| CTRI Number |
CTRI/2022/08/044584 [Registered on: 02/08/2022] Trial Registered Prospectively |
| Last Modified On: |
01/08/2022 |
| 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 foot exercises which involve shortening the foot performed on Whole Body Vibrator and stationary platform on activation of knee muscle in patients having pain in front of the knee and pain surrounding the knee |
|
Scientific Title of Study
|
Effectiveness of Short Foot Exercises performed with and without Whole Body Vibration on Vastus Medialis Oblique activation in patients with Patellofemoral Pain Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avanti Gaitonde |
| Designation |
PG Student |
| Affiliation |
Dr. D. Y. Patil Vidyapeeth,Pimpri, Pune |
| Address |
PG 2nd Year Classroom, 3rd floor, Opposite to Kinesiotherapy and Movement Sciences Department, Dr. D. Y. Patil College of Physiotherapy,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8928443516 |
| Fax |
|
| Email |
avantigaitonde97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Desai |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune |
| Address |
Department of Musculoskeletal Sciences, 3rd floor, Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9890992383 |
| Fax |
|
| Email |
roopa.desai@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Avanti Gaitonde |
| Designation |
PG Student |
| Affiliation |
Dr. D. Y. Patil Vidyapeeth, Pune |
| Address |
PG 2nd Year Classroom, 3rd floor, Opposite to Kinesiotherapy and Movement Sciences Department, Dr. D. Y. Patil College of Physiotherapy,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8928443516 |
| Fax |
|
| Email |
avantigaitonde97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri,Pune- 411018 |
|
|
Primary Sponsor
|
| Name |
Avanti Gaitonde |
| Address |
PG 2 Classroom, 3rd floor, Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune, Maharashtra- 411018 |
| 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 Roopa Desai |
Dr. D. Y. Patil College of Physiotherapy, Pune |
Physiotherapy OPD, Basement, Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune, Maharashtra
Pune
MAHARASHTRA |
9890992383
roopa.desai@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D. Y. Patil Vidyapeeth, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M222||Patellofemoral disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Short Foot Exercises with Whole Body Vibration on Vastus Medialis Oblique activation in Patellofemoral Pain Syndrome |
Participants will be demonstrated performance of Short Foot Exercises on Whole Body Vibrator. Short Foot Exercises will be performed on Whole Body Vibrator for 4 weeks, 3 days/week. Exercises will be performed for 2 sets, 12 repetitions with 5 seconds hold, in sitting position in 1st and 2nd week. They will be progressed to 4 sets in 3rd and 4th week and will be performed in standing position |
| Comparator Agent |
Short Foot Exercises without Whole Body Vibration on Vastus Medialis Oblique activation in Patellofemoral Pain Syndrome |
Participants will be demonstrated performance of Short Foot Exercises on Stationary platform. Short Foot Exercises will be performed on Stationary platform for 4 weeks, 3 days/week. Exercises will be performed for 2 sets, 12 repetitions with 5 seconds hold, in sitting position in 1st and 2nd week.They will be progressed to 4 sets and will be performed in standing position in 3rd and 4th week. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with Patellofemoral Pain Syndrome
2. Unilateral Patellofemoral Pain Syndrome
3. Chronic Patellofemoral Pain Syndrome |
|
| ExclusionCriteria |
| Details |
1. Acute symptomatic patellofemoral arthritis
2. History of recent surgeries around the knee joint
3. History of knee intra-articular injection of hyaluronic acid or steroid in the last 6 months
4. History of medical problems such as cardiopulmonary diseases, neurological diseases, malignant diseases
5. Structural Flat Feet |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Surface Electromyography(sEMG)
2. Kujala Patellofemoral Score(KPS) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Q- angle |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
05/08/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
NULL HYPOTHESIS Short Foot Exercises performed with Whole Body Vibration and Short Foot Exercises performed without Whole Body Vibration may be equally effective on Vastus Medialis Oblique activation in patients with Patellofemoral Pain Syndrome.
ALTERNATIVE HYPOTHESIS 1)Short Foot Exercises performed with Whole Body Vibration is more effective on Vastus Medialis Oblique activation in patients with Patellofemoral Pain Syndrome than Short Foot Exercises performed without Whole Body Vibration. 2)Short Foot Exercises performed without Whole Body Vibration is more effective on Vastus Medialis Oblique activation in patients with Patellofemoral Pain Syndrome than Short Foot Exercises performed with Whole Body Vibration.
AIM To study the effectiveness of Short Foot Exercises performed with and without Whole Body Vibration on Vastus Medialis Oblique activation in patients with Patellofemoral Pain Syndrome.
OBJECTIVES 1) To examine the effects of Short Foot Exercises with Whole Body Vibration on recruitment of Vastus Medialis Oblique using surface EMG, functional activities using Kujala Patellofemoral score and Q angle. 2) To examine the effects of Short Foot Exercises on recruitment of Vastus Medialis Oblique using surface EMG, functional activities using Kujala Patellofemoral score and Q angle. 3)To compare the effectiveness of Short Foot Exercises performed with and without Whole Body Vibration on recruitment of Vastus Medialis Oblique using surface EMG, functional activities using Kujala Patellofemoral score and Q angle. |