| CTRI Number |
CTRI/2025/03/082517 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Effects of Backward Walking on Running Style, Nerves, and Knee Pain Relief. |
|
Scientific Title of Study
|
IMPACT OF RETRO-WALKING ON ELECTRO-PHYSIOLOGICAL, GAIT AND FUNCTIONAL PARAMETERS IN RUNNERS WITH PATELLOFEMORAL PAIN SYNDROME |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Raghav |
| Designation |
PG Student |
| Affiliation |
SGT University |
| Address |
Department of faculty of physiotherapy, SGT University Chandu Budhera Department of faculty of physiotherapy, SGT University Chandu Budhera Gurgaon HARYANA 122505 India |
| Phone |
9599268613 |
| Fax |
|
| Email |
nikhilraghav1802@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pooja Bhati |
| Designation |
Assistant professor |
| Affiliation |
SGT University |
| Address |
Department of faculty of physiotherapy, SGT University Chandu Budhera Department of faculty of physiotherapy, SGT University Chandu Budhera Gurgaon HARYANA 122505 India |
| Phone |
8802192456 |
| Fax |
|
| Email |
pooja.bhati092@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pooja Bhati |
| Designation |
Assistant professor |
| Affiliation |
SGT University |
| Address |
Department of faculty of physiotherapy, SGT University Chandu Budhera Department of faculty of physiotherapy, SGT University Chandu Budhera Gurgaon HARYANA 122505 India |
| Phone |
8802192456 |
| Fax |
|
| Email |
pooja.bhati092@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of physiotherapy, SGT University, Chandu, Budhera, 122505 |
|
|
Primary Sponsor
|
| Name |
Nikhil Raghav |
| Address |
Faculty of physiotherapy, SGT University, Chandu, Budhera, 122505 |
| 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 |
| Nikhil Raghav |
SGT Medical college |
Faculty of physiotherapy, SGT University, Chandu, Budhera, 122505 Gurgaon HARYANA |
9599268613
nikhilraghav1802@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty Of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A- Conventional Treatment Alone |
A 30-minute duration of the session will be conducted. The treatment includes conventional protocol. 10 minutes TENS will be given to the patient followed by 20-minute exercise program (Quadriceps strengthening, ITB stretch, Hamstring stretch).
|
| Intervention |
Group B- Addition of Retro-Walking with conventional intervention |
A 30-minute duration of each session will be conducted. 15-minute exercise program (Quadriceps strengthening, ITB stretch, Hamstring stretch). Then a 15-minute treadmill retro walking will be incorporated. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants age between 18 and 35 years.
2.Anterior or retro-patellar knee pain after performing, at least, two of the following activities; prolonged sitting, stair climbing, squatting, running, kneeling, hopping/jumping and deep knee flexion.
3.Pain score ranging from 2 to 5 on the 10-cm visual analog scale (VAS).
4.Pain duration should be at least for two months.
5.At least two positive signs of the following were found during examination; pain and/or patellar crepitus following patellar compression test, 5] pain following resisted knee extension, Clarke’s sign; pain following isometric quadriceps contraction against suprapatellar resistance with the knee in slight flexion, tenderness upon palpation of the posterior surface of the patella or surrounding structures, and having negative findings on examination of the knee ligaments, menisci, and bursa.
6.Participant should be involved in running sports at least 1 year and train at least on an average five times a weak. |
|
| ExclusionCriteria |
| Details |
1.Those having had clinical evidence of meniscal or ligamentous injury.
2.History of patellar subluxation or dislocation.
3.Tenderness over the patellar tendon.
4.A recent history of knee or any lower limb surgery, or spinal referred pain were excluded.
5.Any Cardiopulmonary condition and Neurological disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.EMG of VMO and VL muscles of knee.
2. Running Gait parameters. |
Day 1 assessment and after 4th weak assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Pain (NPRS, Kujala Anterior Knee Pain Scale) |
Day 1 assessment and after 4th weak assessment |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
22/03/2025 |
| 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="0" 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
|
Patellofemoral Pain Syndrome (PFPS), commonly known as "runner’s knee," is a prevalent musculoskeletal condition that causes pain around or behind the patella, particularly during weight-bearing activities like running, squatting, and stair climbing. Despite its high occurrence among athletes, there is no universally accepted treatment, though strengthening exercises, especially for the quadriceps, have shown benefits. Recent studies suggest that retro-walking (backward walking) may reduce joint stress, improve quadriceps strength, and enhance knee function, but its long-term effects in runners with PFPS remain unexplored. This study aims to assess whether retro-walking, when added to conventional treatment, offers superior outcomes in terms of pain relief, muscle activation, range of motion, and functional performance compared to conventional treatment alone. If proven effective, this intervention could refine rehabilitation protocols, providing a cost-effective and innovative approach for athletes and physiotherapists. The research is guided by the hypothesis that retro-walking will lead to significant improvements in clinical and functional outcomes, while the null hypothesis assumes no significant difference between the two treatment methods. Through pain scales, gait analysis, EMG readings, and strength assessments, this study seeks to establish the role of retro-walking in PFPS rehabilitation. |