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CTRI Number  CTRI/2020/11/028949 [Registered on: 06/11/2020] Trial Registered Prospectively
Last Modified On: 18/12/2021
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   A clinical trial to study the effect of Progressive Neuromuscular Training exercise on pain, function and balance in subjects with Knee Osteoarthritis. 
Scientific Title of Study   Effects of Progressive Neuromuscular Training on Pain, Function and Balance in patients with Knee Osteoarthritis: A Randomized Control Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sajiri Joshi 
Designation  Student - MPT I 
Affiliation  Sancheti Institute College of Physiotherapy  
Address  Sancheti Institute College of Physiotherapy,12 Thube Park Shivajinagar Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  9657002386  
Fax    
Email  sajirijoshi9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sona Kolke 
Designation  Associate Professor, Department of Musculoskeletal Physiotherapy 
Affiliation  Sancheti Institute College of Physiotherapy  
Address  Sancheti Institute College of Physiotherapy,12 Thube Park Shivajinagar Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  9371004121  
Fax    
Email  sona.sarma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sajiri Joshi 
Designation  Student - MPT I 
Affiliation  Sancheti Institute College of Physiotherapy  
Address  Sancheti Institute College of Physiotherapy,12 Thube Park Shivajinagar Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  9657002386  
Fax    
Email  sajirijoshi9@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Institute College of Physiotherapy 
 
Primary Sponsor  
Name  Sancheti Institute College of Physiotherapy  
Address  Sancheti Institute College of Physiotherapy, 12 Thube Park Shivajinagar Pune 411005 
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 
Sajiri Joshi  Sancheti Institute College of Physiotherapy  Sancheti Institute College of Physiotherapy,Physiotherapy Department, Musculoskeletal Physiotherapy Divison ,12 Thube Park Shivajinagar Pune 411005
Pune
MAHARASHTRA 		 9657002386

sajirijoshi9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sancheti Institute for Orthopedics and Rehabilitation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Exercises of Knee Osteoarthritis  2 days/week for 6 weeks 
Intervention  Neuromuscular Training   2 days/week, for 6 weeks  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Grade II and III on Kellgeren Lawrence Scale
2)American Rheumatism Association Classification of Knee Osteoarthritis
3)NPRS > 2.5 – 5
 
 
ExclusionCriteria 
Details  1)Post-surgical knee, knee or hip replacement, tibial osteotomy
2)Systemic arthritis
3)Any other condition having effect on lower limb function
4)History of cardio-vascular disease or peripheral-vascular disease, uncontrolled hypertension with restriction of physical activity.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain and Function  Pre and Post Intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Balance  Pre and Post Intervention 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2020 
Date of Study Completion (India) 16/09/2021 
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
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This was a Randomized, Double-blinded, Active control, Parallel group trial that studies the effects of Progressive Neuromuscular Training on Pain, Function, and Balance in Patients with Knee Osteoarthritis. 62 subjects were randomly allocated into two groups. The intervention group received Progressive Neuromuscular Training exercise,  and the control group performed strengthening exercises Both the groups performed exercises for 60 minutes per session, twice a week for 6 weeks. The outcome measures Pain (Visual Analogue Scale), Function (Patient Specific Function Scale, Timed Up and Go test, Sit to Stand Test, Stair Climb Test), Balance (Y - balance Test) were assessed before and after 6 weeks of intervention. Out of 160 subjects that were screened for eligibility 98 were excluded as 94 did not meet the inclusion criteria (32 subjects were KL grade 1 OA, 40 were KL grade 4 OA, 7 subjects had systemic arthritis and 15 had associated back pain) and 4 declined to participate. 62 subjects were included in the study and were randomly allocated into two groups viz. Group A (NMT) and Group B (Strength training). 8 subjects were lost to follow-up - 2 withdrew due to unrelated health reasons, 4 failed to comply, and 2 had injuries unrelated to the intervention. Data of 54 subjects who completed the intervention (Group A = 28) and Group B (n=26) was analyzed using SPSS version 26 (IBM Chicago)with an alpha level set at 0.05. Baseline data were analyzed to determine whether both groups were matched at preintervention using an unpaired t-test ( Y balance, TUG)  and Mann- Whitney U test (NPRS, WOMAC, PSFS, Chair-stand test, Stair climb test). Except for TUG scores, all outcome measures matched the baseline. Within-group differences for both the groups were analyzed using Wilcoxon- signed-rank test (Non - parametric data - NPRS, chair stand test, stair climb test, PSFS, and WOMAC) and paired t-test (parametric data - Y -  balance test). Between-group differences were analyzed using an unpaired t-test ( Y balance, TUG)  and Mann- Whitney U test (NPRS, WOMAC, PSFS, Chair-stand test, Stair climb test). Results of within-group comparisons displayed significant improvements in both groups for all measured variables whereas between-group comparisons were significantly greater in the NMT group in reducing pain (NPRS), improvement in function(PSFS, WOMAC, Chair-stand test, TUG), and balance when compared to controls. 


 
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