| 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
|
|
|
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
|
|
|
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 “goâ€, 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. |