| CTRI Number |
CTRI/2025/02/080755 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Result of walking backward on physical limitations and movement difficulty in long-term knee joint pain in senior citizens by using disability scale WHODAS 2.0 Questionnaire in the age group 60-75 years |
|
Scientific Title of Study
|
Effect of retrowalking on functional disability in chronic knee osteoarthritis among elderly using WHODAS 2.0 Questionnaire- Quasi Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayatri Devendra Madame |
| Designation |
Post-Graduate |
| Affiliation |
Datta Meghe College of Physiotherapy, Nagpur |
| Address |
Department of Community Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri , Hingna Road , Nagpur 441110, MAHARASHTRA , India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
7219429356 |
| Fax |
|
| Email |
gayatri.madame619@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milind Kahile |
| Designation |
Professor |
| Affiliation |
Datta Meghe College of Physiotherapy, Nagpur |
| Address |
Department of Community Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri , Hingna Road , Nagpur 441110, MAHARASHTRA , India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8698715695 |
| Fax |
|
| Email |
milind.sportsphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gayatri Devendra Madame |
| Designation |
Post-Graduate |
| Affiliation |
Datta Meghe College of Physiotherapy, Nagpur |
| Address |
Department of Community Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri , Hingna Road , Nagpur 441110, MAHARASHTRA , India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
7219429356 |
| Fax |
|
| Email |
gayatri.madame619@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe College of Physiotherapy, Wanadongri, Hingna Road, Nagpur-441110, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy |
| Address |
Wanadongri, Hingna road, Nagpur-441110, Maharashtra, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Gayatri Devendra Madame |
Datta Meghe College of Physiotherapy , Nagpur |
Community Physiotherapy OPD, Datta Meghe College of Physiotherapy, Wanadongri,Hingna Road, Nagpur 441110, Maharshtra , India
Nagpur
MAHARASHTRA |
7219429356
gayatri.madame619@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Ayurved Physiotherapy Nursing (APN), Institutional Ethics Committee |
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 |
NIL |
NIL |
| Intervention |
Retrowalking |
practice session of patients for retrowalking with the support of a wall and on a flat surface, a distance of 20 meters at their maximum pace for two sessions to train for the correct backward walking pattern.
the session includes 5 minute of retrowalking following 2 minute of rest time for 30 minutes per session for 4 days a week for 4 weeks, it means 16 sessions per month. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Able to walk independently without any assistive device,
2.Unilateral Knee Osteoarthritis has been diagnosed with a mild to moderate knee Osteoarthritis by a physician and confirmed by
radiograph imaging (Kellgren & Lawrence grade 1–3)
3. Four square step test less than 15 seconds
4. GDS score less than 19
5. Subject BMI below 29.9 |
|
| ExclusionCriteria |
| Details |
1. History or recent compliant of neurological conditions.
2. History of ankle, knee, or hip injury or operated for any within the past 12 months
3. History or recent compliant of cardiovascular problems |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WHODAS 2.0 Questionnaire |
pre-intervention[(Day 1)1st session] - functional disability will be assessed using WHODAS 2.0 Questionnaire
post-intervention[(Day 30) last session]
functional disability will be assessed using WHODAS 2.0 Questionnaire |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Geriatric Depression Scale |
pre-intervention[(Day 1)1st session]
post-intervention[(Day 30) last session]
|
|
|
Target Sample Size
|
Total Sample Size="314"
Sample Size from India="314"
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)
|
03/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Knee OA is a degenerative joint disease characterized by the
gradual breakdown of articular cartilage, leading to pain, stiffness, reduced
mobility, and, in severe cases, disability. It is highly prevalent among older
adults, with risk factors including aging, obesity, sedentary lifestyle. This
study evaluates the effect of retro walking (backward walking) on functional
disability in elderly individuals with chronic knee osteoarthritis using the
WHODAS 2.0 questionnaire. A total of 314 participants, aged 60-75 years, are
selected using a simple random sampling method. To be eligible, participants
must have unilateral knee OA confirmed by radiographic imaging (Kellgren &
Lawrence grade 1–3), be able to walk independently. Individuals with
neurological conditions, recent joint surgeries or injuries, or cardiovascular
conditions that may interfere with movement are excluded from participation. The
primary objective is to determine whether retrowalking significantly improves
physical function and reduces disability in this population. The findings aim
to provide evidence for integrating retrowalking into rehabilitation programs
for osteoarthritis management. The data will be analyzed using appropriate
statistical tests. |