dressing challenges among women with specific musculoskeletal conditions in India.
|