| CTRI Number |
CTRI/2024/12/077796 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
01/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Physiotherapy Techniques in Patients with anterior knee pain |
|
Scientific Title of Study
|
Effect Of Retro Walking on Pain, Functional Disability, Quadriceps muscle strength, and Physical performance in Patients with Patellofemoral Pain Syndrome: A Randomized Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suraj Kumar |
| Designation |
Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia |
| Address |
Room No 203
Second Floor
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
New Delhi 110025
South
DELHI
110025
India |
| Phone |
7830337168 |
| Fax |
|
| Email |
skumar2@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suraj Kumar |
| Designation |
Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia |
| Address |
Room No 203
Second Floor
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
New Delhi 110025
South
DELHI
110025
India |
| Phone |
7830337168 |
| Fax |
|
| Email |
skumar2@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shahrukh Hamid |
| Designation |
Student |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia |
| Address |
Room no. 207, Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
New Delhi 110025
South
DELHI
110025
India |
| Phone |
9906595693 |
| Fax |
|
| Email |
shahrukhhamid205@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Jamia Nagar, Okhla, New Delhi, India-110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
New Delhi 110025
India |
| Type of Sponsor |
Other [Central University] |
|
|
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 Suraj Kumar |
Jamia Millia Islamia |
Out patient department, ground floor, Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
New Delhi 110025
India
South
DELHI |
7830337168
skumar2@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Jamia millia islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group: Standard physiotherapy care |
Standard physiotherapy rehabilitation program includes straight leg raising, isometric quadriceps, isometric hip adduction, terminal knee extension, semi-squat, and leg press are comprised of the programs closed kinetic chain and open kinetic chain components. All participants also get continuous ultrasonic therapy for seven minutes at 1.5 watts per cm2 for 7 mins in continuous mode. Participants will be instructed by a trained physiotherapist and will be asked to perform exercises 3 days a week for 6 weeks. each session will be of 30 minutes |
| Intervention |
Forward walking group |
Participants in the forward walking group will also undergo regular physiotherapy (open and close kinetic exercise of hip and knee)in addition to it 10 minutes of supervised forward walking training starting with a speed of 3km/hr on treadmill along with 5-minute warm-up and cool-down sessions will be done for three days a week for six weeks at their comfortable walking speed. Each session will be of 45 minutes |
| Intervention |
Retrowalking group |
The participants in the retro walking group will undergo regular physiotherapy (open and close kinetic chain exercises of hip and knee) in addition to it 10 minutes of supervised retro walking training starting with a speed of 3km/hr on treadmill along with 5-minute warm-up and cool-down sessions will be done for three days a week for six weeks at their comfortable walking speed.
Each session will be of 45 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged 18-35 years and diagnosed with patellofemoral pain.
Anterior or retropatellar knee pain for past 6 months.
Pain score ranged from 2–5 on the 10-cm visual analogue scale.
Reporting at least two of the following activities exacerbated their symptoms: prolonged sitting, ascending or descending stairs, squatting, kneeling.
|
|
| ExclusionCriteria |
| Details |
Patellar dislocation or subluxation, a recent history of knee surgery (within three months).
Osteoarthritis, rheumatoid arthritis, meniscal lesion, patellar tendon pathology, traction apophysitis around the patellofemoral complex, ligamentous instability, and spinal referred pain.
Experiencing difficulty walking due to a cardiovascular issue
Diabetes can lead to reduced sensation in the legs, altering gait and increasing the risk of further knee injury or strain, which can aggravate PFPS.
Dependency on assistive devices for walking.
Neurological conditions or cognitive impairment affecting instruction comprehension.
Recent participation in PFPS rehabilitation programs.
Pregnancy due to potential hormonal influences on pain perception and gait.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome: Pain and functional disability
|
Baseline and after 6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quadriceps muscle strength
Physical performance |
Baseline and after 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
12/12/2024 |
| 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="6"
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
|
Subjects
will be recruited at Out patient department, CPRS, Jamia Millia Islamia University according to
inclusion and exclusion criteria, three groups will be
established: Group A: Retrowalking, Group B: Forward walking, Group C: Control
group and a baseline assessment of all the outcome parameters i.e. pain assessed through NPRS, functional disability assessed via Kujala scale, Quadriceps muscle strength assessed through dynamometer and physical performance through timed up and go test. After randomly allocating all the individuals to
the groups, all participants will receive standard physiotherapy rehabilitation and additional retrowalking and forward walking in their respective group for 6 weeks, thrice a week. |