| CTRI Number |
CTRI/2019/02/017790 [Registered on: 22/02/2019] Trial Registered Prospectively |
| Last Modified On: |
21/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Quasi Experimental |
| Study Design |
Other |
|
Public Title of Study
|
Trying To Find Out The Link Between The Individuals Idea Of Well-being With The End Results Of Occupational Therapy Treatment For The Patient Who Is Not Able To Bend The Joint Between The Forearm And Arm. |
|
Scientific Title of Study
|
Relationship Between Quality Of Life And The Functional Outcome In Client With Elbow Flexion Stiffness Undergoing Occupational Therapy Intervention. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smrutimeera Sahoo |
| Designation |
Postgraduate Student |
| Affiliation |
School Of Allied Health Science, MAHE, Manipal, Udupi, Karnataka |
| Address |
Department Of Occupational Therapy, SOAHS, MAHE, Manipal, Udupi, Karnataka
Kasturba Hospital, MAHE, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7978957662 |
| Fax |
|
| Email |
smrutimeera1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shovan Saha |
| Designation |
Associate Professor |
| Affiliation |
Department Of Occupational Therapy, SOAHS, MAHE, Manipal, Udupi, Karnataka, |
| Address |
Department Of Occupational Therapy, SOAHS, MAHE, Manipal, Udupi, Karnataka
Kasturba Hospital, MAHE, Manipal, Udupi, Karnataka
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 |
Department Of Occupational Therapy, SOAHS, MAHE, Manipal, Udupi, Karnataka, |
| Address |
Department Of Occupational Therapy, SOAHS, MAHE, Manipal, Udupi, Karnataka
Kasturba Hospital, MAHE, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9880059426 |
| Fax |
|
| Email |
shovan.saha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Occupational Therapy, Kasturba Medical College, Manipal,Udupi,Karnatak |
|
|
Primary Sponsor
|
| Name |
KMC |
| Address |
KMC, Manipal, Udupi |
| Type of Sponsor |
Private 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 |
| Smrutimeera Sahoo |
KMC hospital |
Department of Occupational Therapy, Orthopedic Division
Udupi
KARNATAKA |
7978957662
smrutimeera1995@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: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Age above 18 yrs
Patient with elbow flexion stiffness as a result of traumatic and a traumatic causes (congenital deficits) |
|
| ExclusionCriteria |
| Details |
patient with elbow flexion stiffness with Neuro muscular origin will be excluded |
|
|
Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary outcome is to get the elbow extension range |
after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcome is to get better functional outcome and quality of life |
after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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)
|
28/02/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
I’m doing the study on elbow flexion stiffness. I,m going to recruit the patient with elbow flexion stiffness that is caused out of traumatic and a-traumatic causes other than the neuro muscular origin. I’m going to recrurit the cases above 18 yrs of age, I’m going to give the OT interventions that is splint and conventional therapy. I’m going to take readings of 2 scales those are DASH and WHO-QOL BREF before and after giving the interventions. I’m going to compare those values. |