| CTRI Number |
CTRI/2025/03/083708 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| 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
|
Effects of Short Foot Exercise with Conventional Physiotherapy on Foot Posture, Balance and Function in Knee Osteoarthritis Patients with Flatfoot : A Randomised Controlled Trial |
|
Scientific Title of Study
|
Effects of Short Foot Exercise with Conventional Physiotherapy on Foot Posture, Balance and Function in Knee Osteoarthritis Patients with 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 |
Nikita Jayaprakash |
| Designation |
Physiotherapist |
| Affiliation |
D Y Patil University, School of Physiotherapy, Nerul, Navi Mumbai |
| Address |
D.Y Patil University School of Physiotherapy, Sri Chandrasekarendra saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagar , Sector 5, Nerul, Navi Mumbai Maharashtra, 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
8097807530 |
| Fax |
|
| Email |
nikita1998jp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shellette D Almeida |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil University, School of Physiotherapy, Nerul, Navi Mumbai |
| Address |
D.Y Patil University School of Physiotherapy, Sri Chandrasekarendra saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagar , Sector 5, Nerul, Navi Mumbai Maharashtra, 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
8073899826 |
| Fax |
|
| Email |
shellette.almeida@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Jayaprakash |
| Designation |
Physiotherapist |
| Affiliation |
D Y Patil University, School of Physiotherapy, Nerul, Navi Mumbai |
| Address |
D.Y Patil University School of Physiotherapy, Sri Chandrasekarendra saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagar , Sector 5, Nerul, Navi Mumbai Maharashtra, 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
8097807530 |
| Fax |
|
| Email |
nikita1998jp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nikita Jayaprakash |
| Address |
601 - Harbour Court, Plot no 49/3, Sector 19A, Nerul, Navi Mumbai, Maharashtra, 400706 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shellette D Almeida |
D.Y Patil University School of Physiotherapy, Sri Chandrasekarendra saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagar , Sector 5, Nerul, Navi Mumbai Maharashtra, 400706 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikita Jayaprakash |
D Y Patil University |
601- Harbour Court, Plot no. 49/3, Sector 19A, Nerul, Navi Mumbai, Maharashtra, 400706
Thane
MAHARASHTRA |
8097807530
nikita1998jp@gmail.com |
| Dr Shellette D Almeida |
D Y Patil University |
D.Y Patil University School of Physiotherapy, Sri Chandrasekarendra saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagar , Sector 5, Nerul, Navi Mumbai Maharashtra, 400706
Thane
MAHARASHTRA |
8073899826
shellette.almeida@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| D Y Patil Institutional Ethics Committe For Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Conventional exercises with Short Foot Exercises |
Group A: Conventional exercises with Short Foot Exercises. the patients in this group will receive progressive resistance training, stretching exercises, soft tissue manipulation. MET, Maitland mobilisation along with Short Foot exercises with 10 reps for 3 sets progressing over 4 weeks. |
| Comparator Agent |
Group B: Conventional Physiotherapy Protocol |
Group B: Conventional Physiotherapy Protocol.
the patients in this group will receive progressive resistance training, stretching exercises, soft tissue manipulation. MET, Maitland mobilisation along with conventional foot exercises with 10 reps for 3 sets progressing over 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
Patients with diagnosed case of grade 2 or grade 3 knee OA on Kellgren and Lawrence grading referred by orthopedic to physiotherapy department
Overpronated foot with a navicular drop test score of more than 10mm
VAS less than or equal to 7
Y Balance test composite score below 80%
Foot posture index score above +5 |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
Recent history of lower limb fractures
Recent / past history of any kind surgery of lower limb
History of ligament or meniscal injury, rheumatoid arthritis, deformities
Visual or vestibular impairment
Any neurological or vascular deficit affecting balance |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Foot posture index
WOMAC scale
Navicular drop test |
Patients will assessed at baseline and after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Y balance test
Visual Analog Scale (VAS) |
Patients will assessed at baseline and after 4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="16"
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)
|
24/04/2025 |
| 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
|
Knee osteoarthritis (OA) impairs mobility and is worsened by flatfoot, causing postural imbalances. Research shows foot posture affects lower limb mechanics. Short foot exercises, designed to strengthen foot muscles and improve arch support, may help improve balance and function. This study examines their effects on foot posture, balance, and function in knee OA patients with flatfoot. |