| CTRI Number |
CTRI/2024/05/066678 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study which identifies fear of movement in male and female athletes after leg injuries |
|
Scientific Title of Study
|
Sex differences in Kinesiophobia among athletes following lower limb injuries: 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 |
Shivani Parikh |
| Designation |
MPT Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no.215
Department of Physiotherapy
Second floor,
Manipal College of Health Professions
Manipal Academy of Higher Education
Madhav Nagar
Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9619523042 |
| Fax |
|
| Email |
shivani2.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Prateek Srivastav |
| Designation |
Assistant Professor selection grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no.215
Department of Physiotherapy
Second floor,
Manipal College of Health Professions
Manipal Academy of Higher Education
Madhav Nagar
Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8971984556 |
| Fax |
|
| Email |
prateek.srivastav@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Parikh |
| Designation |
MPT Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no.215
Department of Physiotherapy
Second floor,
Manipal College of Health Professions
Manipal Academy of Higher Education
Madhav Nagar
Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9619523042 |
| Fax |
|
| Email |
shivani2.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy
Manipal College of heath professions
Manipal Academy of Higher Education
Manipal-576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Department of physiotherapy
Manipal College of heath professions
Manipal Academy of Higher Education
Manipal-576104
|
| Type of Sponsor |
Contract research organization |
|
|
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 Prateek Srivastav |
Kasturba Hospital |
Room 215, Department of Physiotherapy,
Outpatient Department,
First floor
Baliga Block,
Kasturba Hospital,
Madhav nagar,
Udupi-Hebri Road,
Manipal-576104
Udupi
KARNATAKA |
8971984556
prateek.srivastav@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 |
| Healthy Human Volunteers |
Athletes who have experienced lower limb injuries in the past 1 year |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participant playing any sports for last 1 year for at least 2-3 days/week
Any lower limb injury |
|
| ExclusionCriteria |
| Details |
History of any systemic disease
Neurological condition
Congenital condition of lower limb
Diagnosed psychiatric condition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kinesiophobia is measured using Fear Avoidance Components Scale |
only once as a baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2024 |
| Date of Study Completion (India) |
09/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Kinesiophobia may
be influenced by various factors. Studies have shown sex differences in kinesiophobia in patients with
musculoskeletal conditions but not much have been explored in athletes with lower limb injuries.
However, the lack of research in the influence of sex on kinesiophobia paves the way to further
investigation of this factor in athletes with lower limb injuries, the understanding of which will help to
enhance the evaluation of the athletes. If kinesiophobia is not treated in conjunction with other aspects
of rehabilitation, athletes with lower limb injuries may be more likely to re-injure, perform less well
physically, and experience increased psychological disturbances. Therefore, there is a need to explore
sex differences in kinesiophobia in athletes with lower limb injuries Athletes will be recruited using advertisement brochures. Permission will be taken from the physical
education department of each college. Written informed consent will be taken from the participant. The
procedure and the need of the study will be explained to each participant. The participant will ask about
basic details like name, contact number, age, gender, weight, type of sport, duration of play and pain
history. The participant will be asked to fill the questionnaire which contains 20 questions with a six point scale ranging from completely agree to completely disagree. The investigator will solve the doubts,
if any, regarding the questionnaire and the study. Pen and the form will be provided for the same. Total
time required will be 10 mins. It is a one-time visit study. Refreshments will be provided to the participant. |