| CTRI Number |
CTRI/2024/07/070074 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Conversion and validation of Hindi version of Boston Carpal
Tunnel Syndrome Questionnaire |
|
Scientific Title of Study
|
Translation and validation of Hindi version of Boston Carpal
Tunnel Syndrome Questionnaire |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amisha |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, E-Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7082258528 |
| Fax |
|
| Email |
amishajanagal528@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Mehra |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, Teaching Staff Room, E-Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Mehra |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, Teaching Staff Room, E-Block, College of Physiotherapy, PGIMS, Rohtak
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Pt. B.D. Sharma, PGIMS, Rohtak, Haryana, India, 124001 |
| Type of Sponsor |
Government medical college |
|
|
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 Suman Mehra |
Pt. B.D. Sharma, PGIMS |
Room No: 5, Lala Shyam Lal Super Speciality Block, Pt. B.D. Sharma PGIMS/UHS, Rohtak
Rohtak
HARYANA |
8814063412
sumanmehra2017@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G560||Carpal tunnel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of carpal tunnel syndrome who have Hindi as their native language.
2. Subject with ability to understand the Hindi language version of Boston Carpal Tunnel Syndrome Questionnaire. |
|
| ExclusionCriteria |
| Details |
1. Non Hindi speaking population.
2. Subjects who do not understand the Hindi language version of Boston Carpal Tunnel Syndrome Questionnaire.
3. Age under 18
4. Any history or clinical sign of polyneuropathy or known hereditary neuropathy with liability to pressure palsies, previous trauma or surgery to the wrist, a history of rheumatoid arthritis, diabetes mellitus, thyroid disease, alcoholism, arthrosis of wrist, pregnancies or severe atrophies of abductor pollicis brevis muscle |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Boston Carpal Tunnel Syndrome Questionnaire |
At baseine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient-rated wrist evaluation score (Hindi version) |
At baseliine |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
10/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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: Translation and validation of Hindi version of Boston Carpal Tunnel Syndrome
Sample Size: 210
Inclusion and exclusion criteria mentioned above.
Observational cross-sectional study |