| CTRI Number |
CTRI/2024/05/067168 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of knee joint position sense with balance while body is moving and physical function in individuals with osteoarthritis of the knee between 60-80 years of age |
|
Scientific Title of Study
|
Correlation of knee joint proprioception with dynamic balance and physical function in individuals with osteoarthritis of the knee between 60-80 years of age |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preksha Phadke |
| Designation |
Postgraduate student of physiotherapy |
| Affiliation |
AIIPMR, Mumbai |
| Address |
AIIPMR, Keshavrao Khadye Marg, Haji Ali Government col., Mahalakxmi, Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
7420015611 |
| Fax |
|
| Email |
prekshaphadke15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Dolas |
| Designation |
Lecturer, Physiotherapy |
| Affiliation |
AIIPMR, Mumbai |
| Address |
AIIPMR, Keshavrao Khadye Marg, Haji Ali Government col., Mahalakxmi, Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9820384812 |
| Fax |
|
| Email |
vsdolas21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Dolas |
| Designation |
Lecturer, Physiotherapy |
| Affiliation |
AIIPMR, Mumbai |
| Address |
AIIPMR, Keshavrao Khadye Marg, Haji Ali Government col., Mahalakxmi, Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9820384812 |
| Fax |
|
| Email |
vsdolas21@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIPMR, Mahalaxmi, Mumbai, 34 |
|
|
Primary Sponsor
|
| Name |
Preksha Phadke |
| Address |
Physiotherapy department AIIPMR, Keshavrao Khadye Marg, Haji Ali Government col., Mahalakxmi, Mumbai- 400034 |
| 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 Preksha Phadke |
AIIPMR, Mumbai |
Room No. 224, Physiotherapy department, AIIPMR, Mahalaxmi, Mumbai, 34
Mumbai
MAHARASHTRA |
7420015611
prekshaphadke15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, AIIPMR, Mumbai |
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 |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals between the age group of 60-80 years
2.Individuals with radiologically diagnosed bilateral knee osteoarthritis (grade II and III as per KL grading system)
3.Pain intensity reduced to ≤ 3 on NPRS scale after undergoing conventional therapy.
|
|
| ExclusionCriteria |
| Details |
1.Any medical or surgical condition that will restrict the performance of the test.
2.Any skeletal deformity.
3.History of intra- articular injection therapy in previous 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Joint reposition sense
2.Timed up and go test
3. Lequesne Algofunctional Index Of Knee Osteoarthritis |
One time observation is the baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
17/05/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
TITLE: CORRELATION OF KNEE JOINT PROPRIOCEPTION WITH DYNAMIC BALANCE AND PHYSICAL
FUNCTION IN INDIVIDUALS WITH OSTEOARTHRITIS OF THE KNEE BETWEEN 60-80 YEARS OF
AGE
SUBJECT SELECTION CRITERIA
INCLUSION CRITERIA
1.
Individuals
between the age group of 60-80 years
2.
Individuals
with radiologically diagnosed bilateral knee osteoarthritis (grade II and III
as per KL grading system)
3.
Pain
intensity reduced to ≤ 3 on NPRS scale after undergoing conventional therapy.
EXCLUSION CRITERIA
1.
Any
medical or surgical condition that will restrict the performance of the test.
2.
Any
skeletal deformity.
3.
History
of intra- articular injection therapy in previous 6 months.
Participants giving informed consent will be included in the study . Participant will undergo study protocol. Data collected from the study will be statistically analyzed. |