| CTRI Number |
CTRI/2024/05/067377 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of fear of movement and its impact on the quality of life on individuals undergoing Anterior Cruciate Ligament reconstruction surgery in Goa |
|
Scientific Title of Study
|
Prevalence of Kinesiophobia and its impact on Quality of Life following ACL reconstruction in Goa |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Danica Marlyn Dcunha |
| Designation |
1st year MPT student |
| Affiliation |
Goa Medical College and Hospital |
| Address |
Department of Orthopaedic Goa Medical College and hospital Bambolim Tiswadi Goa
Tiswadi Bambolim Goa
North Goa
GOA
403202
India |
| Phone |
8698074094 |
| Fax |
|
| Email |
danicadcunha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Alisha Gracias |
| Designation |
MPT, PhD, Assistant professor in physiotherapy |
| Affiliation |
Goa Medical College and Hospital |
| Address |
Department of Orthopaedic Goa Medical College and hospital Bambolim Tiswadi Goa
Tiswadi Bambolim Goa
North Goa
GOA
403202
India |
| Phone |
9881887175 |
| Fax |
|
| Email |
alisha.gracias@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Danica Marlyn Dcunha |
| Designation |
1st year MPT student |
| Affiliation |
Goa Medical College and Hospital |
| Address |
Department of Orthopaedic Goa Medical College and hospital Bambolim Tiswadi Goa
Tiswadi Bambolim Goa
North Goa
GOA
403202
India |
| Phone |
8698074094 |
| Fax |
|
| Email |
danicadcunha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Medical College and Hospital Bambolim Tiswadi Goa |
|
|
Primary Sponsor
|
| Name |
Danica Marlyn Dcunha |
| Address |
Goa Medical College and Hospital Bambolim Tiswadi Goa |
| Type of Sponsor |
Other [Self funded ] |
|
|
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 Alisha Gracias |
Goa Medical College and Hospital |
Department of Orthopaedics Bambolim Tiswadi North Goa
North Goa
GOA |
9881887175
alisha.gracias@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants of all gender in age group 18-50 years.
Participants undergone unilateral anterior cruciate ligament reconstruction 5-8 weeks before assessment.
Participants who can read and understand the Konkani language
Participants willing to sign the informed consent.
|
|
| ExclusionCriteria |
| Details |
Revision surgery
History of previous surgery in lower extremities
Grade 3 Collateral ligament injuries, Bilateral rupture of ACL
Multiple injuries around the knee like fractures
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
estimate the presence of kinesiophobia and quality of life in participant’s who have undergone ACL
reconstruction |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
translate and estimate the psychometric properties (face validity, content validity, inter-intra rater
reliability) of Anterior Cruciate Ligament- Quality of Life (ACL-QOL) Questionnaire in Konkani |
18 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
25/05/2024 |
| 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="6"
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
|
Fear of re-injury or avoidance limits the functioning of participants undergoing ACL reconstruction. Fear also affects the quality of life of participants. The translated version of ACL-QOL questionnaire in Konkani will help the Goan participants to understand the questions in their vernicular language. There are also limited studies done to estimate the levels of kinesiophobia and quality of life in individuals following ACL reconstruction in Goa. Hence, the study will help to estimate the level of kinesiophobia and quality of life which in turn will help to address them during the rehabilitation phase to achieve better outcomes. |