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CTRI Number  CTRI/2024/07/069756 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 17/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Correlation Of Fear Of Fall With Balance And Pain In Patients Post 6 Months of Total Knee Replacement Done On Both Knees. 
Scientific Title of Study   Correlation Of Fear Of Fall With Balance And Pain In Patients With Bilateral Total Knee Arthroplasty Post 6 Months.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyotsna Thosar 
Designation  Assistant Professor 
Affiliation  P.T School and Centre, Seth GS Medical College and KEM Hospital 
Address  OPD No. 402, P.T School and Centre, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel East, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9821066016  
Fax    
Email  jyotsnathosar@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jyotsna Thosar 
Designation  Assistant Professor 
Affiliation  P.T School and Centre, Seth GS Medical College and KEM Hospital 
Address  OPD No. 402, P.T School and Centre, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel East, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9821066016  
Fax    
Email  jyotsnathosar@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Shrutika Bachal 
Designation  Master Of Physiotherapy 
Affiliation  P.T School and Centre, Seth GS Medical College and KEM Hospital 
Address  OPD No. 402, P.T School and Centre, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel East, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  7718041075  
Fax    
Email  shrutikabachal15@gmail.com  
 
Source of Monetary or Material Support  
P.T School and Centre, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India 400012. 
 
Primary Sponsor  
Name  Dr. Jyotsna Thosar 
Address  OPD No. 402, P.T School and Centre, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel East, Mumbai 
Type of Sponsor  Other [Self] 
 
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 Jyotsna Thosar  P.T School and Centre, Seth GS Medical College and KEM Hospital  OPD No. 402, P.T School and Centre, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel East, Mumbai
Mumbai
MAHARASHTRA 
9821066016

jyotsnathosar@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) - II Relating to Biomedical and Health Research(BHR). Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients who had undergone bilateral TKA
for degenerative arthritis between 6 months to 1 year.
2. Patients in the age group of 50 - 70 years.
3. Patients willing to participate.
4. Both the genders.
5. Patients who can read and write either Marathi or Hindi or English.
 
 
ExclusionCriteria 
Details  1. Patients with Revision Total Knee Arthroplasty.
2. Patients with any known postoperative complications like joint infection, loosening of prosthesis, etc.
3. Patients with any known history of previous knee surgery.
4. Any known traumatic, inflammatory, neurological, vestibular and, vascular conditions affecting either lower limb.
5. Patients with any known psychological conditions.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Fall Efficacy Scale International
2. Timed Up and Go Test.
3. Visual Analogue Scale. 
Once 6 Months Post Bilateral Total Knee Arthroplasty  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/07/2024 
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="0"
Months="6"
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  

After six months of total knee replacement surgery, the patient is expected to be performing all daily activities, such as driving, shopping, and cooking, and to be nearly normal in society. This calls for multitasking, ambulating in crowded locations, and having adequate lower limb function. Functional recovery is important to be able to perform daily activities as well as participate in a community. Fear of Fall can affect this ability. Therefore, this study aims to find Correlation of Fear of Fall with Balance and Pain in patients with bilateral total knee arthroplasty post 6 months. 30 participants will be selected based on the inclusion and exclusion criteria. Informed consent will be taken and if they agree to participate in this study, they will be included in the study. A one-time assessment of 15-20 minutes will be performed. They will be asked about their demographic data (name, age, etc.). Their Fear of Fall will be assessed using Fall Efficacy Scale International. It has 16 Questions where each question has 4 possible responses: 1-not at all concerned; 2-somewhat concerned; 3-fairly concerned; 4-very concerned. They will be asked to mark an option that is appropriate for them. Next, the Timed Up and Go (TUG) test will be taken. In this, the participant will sit in the chair with their back against the chair back. On the command “go”, he/she will rise form the chair, walk 3 meters at a comfortable and safe pace, turn, walk back to the chair and sit down. Timing will begin at the instruction “go’ and stop when they are seated. They will have one practice trial that is not included in the score. Then Pain will be assessed using Visual Analogue Scale, in this a 10 cm line will be drawn and patient will be asked to mark a point between 2 endpoints (No pain at all and Worst Possible pain) and The distance between ‘no pain at all’ and the mark then defines the patient’s pain. Once all the data has been collected, it will be analyzed using the statistical tests. Depending upon the normality of the data, Pearson’s or Spearman’s coefficient will be calculated.

 
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