| CTRI Number |
CTRI/2022/12/047859 [Registered on: 02/12/2022] Trial Registered Prospectively |
| Last Modified On: |
28/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Reliability Study of 3 - Meter Backward Walk Test in Older Adults with Knee Osteoarthritis |
|
Scientific Title of Study
|
Inter-rater and Test – Retest Reliability of 3 - Meter Backward Walk Test in Older Adults with Knee Osteoarthritis – A Prospective Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithin Ravindran Nair PT |
| Designation |
Assistant Professor |
| Affiliation |
MGM College of Physiotherapy |
| Address |
MGM College of Physiotherapy, Sector 30 Vashi, Department of Community Physiotherapy Navi Mumbai - 400705
Thane
MAHARASHTRA
400705
India |
| Phone |
7039237411 |
| Fax |
|
| Email |
nithinn11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nithin Ravindran Nair PT |
| Designation |
Assistant Professor |
| Affiliation |
MGM College of Physiotherapy |
| Address |
MGM College of Physiotherapy, Department of Community Physiotherapy Sector 30 Vashi, Navi Mumbai - 400705
Thane
MAHARASHTRA
400705
India |
| Phone |
7039237411 |
| Fax |
|
| Email |
nithinn11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithin Ravindran Nair PT |
| Designation |
Assistant Professor |
| Affiliation |
MGM College of Physiotherapy |
| Address |
MGM College of Physiotherapy, Department of Community Physiotherapy, Sector 30 Vashi, Navi Mumbai - 400705
Thane
MAHARASHTRA
400705
India |
| Phone |
7039237411 |
| Fax |
|
| Email |
nithinn11@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM COLLEGE OF PHYSIOTHERAPY |
|
|
Primary Sponsor
|
| Name |
Dr Nithin Ravindran Nair PT |
| Address |
MGM College of Physiotherapy, Navi 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 NITHIN RAVINDRAN NAIR |
MGM MEDICAL HOSPITAL |
PHYSIOTHERAPY OUT PATIENT DEPARTMENT OPD NO 55 KAMOTHE
Raigarh
MAHARASHTRA |
7039237411
nithinn11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, MGMDCH |
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 |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Older adults of the age 60 years and above
2. Both the genders
3. Having a diagnosis of bilateral osteoarthritis of knee according to 2016 ACR revised criteria.
4. Participants having NPRS score of ≤ 6
|
|
| ExclusionCriteria |
| Details |
1. Any musculoskeletal impairments involving lower extremities (including spine as well), cardiovascular, respiratory or neurological disorders.
2. Individuals with uncontrolled Diabetes mellitus and Hypertension.
3. Participants undergone any surgery recently or any surgical history especially of the lower limb were excluded.
4. Participants with any visual and hearing impairment.
5. Individuals with any psychiatric problem or having difficulty in understanding.
6. Significant or suspected cognitive impairment (inadequate communication ability) - score < 3 in Mini-Cog test
7. Participants having CDC Fall Risk score of 4 or more.
8. Participants who are not willing to participate in this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 3 METER BACKWARD WALK TEST SCORE IN SECONDS |
48 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NPRS and health status using WOMAC (Pune Version). |
48 HOURS |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
05/12/2022 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective study will be conducted as per the “Guidelines
for Reporting Reliability and Agreement Studies (GRRAS)†.Study will be carried out after obtaining approval
from IERC. Before initiating the study following demographic characteristics
of the participants will be collected – age, gender, height, weight, BMI. A familiarization session of 3 meter backward
walk test will be done prior to the initial testing. For Inter-rater
reliability there will be 3 trials performed by the first rater of 3 meter
backward walk test and the average of the 3 trials will be considered.
Following a brief rest of about 10 minutes, the participant will repeat the
entire procedure again with a different rater. Test-retest reliability will be assessed after
an interval of 48 hours keeping the place and timing same as the initial test. Similar procedure as mentioned during inter-rater testing will be
followed.
|