| CTRI Number |
CTRI/2023/11/059479 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
29/10/2023 |
| 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
|
Foot and Core Muscles Strengthening effect On Balance and foot Pressure Among Recreational Football Players With Pes Planus:RANDOMIZED CONTROLLED TRIAL |
|
Scientific Title of Study
|
Effect Of Foot and Core Muscles Strengthening On Dynamic Balance and Center Of Pressure Among Recreational Football Players With Pes Planus: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 |
RATHOD NISHABA DASHRATHSINH |
| Designation |
PG STUDENT |
| Affiliation |
Institute of physiotherapy, Srinivas University |
| Address |
Orthopedic department, Institute of physiotherapy, City campus, Srinivas University, Pandeshwar,Mangaluru,India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7203986900 |
| Fax |
|
| Email |
rathodnishaba21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. MADHURIPU P |
| Designation |
Assistant professor |
| Affiliation |
Institute of physiotherapy, Srinivas University |
| Address |
Orthopedic department Institute of physiotherapy, City campus, Srinivas University, Pandeshwar,Mangaluru,India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9446292852 |
| Fax |
|
| Email |
madhuripu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RATHOD NISHABA DASHRATHSINH |
| Designation |
PG STUDENT |
| Affiliation |
Institute of physiotherapy, Srinivas University |
| Address |
Orthopedic department Institute of physiotherapy, City campus, Srinivas University, Pandeshwar,Mangaluru,India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7203986900 |
| Fax |
|
| Email |
rathodnishaba21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rathod Nishaba
Orthopedic department
srinivas institute of physiotherapy,Pandeshwar,Mangalore |
|
|
Primary Sponsor
|
| Name |
Rathod Nishaba Dashrathsinh |
| Address |
Institute of physiotherapy, City campus, Srinivas University,Pandeshwar, Mangaluru, India |
| 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 |
| Rathod Nishaba |
Srinivas institute of physiotherapy |
Orthopedic department,Srinivas Institute of physiotherapy, City campus, Srinivas University, Pandeshwar,Mangaluru,India
Dakshina Kannada
KARNATAKA |
7203986900
rathodnishaba21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas University Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Recreational Football Player With Pes Planus |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Intrinsic and Extrinsic Foot muscles strengthening
2.Core muscles strengthening |
1.Foot muscles strengthening Resisted exercise of foot adduction,supination,dorsiflexion, inversion, eversion with using green, blue ,black and silver color theraband progressively
toe curl exercise in sitting position in progression standing.
Heel rise bilateral progressively one leg standing heel raise.All these exercise 10 repetation 3 sets
2.core muscle strengthening
Bridging,Curl up 1 & 2
Back extension 1 & 2
Front and side plank
Birddog (30 second hold 3 set)
5 days in week for 2 months |
| Comparator Agent |
Intrinsic and Extrinsic Foot Muscles strengthening Exercise |
Resisted exercise of foot adduction,supination,dorsiflexion, inversion, eversion with using green, blue ,black and silver color theraband progressively toe curl exercise in sitting position in progression standing. Heel rise bilateral progressively one leg standing heel raise.All these exercise 10 repetation 3 sets
(5 days in a week for 2 months) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
Flexible flat foot
Playing football 1 hour twice a week
Recreational football players who played sports recreationally in a place where they lived
Arch index >0.2626
BMI between 18 to 24
|
|
| ExclusionCriteria |
| Details |
Lower extremity surgery within a year
Flexible flatfoot with neuromuscular involvement.
Congenital foot abnormality
Limb length discrepancy
Pes cavus
•Low back pain19
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Y balance test lower quadrant
Bertac force platform |
Base line and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/11/2023 |
| 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 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
|
Effect of foot and core muscles strengthening on dynamic balance and center of pressure among recreational football players with pes planus - Randomized controlled Trial got ethical approval from srinivas University. The purpose of study is to identify the effect of muscle strengthening in football player to improve balance and reduce injuries.Because who is playing foot recreationally they got injured very oftenly due to lack of trainning and exercise. |