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CTRI Number  CTRI/2024/01/061488 [Registered on: 15/01/2024] Trial Registered Prospectively
Last Modified On: 05/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two types of exercises, one in which muscle length increases and the other in which the muscle length decreases in persons who have undergone surgical repair of Knee ligament.  
Scientific Title of Study   Eccentric versus Concentric exercises for Quadriceps strengthening in persons who have undergone anterior cruciate ligament reconstruction –Single blinded Randomized Control Trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Merlyn R 
Designation  Associate Professor 
Affiliation  Christian Medical College, Vellore 
Address  Room No.8, Physiotherapy Unit, PMR department. Christian Medical College, Vellore, - 632 004

Vellore
TAMIL NADU
632004
India 
Phone  09444463948  
Fax  04162282035  
Email  merlyntilak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Merlyn R 
Designation  Associate Professor 
Affiliation  Christian Medical College, Vellore 
Address  Room No.8, Physiotherapy Unit, PMR department. Christian Medical College, Vellore, - 632 004

Vellore
TAMIL NADU
632004
India 
Phone  09444463948  
Fax  04162282035  
Email  merlyntilak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Merlyn R 
Designation  Associate Professor 
Affiliation  Christian Medical College, Vellore 
Address  Room No.8, Physiotherapy Unit, PMR department. Christian Medical College, Vellore, - 632 004

Vellore
TAMIL NADU
632004
India 
Phone  09444463948  
Fax  04162282035  
Email  merlyntilak@gmail.com  
 
Source of Monetary or Material Support  
Internal fluid research grant Office of Research, 1st Floor, Carman Block, Bagayam, Vellore 632 002, India. E-mail: research@cmcvellore.ac.in. Tel: 0416 -2284294, Fax: 0416 – 2262788  
 
Primary Sponsor  
Name  Internal fluid research grant 
Address  Institutional Review Board, Christian Medical College, Vellore- 632002  
Type of Sponsor  Private medical college 
 
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 
Dr Merlyn R  Christian Medical College, Vellore.  Room No.8, Physiotherapy Unit, PMR department. Christian Medical College, Vellore, - 632 004
Vellore
TAMIL NADU 
09444463948
04162282035
merlyntilak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Concentric exercises   In high sitting position, lift the leg from flexion to straight knee position and hold for 5 secs in that position before bringing it to the starting position. Repeat this for 10 repetitions, 3 sets, 5 times a day.  
Intervention  Eccentric exercises   In high sitting position, gently bend the leg from straightened knee to flexion. Repeat this for 10 repetitions, 3 sets, 5 times a day.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Moderately active before the injury
2. Concurrent injury to the MCL, Meniscectomy 
 
ExclusionCriteria 
Details  1. Previous fracture or reconstruction surgery in the lower limb
2. surgery of both the limbs revision surgery, inflammatory disease and other articular disease.
3. Concurrent injury to the PCL, LCL 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Muscle Strength: Modified Oxford Scale  1. At Baseline
2. Post-op day 3
3. 2 weeks Post-op
4. 6 months follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
a) Muscle Bulk: Using inch tape the measurement is taken 15 cm proximal to the
superior pole of the patella.
b) Quadriceps Hamstrings Index: using Dynamometer
c) Active Knee Range of Motion: Using Goniometer
d) Knee Pain: Using Visual Analog Scale.
e) Electrical muscle activity- EMG surface electrodes
f) Functional activities: Using Lysholm score, 6m hop test
 
1. At Baseline
2. Post-op day 3
3. 2 weeks Post-op
4. 6 months follow-up 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3 
Date of First Enrollment (India)   22/01/2024 
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="2"
Months="6"
Days="25" 
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 - NO
Brief Summary  
Persons with anterior cruciate ligament injury (ACL) for whom all inside technique ACLR is
planned under Ortho III unit, will be assessed for eligibility and will be included after a
written consent by the Principal investigator. Pre-operative assessment will be done, which
will include assessment of muscle girth using inch tape, muscle strength using Modified
Oxford scale, pain using Visual Analogue Scale (VAS score), active ROM using Goniometer,
Quadriceps Hamstring Index (Q/H index), electrical muscle activity of the hamstring muscle
using surface EMG electrodes and Functional activities using 3 meter hop test, and Lysholm
score. After the initial assessment the subjects will be given a short-term prehab which will
include knee strengthening and range of motion exercises, to continue till the day of surgery
and the rehabilitation protocol will be explained. (APPENDIX -1) To ensure homogeneity,
subjects who have undergone surgery by the same Orthopedic surgeon(Co-investigator) and
his team will be recruited. Following surgery, supervised physiotherapy will be given and all
the patients will be following the rehabilitation protocol from post-operative day 1(POD 1).

On POD 3, assessment of pain, muscle strength and active knee ROM will be done.
Computer generated randomization will be done; sequentially numbered, opaque sealed
envelopes (SNOSE) will be used for allocation concealment and the subjects will be
randomly allocated to one of the two groups from POD 3. Group I will receive eccentric
exercises and Group II will receive concentric exercises for quadriceps strengthening for 2
weeks. In addition, both these groups will be following the exercises of Phase I of the
rehabilitation protocol (Phase I: Immediate Post-operative period, 1 to 2 WEEKS). At the end
of 2nd week reassessment of pain, muscle girth, muscle strength, active ROM and function
will be done.
The subjects will be advised to continue the rehabilitation protocol at home. A follow- up
assessment will be done at 6 months which will include VAS score, Muscle strength,
including Quadriceps Hamstring Index (Q/H index), electrical muscle activity of the
hamstring muscle, muscle girth, knee range of motion and knee function. All evaluations will
be done by a blinded observer. Analysis will be done to find out the effect of Eccentric
exercises versus Concentric exercises in subjects who have undergone ACL Reconstruction.
 
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