| CTRI Number |
CTRI/2025/06/088677 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
"Do physiotherapy guidelines match with what young athletes who play sports for fun expect during their Anterior cruciate ligament recovery process? – A study based on their personal experiences and opinions |
|
Scientific Title of Study
|
Exploring the alignment between Physiotherapy clinical practice guidelines and young recreational athletes’ expectations regarding Anterior cruciate ligament rehabilitation - A Qualitative 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 |
Tanaya Ganesh Hadawale |
| 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, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8655656533 |
| Fax |
|
| Email |
hadawale.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr 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, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8971984556 |
| Fax |
|
| Email |
prateek.srivastav@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika Jadhav |
| Designation |
Assistant professor |
| 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, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
7829500469 |
| Fax |
|
| Email |
radhika.aj@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room no.215, Department of Physiotherapy, Second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal- 576104, Udupi, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Tanaya Ganesh Hadawale |
| 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, India |
| Type of Sponsor |
Other [Self sponsor] |
|
|
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 |
| Tanaya Ganesh Hadawale |
Kasturba Hospital, Manipal |
Room no.101,N1,Department of Physiotherapy, Physiotherapy OPD, Baliga block, Kasturba Hospital, Manipal-576104, Udupi, Karnataka
Udupi
KARNATAKA |
8655656533
hadawale.mchpmpl2024@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M798||Other specified soft tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 18 to 30 years
Both sexes
Young recreational athletes with first ACL
injury along with associated knee injuries (Meniscal injury, Collateral ligament injury, Bony injury and Cartilage injury) either surgically or conservatively managed.
Individuals who can communicate only in English
|
|
| ExclusionCriteria |
| Details |
Individuals who cannot communicate in English
Individuals with any neurological impairment
that might affect the recovery.
Individuals with any previous lower limb
injuries managed with physiotherapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expectations of young recreational athletes regarding Anterior cruciate ligament rehabilitation |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Alignment between Physiotherapy clinical practice guidelines & young recreational athletes expectations regarding Anterior cruciate ligament rehabilitation |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "11"
Final Enrollment numbers achieved (India)="11" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/09/2025 |
| Date of Study Completion (India) |
20/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/03/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
This will be an observational study conducted to explore whether Physiotherapy clinical practice guidelines align with young recreational athletes’ expectations regarding Anterior cruciate ligament rehabilitation. A qualitative study will be conducted where we will be taking face-to-face semi- structured interview of the participants knowing their expectations regarding Anterior cruciate ligament rehabilitation and exploring whether they align with the Physiotherapy clinical practice guidelines. Participants will be screened as per inclusion and exclusion criteria. Participation information sheet will be provided and Informed consent will be obtained from the participants. Privacy will be ensured throughout the conduct of the interview. Face to face interviews will be conducted in a quiet room in English language based on interview guide and audio recording will be done using a smart phone. Field notes will be taken during the interview. Data will be collected until data saturation and collected data will then be transcribed and analysed using thematic analysis approach. Themes generated at the end of the study will be used to explore whether they align with Physiotherapy clinical practice guidelines of ACL injury. |