| CTRI Number |
CTRI/2024/11/076548 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| 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
|
Effect of stabity trainer exercise program on fear of movement, pain, lower limb functionality in person with Anterior knee pain syndrome |
|
Scientific Title of Study
|
Effect of 4-Weeks stability trainer exercise program on balance, kinesiophobia, pain,functionality of lower limb in individuals with Patellofemoral pain syndrome- 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 |
Hhitika Kapoor |
| Designation |
PG student |
| Affiliation |
S.S agrawal institute of physiotherapy and medical care education , navsari |
| Address |
Ortho out patient department, ground floor, s.s. agrawal institute of physiotherapy, agrawal college campus, verranjali marg 1 , devina park, navsari.
GUJARAT
396445
Navsari
GUJARAT
396445
India |
| Phone |
8160235844 |
| Fax |
|
| Email |
hhitika78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shlesha Vaidya |
| Designation |
Principal/assistant professor, PG Guide and Phd scholar |
| Affiliation |
S S Agrawal Institute of physiotherapy and medical care education |
| Address |
Ortho out patient department, ground floor, s.s. agrawal institute of
physiotherapy, agrawal college campus, verranjali marg 1 , devina park, navsari.
GUJARAT
396445
Navsari
GUJARAT
396445
India |
| Phone |
9427285250 |
| Fax |
|
| Email |
drsmvaidya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shlesha Vaidya |
| Designation |
Principal/assistant professor, PG Guide and Phd scholar |
| Affiliation |
S S Agrawal Institute of physiotherapy and medical care education |
| Address |
Ortho out patient department, ground floor, s.s. agrawal institute of
physiotherapy, agrawal college campus, verranjali marg 1 , devina park, navsari.
GUJARAT
396445
Navsari
GUJARAT
396445
India |
| Phone |
9427285250 |
| Fax |
|
| Email |
drsmvaidya@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.S agrawal institute of physiotherapy and medical care education, navsari, gujarat. 396445
agrawal college campus, out patient department, verranjali 1 marg, devina park, navsari. |
|
|
Primary Sponsor
|
| Name |
Hhitika Kapoor |
| Address |
121, Shakti nagar chhapra road, near ganesh farm Navsari , Gujarat 396445 |
| 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 Shlesha Vaidya |
S.S.agrawal institute of physiotherapy and medical care education, navsari |
Department of
physiotherapy,ground
floor, agrawal college
campus, viranjali van
marg, devina park,
navsari
Navsari
GUJARAT
Navsari
GUJARAT |
9427285250
drsmvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.S Agrawal Institute Ethical Committee |
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 |
Group 1 :Stability trainer exercise program
|
Group 1
Convenstional exercise plus Week 1 Balance Training on green stability trainer
Week 2 Balance Training on Blue stability trainer
Week 3 Balance Training on Black stability trainer
Week 4 Balance Training on black stability trainer
|
| Comparator Agent |
Group 2: Conventional Exercise |
Group 2 Strengthening, Stretching exercise of hip and core Progession according to 6 RM |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Already diagnosed case of PFPS by orthopedic surgeon.
• Individuals with unilateral anterior knee pain.
• Age: 18-45 Years
• Patients with anterior knee pain fitting in the diagnostic criteria for PFPS.
i. Medial or Lateral patellar facet tenderness
ii. Positive Clarke test
iii. Positive Patellar Apprehension test
iv. Positive Patellar Tilt test
• Onset of pain lasting for more than one month and exacerbated by at least two of the
following activities: prolonged sitting, squatting, kneeling, running, ascending/descending
stairs, jumping, and landing
• VAS: 3-7cm |
|
| ExclusionCriteria |
| Details |
• Any neurological impairment in lower limb.
• History of lower limb fractures or surgery.
• Dislocation or subluxation in the patellofemoral joint.
• Any signs of secondary osteoarthritis in the knee joint.
• History meniscus and/or other knee ligament injury
• Patellar tendinopathy
• Knee intra-articular injection within the previous three months.
• Systemic or local infections.
• Patient taking any analgesic medication from past 1 week. |
|
|
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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain assessment: VAS scale.
• Static balance: Single leg balance test
• Dynamic balance: Star excursion balance test
• Lower limb Functionality: KOOS Scale
• Kinesiophobia assessment: Tampa scale |
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
15/11/2024 |
| 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="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
|
AIM OF THE STUDY • The aim of the study is to find the effect of 4-week of stability trainer exercise program in individuals with Patellofemoral pain syndrome. OBJECTIVES • To investigate the effectiveness of a targeted 4-week stability trainer exercise program in improving balance, reducing Kinesiophobia, alleviating pain, and enhancing the functionality of the lower limb in individuals diagnosed with Patellofemoral Pain Syndrome. • To compare the effect of stability trainer exercise plus conventional therapy with conventional therapy alone on balance, Kinesiophobia, pain and functionality in individuals with Patellofemoral pain syndrome. |