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CTRI Number  CTRI/2024/11/076301 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized Factorial Trial 
Public Title of Study   Effect of conventional rehabilitation with muscle energy technique versus conventional rehabilitation with continuous passive motion on knee joint functions in subjects with ACL reconstruction. 
Scientific Title of Study   Effect of conventional rehabilitation with muscle energy technique versus conventional rehabilitation with continuous passive motion on knee joint functions in subjects with ACL reconstruction 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Umiya I Pathan 
Designation  Professor 
Affiliation  D. Y. Patil University, Kolhapur 
Address  D. Y. Patil College Of Physiotherapy, Kolhapur Department :Musculoskeletal Physiotherapy department Division: Head of department of musculoskeletal physiotherapy. Roll no. 4

Kolhapur
MAHARASHTRA
416003
India 
Phone  9922971981  
Fax    
Email  drumiyapathan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Umiya I Pathan 
Designation  Professor 
Affiliation  D. Y. Patil University, Kolhapur 
Address  D. Y. Patil College Of Physiotherapy, Kolhapur Department :Musculoskeletal Physiotherapy department Division: Head of department of musculoskeletal physiotherapy. Roll no. 4

Kolhapur
MAHARASHTRA
416003
India 
Phone  9922971981  
Fax    
Email  drumiyapathan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Umiya I Pathan 
Designation  Professor 
Affiliation  D. Y. Patil University, Kolhapur 
Address  D. Y. Patil College Of Physiotherapy, Kolhapur Department :Musculoskeletal Physiotherapy department Division: Head of department of musculoskeletal physiotherapy. Roll no. 4

Kolhapur
MAHARASHTRA
416003
India 
Phone  9922971981  
Fax    
Email  drumiyapathan@gmail.com  
 
Source of Monetary or Material Support  
D. Y. Patil Hospital, Kolhapur  
 
Primary Sponsor  
Name  D Y Patil Hospital Kolhapur 
Address  D. Y. Patil Hospital, sonal colony , scheme no. 4,laxminarayan nagar, kolhapur  
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 
Dr Umiya Pathan  D. Y. Patil Hospital, Kolhapur  Address: sonal colony , scheme no. 4,laxminarayan nagar, kolhapur Department :Musculoskeletal Physiotherapy department Division: Head of department of musculoskeletal physiotherapy. Roll no. 4
Kolhapur
MAHARASHTRA 		 09922971981

drumiyapathan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee D. Y. Patil Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Effect of conventional rehabilitation with muscle energy technique versus conventional rehabilitation with continuous passive motion on knee joint functions in subjects with ACL reconstruction.  Participants will be then randomly divided into three groups by simple random method ( chit method ) Week wise interventions are as follows WEEK 1: Group A ( Conventional group) : -Static exercise- holding quadriceps muscle contractions for 30 seconds and repeating 10 times. Knee ROM exercises- Flexion, extension repeating for 10 times Passive hamstring stretching exercises- hip will be flexed knee will be extended , hold the position for 30 sec then repeat for 3 times Group B (Conventional group with Muscle Energy Technique):- Conventional rehabilitation + Muscle Energy Technique- leg is flexed from hip and knee. then knee is straightened until barrier , isometric contraction of hamstring will be performed against resistance For 20 min Group C ( Conventional group with CPM :- Conventional rehabilitation + CPM For 20 min WEEK 2- for all group same like WEEK 1 WEEK 3 - Group A ( Conventional group):- Same as week 1 and Static exercise for Hamstring-Holding hamstring muscle contractions for 30 seconds and repeating 10 times. Knee ROM exercises- Flexion, extension repeating for 10 times Passive quadricep stretching exercise- knee will be flexed and hold it for 30 sec. then repeat for 3 times Group B (Conventional group with Muscle Energy Technique:- Same as week 1 and Static exercises Knee ROM exercises Muscle Energy Technique leg is flexed from hip and knee. then knee is straightened until barrier , isometric contraction of agonist of hamstring ( quadriceps) will be performed against resistance Group C ( Conventional group with CPM :- Same as week 1 and Static exercises Knee ROM exercises CPM WEEK 4- For all group same like WEEK 3 
Intervention  Effect of conventional rehabilitation with muscle energy technique versus conventional rehabilitation with continuous passive motion on knee joint functions in subjects with ACL reconstruction.  Same as week 1 and Static exercise for Hamstring-Holding hamstring muscle contractions for 30 seconds and repeating 10 times. Knee ROM exercises- Flexion, extension repeating for 10 times Passive quadricep stretching exercise- knee will be flexed and hold it for 30 sec. then repeat for 3 times Group B (Conventional group with Muscle Energy Technique:- Same as week 1 and Static exercises Knee ROM exercises Muscle Energy Technique leg is flexed from hip and knee. then knee is straightened until barrier , isometric contraction of agonist of hamstring ( quadriceps) will be performed against resistance Group C ( Conventional group with CPM :- Same as week 1 and Static exercises Knee ROM exercises CPM WEEK 4- For all group same like WEEK 3 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Subjects undergone ACL Reconstruction with patellar tendon graft PTB
2. Subjects with moderate or severe pain on NPRS scale
3. Subjects with reduced range of knee flexion more than 90 degree
4. Subjects with hamstring muscle tightness AKE test 115 to 140 degree
5. Participants willing to give consent
 
 
ExclusionCriteria 
Details  1. Fractures or healing fracture of long bones to Femur, Tibia, Fibula and Patella
2. Subjects with bone pathologies like Osteomyelitis, osteoporosis, bone tumors
3. Uncooperative psychiatric patients
4. Preexisting neuromuscular disorders
5. Subjects underwent revision surgeries
6. Patients who are not following exercises
7. Patients who have surgery/fall to the affected limb during rehabilitation

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Pain will be assisted by Numerical pain rating scale
2.Range of motion will be assisted by Active Knee extension test
3.Hamstring muscle tightness will be assisted Modified sit and reach test
 		 at the 1st enrollment and at the 4th week  
 
Secondary Outcome  
Outcome  TimePoints 
3.Hamstring muscle tightness will be assisted Modified sit & reach test
 		 Two years  
 
Target Sample Size   Total Sample Size="107"
Sample Size from India="107" 
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)   05/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/11/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   The above study shows a comparison between muscle energy technique and continuous passive motion in patients whose ACL tendon is repaired by using a bone tendon bone graft by assessing pain ( NPRS Scale), Range of Motion ( Active Knee extension Test) and hamstring muscle tightness (Modified sit and reach test) 
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