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CTRI Number  CTRI/2019/03/018227 [Registered on: 22/03/2019] Trial Registered Prospectively
Last Modified On: 29/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of exercises post anterior knee ligament injury 
Scientific Title of Study   Effect of Neurocognitive rehabilitation following anterior cruciate ligament injury in potential copers: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Vinay Dole 
Designation  Master of physiotherapy(MPT) student 
Affiliation  Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore India

Bangalore
KARNATAKA
560017
India 
Phone  8411942626  
Fax    
Email  aditivdole@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Karvannan H 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  9986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Prem V 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education  
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  9886647732   
Fax    
Email  prem.v@manipal.edu  
 
Source of Monetary or Material Support  
No 98, Rustam Bagh, Old Airport road, Department of physiotjerapy, School of allied health sciences, Manipal Academy Of Higher Education, Bangalore- 560017  
 
Primary Sponsor  
Name  SOAHS Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aditi Vinay Dole  Manipal hospital  Outpatient Physiotherapy Department, Upper Basement, #98 Rustum Bagh, Old airport road, Manipal Hospital, Bangalore KARNATAKA
Bangalore
KARNATAKA 		 8411942626

aditivdole@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Conventional ACL Rehabilitation  12 weeks of supervised rehabilitation with total 30 sessions in 3 phases. Each session will last for 45-60 minutes with warm up. Early phase ( 1-4 weeks ) 3-4 sessions per week During this phase exercises such as 1) isometric and concentric strengthening of quadriceps 2) Vastus medialis obliqus activation 3) hip flexors and abductors strengthening 4) knee range of motion exercises Middle phase ( 5 - 8 weeks ) 2-3 sessions per week During this phase exercises such as 1) deep squat 2) hamstring on fit ball 3) standing vastus medialis obliqus activation 4) perturbation training on rocker board with bilateral stance 5) step up and step down Late phase ( 9 - 12 weeks ) 2-3 sessions per week During this phase functional activities on unstable surfaces such as 1) squat on BOSU ball 2) static lunge on BOSU ball 3) sideways single leg hop 4) perturbation training with unilateral stance 
Intervention  Neurocognitive Rehabilitation  12 weeks supervised rehabilitation for total 30 sessions with 3 phases. Each session will last for 45-60 minutes with warm up. Early phase ( 1 - 4 weeks) 3-4 sessions per week During this phase exercises with eyes closed such as 1)recognition of different positions on a straight line with affected leg in contact with bearing surface 2) recognition of position of knee with checkered board and execution of circular path Same as above the recognition of knee flexion-extension position by using curvilinear trajectories, sponges of different textures and oscillating table These exercises will be given along with knee exercises. Middle phase ( 5 - 8 weeks) 2-3 sessions per week During this phase exercises with eyes open such as 1) In squat, lunge, side lunge positions - perform the different trajectories, various circles with affected limb, both up-hill and down-hill 2) On moving oscillating table planned transfer of load - front to back and back to front 3) On oscillating table load transfer with affected leg while the unaffected leg on the stepper. These exercises will be given along with knee exercises. Late phase ( 9 - 12 weeks) 2-3 sessions per week During this phase functional activities with external focus such as 1) single leg hop with air target, unstable landing, reaction ball 2) broad jump with reaction ball and on anticipated cut 3) single leg air target reaction ball These exercises will be given along with the knee exercises. Intervention group will receive exercises with the same duration as conventional ACL rehabilitation group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Individuals diagnosed with ACL injury with following criteria for potential copers:
1.Self reported episode of knee giving way 1 or less
2.Single-leg 6-meter timed hop index 80% or greater
3.Knee Outcome Survey activities of daily living subscale 80% or greater
4.Global rating score 60% or greater
5.80% or greater quadriceps strength

 
 
ExclusionCriteria 
Details  • Any associated knee injury like meniscal tear, patellar tendonitis, Patlleofemoral pain syndrome, inflammatory knee diseases.
• Associated fracture of lower limb
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Knee outcome survey- activities of daily living subscale (KOS ADL)
2.Two point discrimination using vernier caliper 		 Pre intervention, at the end of 6th week, at the end of 12th week by blinder 
 
Secondary Outcome  
Outcome  TimePoints 
1.Single leg 6m timed hop index
2.Global rating score
3.Numerical pain rating scale
4.Knee proproception using inclinometer
5.Quadriceps strength using hand held dynamometer
6.Range of motion using standard long arm goniometer
 		 Pre intervention, at the end of 6th week, at the end of 12th week by blinder 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/04/2019 
Date of Study Completion (India) 07/03/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Following anterior cruciate ligament injury cascade of neuroplastic changes occur which affect the outcome post injury.. Available treatment approaches emphasis on biomechanical factors like muscle strength, flexibility, and plyometric function and give less consideration to cognitive or neurological components.  The training & restoration of primarily biomechanical factors may not address all the physiologic consequences of in­jury, as patient-reported dysfunction and poor movement control may persist for years.

             Till date, no studies could  be retrieved the knee function, injury recov­ery and re-injury prevention  following ACL injury in copers. Hence the study focuses on effect of neurocognitive rehabilitation on knee function following ACL injury in copers.

 
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