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
|
|
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
|
|
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. |