| CTRI Number |
CTRI/2024/06/068902 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Examining lower limb strength and balance in individuals with knee soft tissue injuries |
|
Scientific Title of Study
|
Lower extremity limb symmetry index in individuals with knee soft tissue 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 |
Adithi S Bhaktha |
| Designation |
Post graduate student |
| Affiliation |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University) |
| Address |
Department of physiotherapy, Room number 20, second base division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9380832894 |
| Fax |
|
| Email |
adithibhaktha7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saumya Srivastava |
| Designation |
Associate Professor |
| Affiliation |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University) |
| Address |
Department of physiotherapy, Room number 20, second base division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9740244077 |
| Fax |
|
| Email |
saumyasri2000@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Adithi S Bhaktha |
| Designation |
Post graduate student |
| Affiliation |
Nitte institute of physiotherapy, NITTE (Deemed to be University) |
| Address |
Department of physiotherapy, Room number 20, second base division, Nitte institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9380832894 |
| Fax |
|
| Email |
adithibhaktha7@gmail.com |
|
|
Source of Monetary or Material Support
|
| NITTE Institute of Physiotherapy, NITTE (Deemed to be university) will provide the basic infrastructure facility, no other monitory support is required |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy, (NITTE Deemed to be University) |
| Address |
Department of physiotherapy, Room number 20, second base division, NITTE institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, 575018 |
| Type of Sponsor |
Other [Constituent colleges of Nitte Institute of Physiotherapy, NITTE (Deemed to be University)] |
|
|
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 Saumya Srivastava |
Justice K S Hegde Charitable Hospital |
Department of physiotherapy, Room number 20, second base division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA |
9740244077
saumyasri2000@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Nitte Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S809||Unspecified superficial injury ofknee and lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Individual with a history of meniscal and ACL injuries (1-5 years)
2. Grade 1 injuries
3. Conservatively managed meniscal and ACL injuries
4. BMI within the normal range – 18.5 - 24.9 kg/m2
5. Unilateral history of meniscal and ACL injury
6. Foot posture index score (-1 to 6)
7. Individuals able to hold static quadriceps for 30 seconds in supine
|
|
| ExclusionCriteria |
| Details |
1. Post surgical lower extremity fracture or surgery
2. Knee pain
3. Neurological conditions
4. Swelling around the knee joint
5. Ankle instability |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Limb Symmetry Index |
Limb Symmetry Index will be done once at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
05/02/2025 |
| 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
Modification(s)
|
Knee injuries are
prevalent among active individuals and can lead to long-term functional
limitations, affecting mobility, performance, and quality of life. (3) Accurate
assessment tools are essential for guiding rehabilitation and return-to-sport
decisions. The Limb Symmetry Index (LSI) is a widely used measure in evaluating
functional recovery, yet there is a lack of comprehensive research on its
application using hop tests in individuals with conservatively managed knee
soft tissue injuries.
Current rehabilitation
programs often rely on subjective assessments, leading to inconsistencies in
clinical decision-making. Objective functional testing using LSI through hop
tests can provide a standardized approach to quantify lower limb recovery, ensuring
accurate comparisons between the injured and uninjured limb. This study is
essential in bridging the gap in the literature by providing evidence-based
data on LSI, which can improve clinical protocols, optimize rehabilitation
strategies, and minimize the risk of reinjury.(14)
Furthermore, establishing
LSI as a validated parameter in musculoskeletal rehabilitation will contribute
to developing personalized treatment plans, enhancing patient outcomes, and
reinforcing evidence-based practices in sports physiotherapy. The study’s
findings will aid clinicians in setting precise rehabilitation benchmarks,
ultimately facilitating a safe and effective return to activity for individuals
recovering from knee soft tissue injuries.
|