| CTRI Number |
CTRI/2025/04/085429 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Gluteus Maximus Strengthening Versus Gluteus Medius Strengthening Exercises on the Medial Longitudinal Arch in Individuals with Asymptomatic Flexible Flatfoot |
|
Scientific Title of Study
|
Comparison of the Effects of Gluteus Maximus Strengthening Versus Gluteus Medius Strengthening Exercises on the Medial Longitudinal Arch in Individuals with Asymptomatic Flexible Flatfoot |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajeshwari Ade |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur |
| Address |
Department of Musculoskeletal Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
08888185624 |
| Fax |
|
| Email |
rajade1408@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Deshmukh |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur |
| Address |
Department of Musculoskeletal Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
08888185624 |
| Fax |
|
| Email |
nehadeshmukh57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajeshwari Ade |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur |
| Address |
Department of Musculoskeletal Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
08888185624 |
| Fax |
|
| Email |
rajade1408@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe College of Physiotherapy, Wanadongri, Hingna Road, Nagpur 441110, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy, Nagpur |
| Address |
Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 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 |
| Dr Rajeshwari Ade |
Datta Meghe College of Physiotherapy, Nagpur |
Out patient department, Department of Musculoskeletal Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA |
08888185624
rajade1408@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Ayurved, Physiotherapy, Nursing (APN) Colleges Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M248||Other specific joint derangements,not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gluteus maximus strengthening with foot exercise |
The patient in the group of Gluteus maximus strengthening will perform exercises involving active prone hip extension in different positions
Progression 1: knee flexion
Progression 2: lateral hip rotation and knee extension
Progression 3: lateral hip rotation and knee flexion
• Foot exercises (common for both the group)
Foot active range of motion exercises (3 sets of 15
repetitions)
Foot curls (3 sets of 15 repetitions)
Foot roller (3 sets of 15 repetitions)
Calf raises (3 sets of 15 repetitions) |
| Comparator Agent |
gluteus medius strengthening with foot exercise |
The patient in the group of Gluteus maximus strengthening the clamshell exercise will be
used. Progression 1: To raise the top knee and return to the
starting position, individuals externally rotated their top hip. Progression 2: Participant internally rotated the upper hip
while maintaining their knees together and then they
reverted to their initial posture. Progression 3: Before resuming the initial position
participants elevated their upper thighs parallel to the floor
and raised their feet towards the ceiling, forcing their hips to internally spin.
Progression 4: With the upper hip completely extended
• Foot exercises (common for both the group)
Foot active range of motion exercises (3 sets of 15
repetitions)
Foot curls (3 sets of 15 repetitions)
Foot roller (3 sets of 15 repetitions)
Calf raises (3 sets of 15 repetitions) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 Both male and female.
2 Individual with age from 18 years to 30 years
3 Individual with asymptomatic flexible flatfoot
4 Navicular drop more than or equals to 10mm |
|
| ExclusionCriteria |
| Details |
1) Lower extremity surgery
2) Injury to the lower extremities
3) Any history of pain
4) Congenital or acquired deformities of lower extremity
5) Neurological conditions involving the lower extremities |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
navicular drop test
foot posture index |
1. baseline (0 weeks)
2. post treatment ( 2 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
12/05/2025 |
| 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="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
|
Ethical clearance is given from the ethical committee prior to the commencement of study. Participants shall be selected on the basis of eligibility criteria mentioned earlier. A brief demographic data will be obtained and a written consent will be taken from all the included participants. Participants will be briefed about the study. There will be 180 number of participants The subject for the study was randomly allocated in to two equal groups (90 in each group). Group A gluteus maximus strengthening group and Group B gluteus medius strengthening group. Over the course of two weeks, each group will receive twelve sessions of treatmentsix sessions per week. Treatment would be provided to both groups in the same manner. Each session would require roughly the same amount of time. Group A: Gluteus maximus strengthening (3 sets of 15 repetition)-participants will perform exercises, involving active prone hip extension in different positions: Progression 1: knee flexion (KF) Progression 2: lateral hip rotation and knee extension (LHRKE) Progression 3: lateral hip rotation and knee flexion (LHR-KF) Group B: Gluteus maximus strengthening (3 sets of 15 repetition)- To strengthen the GMed muscle, the clamshell exercise was used. Since the foot is the initial structure of the body to interact with the floor, any weakness or injury to this component might affect how well an athlete performs. - Progression 1: To raise the top knee and return to the starting position, individuals externally rotated their top hip. - Progression 2: Participant internally rotated the upper hip while maintaining their knees together, and then they reverted to their initial posture. - Progression 3: Before resuming the initial position, participants elevated their upper thighs parallel to the floor and raised their feet towards the ceiling, forcing their hips to internally spin. - Progression 4: With the upper hip completely extended, participants executed a similar exercise as in Progression 3. Foot exercises (common for both the group) Foot active range of motion exercises (3 sets of 15 repetitions) Foot curls (3 sets of 15 repetitions) Foot roller (3 sets of 15 repetitions) Calf raises (3 sets of 15 repetitions) |