| CTRI Number |
CTRI/2023/02/049950 [Registered on: 22/02/2023] Trial Registered Prospectively |
| Last Modified On: |
16/02/2023 |
| 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 movement with walking speed, pain and dynamic balance in total knee replacement patients. |
|
Scientific Title of Study
|
Correlation of kinesiophobia with gait speed, pain and dynamic balance in total knee arthroplasty patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyotsna Thosar |
| Designation |
Associate professor |
| Affiliation |
P.T. School and centre, Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre, Seth GS Medical college and KEM
hospital,Acharya Dhonde Marg, Parel (E),Mumbai
Mumbai
MAHARASHTRA
400012
India
P.T.School and centre, Seth GS Medical college and KEM
hospital,Acharya Dhonde Marg, Parel (E),Mumbai
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
jyotsnathosar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyotsna Thosar |
| Designation |
Associate professor |
| Affiliation |
P.T. School and centre, Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre, Seth GS Medical college and KEM
hospital,Acharya Dhonde Marg, Parel (E),Mumbai
Mumbai
MAHARASHTRA
400012
India
P.T.School and centre, Seth GS Medical college and KEM
hospital,Acharya Dhonde Marg, Parel (E),Mumbai
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
jyotsnathosar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Godbole |
| Designation |
Master of Physiotherapy |
| Affiliation |
P.T. School and centre, Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre, Seth GS Medical college and KEM
hospital,Acharya Dhonde Marg, Parel (E),Mumbai
Mumbai
MAHARASHTRA
400012
India
P.T.School and centre, Seth GS Medical college and KEM
hospital,Acharya Dhonde Marg, Parel (E),Mumbai
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9028191745 |
| Fax |
|
| Email |
shrutigodbole34@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.T. School and Centre, Seth GS Medical College and KEM Hospital, Parel(E), Mumbai-12 |
|
|
Primary Sponsor
|
| Name |
Jyotsna Thosar |
| Address |
P.T.School and centre, Seth GS Medical college and KEM
hospital,Acharya Dhonde Marg, Parel (E),Mumbai
Mumbai
MAHARASHTRA
400012
India |
| 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 |
| JyotsnaThosar |
P.T. School and centre, Seth GS Medical college and KEM hospital |
402, ground floor, Physiotherapy department, P.T. School and centre, Seth GS Medical college, Acharya
Dhonde Marg,Parel(E),
Mumbai-12
MAHARASHTRA
Mumbai
MAHARASHTRA |
9821066016
jyotsnathosar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Seth GS Medical College and KEM Hospital |
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
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who had undergone unilateral TKA for degenerative arthritis
2.Patient willing to participate
3.Both the genders |
|
| ExclusionCriteria |
| Details |
1.Patients with history of previous TKA done for contralateral knee
2.Patients with any postoperative compilations
3.Patients with history of any previous knee surgery
4.Fracture near knee joint
5.Diagnosed Rheumatoid arthritis
6.Severe obesity
7.Sensory motor disorder
8.Neuro-musculoskeletal disease that limits lower limb activity.
9.Any neurological condition affecting balance |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Kinesiophobia using Tampa scale of Kinesiophobia (TSK-11)
2.Pain using numerical pain rating scale
3.Gait speed using 10-meter walk test
4.Lateral reach test |
Once |
|
|
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)
|
01/03/2023 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The knee osteoarthritis is a very common condition where severe
osteoarthritis needs surgical management. Primary reasons for having a
total knee arthroplasty (TKA) are pain and functional limitations. Pain
reduction is the major goal of TKA, which results in reduced
Kinesiophobia considerably although Kinesiophobia (fear of movement)
occurs in approximately 1 in 4 patients following TKA. Gait speed
recovery post TKA driven by factors including poorer postural balance
and greater severity of fear induced activity limitation, suggesting that
identifying and treating the underlying physical and cognitive causes of
gait speed limitations may be crucial to optimize functional recovery,
which is an important aspect of post-operative care. 30 unilateral total
knee arthroplasty patients having degenerative osteoarthritis knee will be
recruited for this study. In which Kinesiophobia will be measured by
using Tampa scale of Kinesiophobia, pain using Numerical pain rating
scale, gait speed using 10 meter walk test and dynamic balance using
lateral reach test for both sides. Then the correlation of Kinesiophobia
with gait speed, pain and dynamic balance will be assessed. The data will
be analysed according to the distribution of data using either Pearson or
Spearman rank correlation test. |