| CTRI Number |
CTRI/2020/03/024362 [Registered on: 30/03/2020] Trial Registered Prospectively |
| Last Modified On: |
29/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy Of Customized Foot Insoles In Athletes With Anterior Knee Pain And Flat Foot |
|
Scientific Title of Study
|
Efficacy Of Customized Foot Insoles In Athletes With Patellofemoral Pain Syndrome And Pronated Feet |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surbhi |
| Designation |
Post Graduation student |
| Affiliation |
ISIC institute of Rehabilitation Sciences |
| Address |
Prosthetics and Orthotics departmnet, basement,Indian Spinal Injuries Centre Sector C, Vasant Kunj, Opp. Vasant Valley School, New Delhi, 110070
Prosthetics and Orthotics departmnet, basement,Indian Spinal Injuries Centre Sector C, Vasant Kunj, Opp. Vasant Valley School, New Delhi, 110070
South West
DELHI
110070
India |
| Phone |
9034766462 |
| Fax |
|
| Email |
surbhinandal88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yashika Kumar |
| Designation |
Assistant Professor |
| Affiliation |
ISIC institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre Sector C, Vasant Kunj, Opp. Vasant Valley School, New Delhi, 110070
Indian Spinal Injuries Centre Sector C, Vasant Kunj, Opp. Vasant Valley School, New Delhi, 110070
South
DELHI
110070
India |
| Phone |
9711995994 |
| Fax |
|
| Email |
yashikakumar28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surbhi |
| Designation |
Post Graduation student |
| Affiliation |
ISIC institute of Rehabilitation Sciences |
| Address |
Prosthetics and Orthotics Departmentt,Basement, Indian Spinal Injuries Centre Sector C, Vasant Kunj, Opp. Vasant Valley School, New Delhi, 110070
Prosthetics and Orthotics Department, Basement, Indian Spinal Injuries Centre Sector C, Vasant Kunj, Opp. Vasant Valley School, New Delhi, 110070
South
DELHI
110070
India |
| Phone |
9034766462 |
| Fax |
|
| Email |
surbhinandal88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre, Vasant Kunj, Secotr C, New Delhi 110070 |
|
|
Primary Sponsor
|
| Name |
Surbhi |
| Address |
ISIC, institute of REhabilitation Sciences vasant kunj, sctor c, 110070 |
| Type of Sponsor |
Other [none] |
|
|
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 |
| Surbhi |
ISIC Institute of Rehabilitation Sciences |
Prosthetics and Orthotics department, basement,ISIC Institute of Rehabilitation Sciences, vasnat kunj, sector c, 110070
South
DELHI |
09034766462
surbhinandal88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M222||Patellofemoral disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Customized Foot Insole |
It is a device that is used as an interface between the foot and shoe which includes a medial arch support that will indirectly supports the talus and navicular bones of foot and gives resilient support to the longitudinal arch of foot and tends to maintain the bones of the longitudinal arch in normal alignment. The customized foot insole that will be used in this study will be made up of a combination of 3 materials as EVA will be used as a base layer as it will be stiff enough to provide stability to the patient as it is more resilient and less compressible. Arch support for stimulation of mechanoreceptors will be help in increasing the proprioception that will be made by sponge rubber (MCR) and Multifoam as the top adaption layer which will be in contact with foot. It is low density, more resilient and least compressible under repeated impact. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 20- 30 years
2. Subjects with knee pain from at least 2 months
3. Subject having bilateral pronated feet
• Navicular foot drop index is greater than 10 mm
4. Patellar compression test should be positive
5. VAS score- 3 to 7(mild to moderate)
6. Subject who gave informed consent to participate in the study
7. Subject having no history for the use of foot orthotic
8. Subjects who are not visually and hearing deficit
9. BMI range between 18– 25
|
|
| ExclusionCriteria |
| Details |
1. Histories of knee ligament or meniscal injury, patellar dislocation or subluxation.
2. Leg length discrepancy more than1cm
3. Known pathological or neurological disorders that could affect gait pattern.
4. Regular medication for the running related symptoms.
5. Acute trauma history within one year
6. Drug use affecting muscle strength
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain(VAS), balance(MINIBEST), energy consumption(PCI) |
after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/04/2020 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a single arm trial calculating the effects of
custom-molded insoles on pain, balance, and energy expenditure in 45 patients
with patellofemoral knee syndrome and flat foot at Indian Spinal Injuries
Center in New Delhi. The primary outcome measures will be Vas scale for pain,
MINIBest test for balance and Physiological Cost Index of walking for energy
expenditure, all of which will be calculated 2 weeks after baseline assessment.
|