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CTRI Number  CTRI/2018/03/012399 [Registered on: 07/03/2018] Trial Registered Retrospectively
Last Modified On: 23/04/2019
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   Effects of Whole Body Vibration and Wobble board Exercises in Knee osteoarhritis. 
Scientific Title of Study   Comparison of muscle strength, physical function, QOL and balance between whole body vibration versus wobble board exercises in knee osteoarthritis patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Zubia Veqar 
Designation  Assistant professor  
Affiliation  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia 
Address  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  veqar.zubia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Zubia Veqar 
Designation  Assistant professor  
Affiliation  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia 
Address  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  veqar.zubia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Tahseen Anjum 
Designation  Student 
Affiliation  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia 
Address  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  tahsen92@gmail.com  
 
Source of Monetary or Material Support  
Jamia Millia Islamia(central university), Maulana Md Ali Jauhar Marg, Okhla, NDelhi. India 
 
Primary Sponsor  
Name  Jamia Millia Islamia 
Address  OKHLA 
Type of Sponsor  Other [Central university] 
 
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 Zubia Veqar  Jamia Millia Islamia  Room no 204, Centre For Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia,Maulana Md Ali Jauhar Marg, Okhla, NEW DELHI, DELHI-110025
South
DELHI 
9958993486

veqar.zubia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, JAMIA MILLIA ISLAMIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Physiotherapy  Whole body vibration therapy The intervention will be given four times a week for four weeks Patients will stand on whole body vibrator platform which will oscillates at a frequency of 25-30 Hz and amplitude of 5mm (6 training cycles of 3 minutes) For each treatment session, participants will stand on the vibration platform with their knees bent 20 degree to the vertical with 30 seconds rest between bouts in addition with conventional therapy which includes knee isometric exercises (6-second contractions with 8 repetitions and a rest period of 2 seconds), walking and lifestyle modification. 
Comparator Agent  Physiotherapy  Wobble board exercises The intervention will be given four times a week for four weeks. All the patients of this group will perform wobble board exercises standing with 2 legs, eyes open/close multidirectional, standing with one leg, eyes open/close, unidirectional, standing with one leg, eyes open/close, multidimensional, in addition with conventional therapy which includes knee isometric exercises (6-second contractions with 8 repetitions and a rest period of 2 seconds), walking and lifestyle modification.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Aged 40-65 years.
1.Knee osteoarthritis based on clinical and radiographic criteria of ACR (Mild-Moderate).
2.BMI ≥ 25kg/m².
3.NPRS 2-6.
4.Able to maintain balance on unipedal stance test with eyes open and closed.
5.Normal hearing and normal or corrected to normal vision.
6.Working knowledge of English language. 
 
ExclusionCriteria 
Details  1. Any other associated back, Ankle, hip or foot disorders.
2. Any other associated neurological or cardiorespiratory disorder which will interfere with the treatment programme.
3. Any recent trauma or surgery, Recently fitted IUDs
4. Cancer.
5. Individuals who received any intra-articular injections to treat OA within 4 weeks before the study.
6. Inability to understand the procedure.
7. Use of centrally active medications. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain using NPRS
Surface EMG of Quadriceps and Hamstring Group of muscles
Y-balance test 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Physical function
Quality of life 
4 weeks 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2018 
Date of Study Completion (India) 30/04/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/04/2018 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction: Knee osteoarthritis (OA) is one of the most common forms of degenerative joint disease affecting both males and females. Knee OA is characterized by symptoms which include pain, joint stiffness and reduced quadriceps strength, causing physical disability.   Individuals with knee OA suffer progressive loss of function, displaying increasing dependency in walking, stair climbing and other lower extremity tasks. Intact and optimal neuromuscular function is supposed to be of critical importance to development and/or progression of knee OA. Balance is a significant component of many essential activities of daily living. Effective control of balance thus relies not only on accurate sensory input but also on a timely response of strong muscles. Strength of the quadriceps muscles is an important intrinsic factor for check knee joint function. Recently, the use of whole body vibration (WBV) for increasing muscle strength in individuals with knee OA has been advocated as an efficient and alternative method to resistance training.

 Objectives of the study: To compare the effects of wobble board exercises and whole body vibration therapy exercise on pain, muscle strength, physical function, QoL and balance in knee osteoarthritis patients.

 Significance of the study: This study will have implications for Physiotherapists and scientists aiding knee OA patients, in the selection of their preferred treatment.

 Method:  Total of 38 sample of (19=experimental group, 19=control group) will be taken from Jamia Millia Islamia, New Delhi, India based on the inclusion exclusion criteria. Subjects will be assigned into whole body vibration and wobble board exercises groups by randomization. Baseline measurements will taken at day one and after 4 weeks of intervention.

 Research design: a randomized, therapy-controlled trial.

 Procedure: All the subjects will be assessed for their demographic characteristics. They will be divided randomly into experimental and control group, respectively. Baseline measurements for pain (NPRS), physical functioning (KOOS), Quality of Life on scales (SF-36), Y-Balance test (YBT) and surface EMG of Quadriceps and Hamstring group of muscle will be taken for both the experimental and control group. Two groups, experimental (n=19) and control (n=19) both will continue their standard medical care and lifestyle modification during the course of study. In addition the experimental group will receive whole body vibration therapy four times a week for 4 weeks and therapy control group will perform wobble board exercises.

 
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