| CTRI Number |
CTRI/2024/07/071670 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Home-Based Modified Otago Exercises on Balance in Older Adults with Knee Osteoarthritis |
|
Scientific Title of Study
|
Effect of home based modified Otago exercise on balance among elderly adults with OA knee |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vini Marlo A |
| Designation |
Post Graduate Student |
| Affiliation |
SRM College Of Physiotherapy SRM Institute of Science and Technology |
| Address |
Room No:PT05 5th floor SRM College Of Physiotherapy SRM
Medical College Hospital and Research Center SRM Nagar Potheri
Kattankulathur Chengalpattu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894505242 |
| Fax |
|
| Email |
vm6005@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Yasmeen Imtiaz G |
| Designation |
Assistant Professor |
| Affiliation |
SRM College Of Physiotherapy SRM Institute of Science and Technology |
| Address |
Room No:PT05 5th floor SRM College of Physiotherapy SRM
Medical College Hospital and Research Center SRM NAGAR Potheri
Kattankulathur Chengalpattu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500182105 |
| Fax |
|
| Email |
yasmeeng@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Yasmeen Imtiaz G |
| Designation |
Assistant Professor |
| Affiliation |
SRM College Of Physiotherapy SRM Institute of Science and Technology |
| Address |
Room No:PT05 5th floor SRM College of Physiotherapy SRM
Medical College Hospital and Research Center SRM NAGAR Potheri
Kattankulathur Chengalpattu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500182105 |
| Fax |
|
| Email |
yasmeeng@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur
Chengalpattu Kancheepuram Tamil Nadu India 603203 |
|
|
Primary Sponsor
|
| Name |
Vini Marlo A |
| Address |
Room No:PT05 5th floor SRM College of Physiotherapy SRM
Medical College Hospital and Research Center SRM NAGAR Potheri
Kattankulathur Chengalpattu Kancheepuram Tamil Nadu India
603203 |
| 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 Yasmeen Imtiaz G MPT |
SRM department of physiotherapy |
SRM Institute Of
Science And
Technology
Kattankulathur
Chengalpattu 603203
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
9500182105
yasmeeng@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Home based modified Otago exercise for OA knee |
Exercise will prescribed by using EARS(exercise adherence scale)a brief 6-item scale that asks
participants to describe how they do their recommended exercises on a 5-point
scale
Respondent burden - 12 minutes
Knee bends
Backwards walking
Walking and turning around
Sideways walking
Sit to stand
Stair walking |
| Comparator Agent |
Without Otago exercise |
Patient education will be taught |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Bilateral OA,WOMAC scoring above 70 out of 96, Patient takes above 20 seconds to perform TUG test
, community balance and mobility scale score above 50 |
|
| ExclusionCriteria |
| Details |
Rheumatoid Arthritis
Fractures
Neurological Impairment
Lower-limb Surgery- TKR,THR
DVT,Varicose vein |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WOMA(Western Ontario and McMaster Universities Osteoarthritis Index) |
Before Intervention (Pre-test) and After 8
weeks(post-test) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TUG TEST |
Before Intervention (Pre-test) and After 8
weeks(post-test) |
| COMMUNITY BASED MOBILITY SCALE |
Before Intervention (Pre-test) and After 8
weeks(post-test) |
|
|
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)
|
15/08/2025 |
| 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="4"
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
|
EXERCISE PROTOCOL Based on the EARS scoring Exercise should be modified Schedule for 5 days a week for 8 weeks Duration -30 to 45 minutes EXERCISE PROTOCOL MODIFIED HOME BASED OTAGO EXERCISES Knee bends Backwards walking Walking and turning around Sideways walking Sit to stand Stair walking |