| CTRI Number |
CTRI/2024/04/065323 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Retro walking along with Otago exercise for Primary Unilateral tibiofemoral osteoarthritis of knee to reduce pain, improve balance and functional mobility |
|
Scientific Title of Study
|
Effects of Retro walking along with Otago exercise on pain , balance and functional mobility in Primary Unilateral Tibio-Femoral osteoarthritis of 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 |
PGeerthana |
| Designation |
MPT orthopaedics student |
| Affiliation |
Sri Ramakrishna institute of paramedical sciences |
| Address |
Sri Ramakrishna institute of paramedical sciences departemnt of physiotherapy ,orthopedic division room no 4016 ,395 Sarojini naidu road , sidhapudhur , coimbatore ,Tamilnadu
Coimbatore
TAMIL NADU
641044
India |
| Phone |
7418594493 |
| Fax |
|
| Email |
geerthiparath1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vs seetharaman |
| Designation |
MPT orthopaedics professor |
| Affiliation |
Sri Ramakrishna institute of paramedical sciences |
| Address |
Sri Ramakrishna institute of paramedical sciences ,395 Sarojini naidu road , sidhapudhur , coimbatore ,Tamilnadu
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9842744406 |
| Fax |
|
| Email |
principal@sriramakrishnacollegeofphysiotherapy.com |
|
Details of Contact Person
Public Query
|
| Name |
PGeerthana |
| Designation |
MPT orthopaedics student |
| Affiliation |
Sri Ramakrishna institute of paramedical sciences |
| Address |
Sri Ramakrishna institute of paramedical sciences departemnt of physiotherapy ,orthopedic division room no 4016 ,395 Sarojini naidu road , sidhapudhur , coimbatore ,Tamilnadu
Coimbatore
TAMIL NADU
641044
India |
| Phone |
7418594493 |
| Fax |
|
| Email |
geerthiparath1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| self,Sri Ramakrishna institute of paramedical sciences departemnt of physiotherapy ,orthopedic division room no 4016 ,395 Sarojini naidu road , sidhapudhur , coimbatore ,Tamilnadu |
|
|
Primary Sponsor
|
| Name |
PGeerthana |
| Address |
Sri Ramakrishna institute of paramedical sciences departemnt of physiotherapy ,orthopedic division room no 4016 ,395 Sarojini naidu road , sidhapudhur , coimbatore ,Tamilnadu |
| Type of Sponsor |
Other [[other,self (Part of master programme]] |
|
|
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 |
| DrGokul krishna |
Physiotherapy departmrnt sri ramakrishna multispeciality hospital |
sri ramakrishna institute of paramedical and sciences, room number 4017, physiotherapy department,395 sarojini naidu road ,coimbatore
Coimbatore
TAMIL NADU |
7418594493
drgokul1977.ortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri ramakrishna hospital ethical comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
otago exercise |
30 minutes with alternate days for 6 weeks |
| Intervention |
Retro walking along with otago exercise |
45 minutes with alternate days for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Gender both male and female,age group 45 to 55, unilateral tibio-femoral osteoarthritis of knee, mild and moderate grade according to kellgren and lawrence scale, NPRS score mre than 5, berg balance score nearly 47, time up and go score who takes more than 15 sec to 25 sec |
|
| ExclusionCriteria |
| Details |
subjects with any neurological or cardiorespiratory conditions,joint replacement surgery, spinal surgery or any other lower limb surgery on the affected side of knee,lower limb deformity and fracture, chondromalacia patella,ligament and menisci repair , obesity BMI greater than 30,subject who using walking aids and knee braces |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Balance
Functional mobility |
6 weeks |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/04/2024 |
| 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="0"
Days="8" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [geerthiparath1999@gmail.com].
- For how long will this data be available start date provided 09-10-2024 and end date provided 09-10-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
EFFECT OF RETRO WALKING ALONG WITH OTAGO EXERCISE ON PAIN BALANCE AND FUNCTIONAL MOBILITY IN PRIMARY UNILATERAL TIBIOFEMORAL OSTEOARTHRITIS OF KNEE
BACKGROUND:
Osteoarthritis is a progressive disorder of joints caused by gradual loss of cartilage resulting in the development of bony spurs. It result in imbalance increase , pain and decrease functional mobility .Retro walking along with Otago exercise are suspected to effective in improving pain , balance and functional mobility.
PURPOSE:
The aim is to explore the effects of retro walking along with Otago exercise on pain, balance and functional mobility in primary unilateral tibiofemoral osteoarthritis of knee
METHODOLOGY:
A total of 30 subjects age between 45 to 55 years both male and female were included and treatment duration 6 weeks |