| CTRI Number |
CTRI/2026/02/102944 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of a Physiotherapy Rehabilitation Program on Knee Movement Control in People After ACL Knee Ligament Surgery |
|
Scientific Title of Study
|
Development, Validation And Comparative Effectiveness Of A Consensus-Driven Rehabilitation Protocol For Optimizing Tibial Rotation Control In Individuals Following Anterior Cruciate Ligament Reconstruction With Semitendinosus And Gracilis Graft |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abba Sanketh |
| Designation |
PhD Research Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no.8, Department of Arthroscopy and Sports Medicine, G block, Sri Ramachandra Hospital, Sri Ramachandra Institute of Higher Education and Research, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9177745764 |
| Fax |
|
| Email |
sankethabba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JIBU GEORGE VARGHESE |
| Designation |
Professor and Principal |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no.2, 2nd floor, Sri Ramachandra Center for Sports Science, Sri Ramachandra Faculty of Sports and Exercise Sciences, Sri Ramachandra Institute of Higher Education and Research, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9841199942 |
| Fax |
|
| Email |
jibugeorgevarghese@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Abba Sanketh |
| Designation |
PhD Research Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no.8, Department of Arthroscopy and Sports Medicine, G block, Sri Ramachandra Hospital, Sri Ramachandra Institute of Higher Education and Research, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9177745764 |
| Fax |
|
| Email |
sankethabba@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Abba Sanketh |
| Address |
Sri Ramachandra Faculty Of Sports And Exercise Sciences,
Sri Ramachandra Institute Of Higher Education And Research
Porur
Chennai
Tamil Nadu
India
600116 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Abba Sanketh |
Sri Ramachandra Hospital |
Room No 8
Department Of Arthroscopy And Sports Medicine
G Block
Sri Ramachandra Institute Of Higher Education And Research
Porur
Chennai
Chennai
TAMIL NADU |
9177745764
sankethabba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Consensus Driven Criterion Based Physiotherapy Rehabilitation Protocol |
A structured and customized physiotherapy rehabilitation program designed to improve knee rotation control following anterior cruciate ligament reconstruction. The protocol includes targeted medial hamstring strengthening neuromuscular control training kinetic chain integration exercises and balance training with criterion based progression. The intervention is delivered under supervision for a total duration of twelve weeks in addition to routine postoperative care. |
| Comparator Agent |
Standard Institutional Physiotherapy Rehabilitation Protocol After Anterior Cruciate Ligament Reconstruction |
A conventional postoperative physiotherapy rehabilitation program routinely followed after anterior cruciate ligament reconstruction. The protocol focuses on restoration of range of motion muscle strengthening functional training and gradual return to activity without specific emphasis on knee rotation control. The rehabilitation is supervised and delivered for a total duration of twelve weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Male adults aged eighteen to forty five years.
Participants who have undergone unilateral primary anterior cruciate ligament reconstruction using semitendinosus and gracilis autografts for isolated anterior cruciate ligament injury only without any concomitant meniscal procedures.
Medical clearance from the treating arthroscopic surgeon for full participation in rehabilitation and training.
No previous history of knee or foot surgery.
Participants who are able to understand and read English independently for completing questionnaires administered in English.
Participants who provide written informed consent and are willing to comply with follow up assessments and the full duration of the intervention. |
|
| ExclusionCriteria |
| Details |
Any concomitant meniscal injury requiring surgical intervention including repair resection or balancing.
Primary anterior cruciate ligament reconstruction performed using peroneal graft or bone patellar tendon bone graft.
Revision anterior cruciate ligament reconstruction or presence of excessive chondral damage.
Multi ligament knee injuries involving medial collateral ligament lateral collateral ligament posterior cruciate ligament or anterolateral ligament or associated rotatory instability patterns requiring additional ligament reconstruction.
History of significant injury to the contralateral lower limb.
Body mass index more than thirty five.
Presence of significant knee osteoarthritis defined as Kellgren Lawrence grade more than two.
Presence of neuromuscular disorders affecting lower limb function.
Pre existing flatfoot or flexible pes planus defined by a navicular drop more than ten millimeters.
Contraindications to testing or exercise including acute infection.
Generalized ligamentous laxity defined as Beighton score five or more out of nine.
Presence of congenital or acquired lower leg deformities other than tibial rotation.
Leg length discrepancy more than two centimeters. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Internal tibial rotation range of motion measured using the thigh foot angle method with a universal goniometer. |
baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Medial to lateral hamstring muscle strength ratio assessed using a handheld dynamometer. |
baseline & 12 weeks |
| International Knee Documentation Committee subjective knee score |
Baseline, 6 weeks & 12 weeks |
| Hamstring to quadriceps muscle strength ratio assessed using a handheld dynamometer. |
Baseline & 12 weeks |
| Hip abductor muscle strength assessed using a handheld dynamometer. |
Baseline, 6 weeks & 12 weeks |
| Navicular height & navicular drop measurement to assess foot arch mechanics. |
Baseline, 6 weeks & 12 weeks |
| Dynamic balance & neuromuscular control assessed using the Y Balance Test lower quarter. |
6 weeks & 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
01/07/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - De identified individual participant data will be shared upon reasonable request. Requests should be directed to the corresponding author through email. Access will be granted after review of the proposal for scientific merit and ethical compliance. Approved requestors will be required to sign a data access agreement before data sharing.
- For how long will this data be available start date provided 01-03-2028 and end date provided 28-02-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to develop and evaluate a structured physiotherapy rehabilitation program designed to improve knee rotation control following anterior cruciate ligament reconstruction. Participants who have undergone unilateral primary anterior cruciate ligament reconstruction using semitendinosus and gracilis autografts will be randomly allocated to receive either a consensus driven criterion based rehabilitation protocol or a standard institutional rehabilitation protocol. The primary purpose of the study is to compare the effectiveness of the two rehabilitation approaches on internal tibial rotation range of motion and medial to lateral hamstring muscle strength balance over a twelve week intervention period. The study hypothesizes that the structured consensus driven rehabilitation protocol will result in greater improvement in knee rotation control and muscle balance compared to the standard rehabilitation protocol. Outcome assessments will be performed by a blinded assessor at baseline and at predefined follow up time points. |