| CTRI Number |
CTRI/2023/10/059037 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
21/10/2023 |
| 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 body balance exercise versus movement exercise to improve flexibility and strength
pain and check the muscle property: A Comparative Study" |
|
Scientific Title of Study
|
"Effect of pilates exercise versus functional stabilization exercise on pain and muscle activation ration of vastus medialis obliqus (VMO) and
Vastus lateralis (VL) in
Patellofemoral pain: A Comparative 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 |
Ruchita vasava |
| Designation |
MPT scholar |
| Affiliation |
Parul institute of physiotherapy, parul University, vadodra |
| Address |
Parul institute of physiotherapy Parul University vadodra
Vadodara
GUJARAT
393010
India |
| Phone |
9265077587 |
| Fax |
|
| Email |
ruchu972000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandip parekh |
| Designation |
Professor |
| Affiliation |
Parul institute of physiotherapy and Research |
| Address |
Parul institute of physiotherapy and Research Parul University Limda vadodra
Vadodara
GUJARAT
390019
India |
| Phone |
9727081135 |
| Fax |
|
| Email |
parekh.sandip3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandip parekh |
| Designation |
Professor |
| Affiliation |
Parul institute of physiotherapy and Research |
| Address |
Parul institute of physiotherapy and Research Parul University Limda vadodra
Vadodara
GUJARAT
390019
India |
| Phone |
9727081135 |
| Fax |
|
| Email |
parekh.sandip3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Center of Research for Development (CR4D), Publication Division, 1st floor, Room No. 110, Parul Institute of Medical Sciences (PIMSR), Parul University, P.O. LIMDA, Ta. Waghodia- 391760, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Parul University |
| Address |
Center of Research for Development (CR4D), Publication Division, 1st floor, Room No. 110, Parul Institute of Medical Sciences (PIMSR), Parul University, P.O. LIMDA, Ta. Waghodia- 391760, Gujarat, 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 |
| Ruchita vasava |
Parul Sevashram Hospital |
PG room no 401,4th floor,parul institute of physiotherapy,faculty of physiotherapy,parul university limda, waghodiya,vadodra
Vadodara
GUJARAT |
9265077587
ruchu972000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University institutional Ethics committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patellofemoral pain syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Functional Stabilization Exercise |
1)Transverse abdominis and
Multifidus muscle training with
physio ball "5 repetition 20 seconds hold"
2) Isometric hip
abduction/lateral rotation in
standing "5 repetition 20 seconds hold"
3) Hip abduction/lateralrotation
extension in side lying "20 repetition 5 seconds hold"
4) Hip extension and Lateral
rotation in prone "20 repetition 5 seconds hold"
5) Hip abduction/ lateral
rotation with slight knee and hip
flexion in side lying "20 repetition 5 seconds hold"
6)lateral bridge and Ventral
bridge "5 sets 30 seconds hold"
7)Trunk extension on physio
ball " 3 sets 12 repetition "
8)Hip abduction/ lateral
rotation/extension "3 sets 12 repetition "
9)Hip extension/lateral rotation
in prone "3 sets 12 repetition "
10) Hip abduction/lateral rotation
with slight knee and hip flexion
in side lying "3 sets 12 repetition"
11)Plevic drop in standing "3 sets 12 repetition "
12)Hip lateral rotation in closed
kinetic chain "3 sets 12 repetition "
13) Singal leg deadlift "3 sets 12 repetition " |
| Intervention |
Pilates exercise |
1)Hundred exercise "5 repetition 3 sets "
2) Single Leg stretch "5 repetition 3 sets"
3) Plank "5 repetition 3 sets "
4) Standing foot work "5 repetition 3 sets"
5) Hip twist "5 repetition 3 sets
6)side kick internal/external
rotation with band "5 repetition 3 sets"
7)Squat exercise" 5 repetition 3 sets
8)Swimming with stabilization
ball "5 repetition 3 sets"
9)Wall squt rolls " 5 repetition 3 sets" |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Pain in anterior knee and retropatellar area during at least 2 or more following activities
1)Ascending / descending stairs
2) Prolong sitting
3)Running
4)Squtting |
|
| ExclusionCriteria |
| Details |
1)Intra articlur pathology
2)Involvement volvement of cruciate or collateral ligament
3) History of Hip pain
4) History of Patellar instability
5) Any previous surgery in lower limb |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale |
Outcome will be assessed at baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Electromyography for the vastus medialis obliqus and vastus lateralis muscle activation ratio |
3 session per week for 4 consecutive weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/10/2023 |
| 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
|
"Effect of pilates exercise versus functional stabilization exercise on pain and muscle activation ratio of vastus medialis obliqus and vastus lateralis in patellofemoral pain:A COMPARATIVE STUDYAim- aim of study is to examin the pilates Exercise Versus Functional Stabilization Exercise on pain and electromyographic muscle activation ratio for VMO and VL in individual with patellofemoral pain |