| CTRI Number |
CTRI/2024/03/064403 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of a hip joint muscle(gluteus maximus) on pressure of foot |
|
Scientific Title of Study
|
Effect of Gluteus Maximus strengthening on foot pressure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garvari |
| Designation |
UG Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
8307121345 |
| Fax |
|
| Email |
garvarisawasthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Malik |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
malik_manoj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Manoj Malik |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
malik_manoj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Garvari |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Manoj Malik |
Department of Physiotherapy Guru Jambheshwar Universityr |
Room no. 5 Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA |
9896221262
garvarisawasthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUS&T |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gluteus Maximus weakness with grade 4 or less than 4 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gluteus maximus strengthening |
Subject will be given gluteus maximus strengthening 10 times 3 set for 3 days in a week on
alternate days for 4 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having gluteus maximus weakness on MMT grade 4 or less than 4 |
|
| ExclusionCriteria |
| Details |
Subjects with previous history of foot/ankle fractures/surgery.
Subjects with foot abnormalities.
Recent fractures or persistent disability in pelvis or lower limbs.
Subjects with system or orthopedic problems affecting lower limb such as diabetic
neuropathy, double vision, weakness or atrophy of lower limb muscles |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Foot pressure distribution |
The outcome will be assessed two times pre and post intervention i.e. after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
29/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Foot pressure is the pressure field that exists between the foot and the support surface during routine locomotor activity .The gluteus maximus becoming weaker results in the excess internal rotation of the hip joint and pronation of the foot. Re-establishing proper muscle recruitment patterns and improving strength and performance can be achieved by reactivating the gluteal maximus. From this study I want to examine how the gluteus maximus strength is affecting the foot pressure distribution. In this study, I will recruit subjects randomly and will give intervention and check if strengthening is affecting the foot pressure distribution or not. |