| CTRI Number |
CTRI/2024/07/069825 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of quality of life with hand functions in patients with wrist fracture. |
|
Scientific Title of Study
|
Correlation of quality of life with hand functions in patients with distal end radius fracture at the end of 3 months. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipti Geete |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
OPD Room No. 5, Physiotherapy Department (402), P.T. School and Centre, Seth Dhurmal Bajaj Orthopaedic Centre and Research Institute, KEM Hospital, Acharya Donde Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
dipti_geete@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dipti Geete |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
OPD Room No. 5, Physiotherapy Department (402), P.T. School and Centre, Seth Dhurmal Bajaj Orthopaedic Centre and Research Institute, KEM Hospital, Acharya Donde Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
dipti_geete@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Esha Jain |
| Designation |
Master of Physiotherapy (Musculoskeletal Sciences) |
| Affiliation |
PT School and Centre, Seth GSMC and KEMH |
| Address |
OPD Room No. 5, Physiotherapy Department (402), P.T. School and Centre, Seth Dhurmal Bajaj Orthopaedic Centre and Research Institute, KEM Hospital, Acharya Donde Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
eshajain1720@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.T. School and Centre, Seth GS Medical College and KEM Hospital.Mumbai -400012. Maharashtra. India |
|
|
Primary Sponsor
|
| Name |
Dipti Geete |
| Address |
P.T. School and Centre, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai - 400012. Maharashtra. |
| 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 Dipti Geete |
Seth GS Medical College and KEM Hospital |
OPD Room No. 5, Physiotherapy
Department (402), Seth
Dhurmal Bajaj Orthopaedic Centre and Research Institute,
KEM Hospital, Acharya Donde Marg, Parel. Mumbai
Mumbai
MAHARASHTRA |
02224143435
dipti_geete@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Seth GS Medical College and KEM Hospital |
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: M848||Other disorders of continuity of bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Distal end radius fracture that has occurred 3 months ago. |
|
| ExclusionCriteria |
| Details |
1) Any past history of deformity of the fingers, wrist, forearm, elbow and/or shoulder.
2) History of present or past peripheral nerve injuries of the upper limb.
3) Wrist osteoarthritis
4) Crush injuries/ tendon injuries
5) Complex regional pain syndrome
6) Any associated neurological condition (stroke,
Parkinson’s ,etc)
7) Any history of psychiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Quality of life in patients using the WHOQOL-BREF
scale.
2) Pain using NPRS
3) Hand grip strength using Camry hand dynamometer
4)Hand dexterity by using the Moberg Pickup Test (MPUT)
5) Patient reported outcome measure using Patient-Rated Wrist Evaluation (PRWE) |
At the end of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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)
|
14/08/2024 |
| 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 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
|
Distal end radius fracture is the most common upper limb injury which accounts for 20% of the total fractures that are seen worldwide. These fractures are most commonly seen after the age of 40, with the mechanism of injury being fall on an outstretched hand. In patients with distal radius fracture, motor impairments, such as pain, decreased range of motion, muscle weakness or reduced grip strength, can affect hand function and overall quality of life. Hand function is essential for daily activities such as self-care, work, and leisure activities. This study aims to examine the correlation between quality of life and hand functions in patients with distal end radius fracture at the end of 3 months. 47 patients with distal end radius fracture fulfilling inclusion criteria will be recruited in the study and will be assessed for the following parameters which include Pain using Numerical Pain Rating Scale (NPRS), Hand grip strength using Camry Hand Dynamometer, Hand function using Moberg Pickup test (MPUT), quality of life using the WHOQOL-BREF scale and patient rated outcome using the patient rated wrist evaluation scale (PRWE). All the data will be collected and correlated. Depending upon normality of the data, Pearson’s or Spearman’s correlation test will be chosen. |