| CTRI Number |
CTRI/2022/12/048518 [Registered on: 27/12/2022] Trial Registered Prospectively |
| Last Modified On: |
26/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Normatives |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To correlate the joint angles and orientation of lower limb during walking in adults with different foot arch.
|
|
Scientific Title of Study
|
Correlation of foot arch with lower extremity gait kinematics in healthy adults. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Julia Jossy |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Sunandan Divatia School of Science , NMIMS University |
| Address |
Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital, SV Road, Vile Parle West, Mumbai 400056
Bhaktivedanta Road
Mumbai (Suburban)
MAHARASHTRA
400056
India
Mumbai
MAHARASHTRA
400056
India |
| Phone |
8692805238 |
| Fax |
|
| Email |
juliajossy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Parulekar |
| Designation |
Assistant Professor |
| Affiliation |
Sunandan Divatia School of Science, NMIMS University |
| Address |
Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital, SV Road, Vile Parle West, Mumbai 400056
Bhaktivedanta Road
Mumbai (Suburban)
MAHARASHTRA
400056
India
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9821820233 |
| Fax |
|
| Email |
Poonam.Parulekar@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Julia Jossy |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Sunandan Divatia School of Science, NMIMS University |
| Address |
Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital, SV Road, Vile Parle West, Mumbai 400056
Bhaktivedanta Road
Mumbai (Suburban)
MAHARASHTRA
400056
India
Mumbai
MAHARASHTRA
400056
India |
| Phone |
8692805238 |
| Fax |
|
| Email |
juliajossy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital, SV Road, Vile Parle West, Mumbai 400056 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| St Xaviers Gait Lab |
St Xaviers Gait Lab
Xavier Institute of Engineering
Raheja Hospital Marg
Mahim
Mumbai 400016 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poonam Parulekar |
Nanavati Max Super Speciality Hospital |
Department of Physiotherapy,Ground floor Nanavati super speciality hospital SV road ,vile parle(w)
Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA |
9821820233
Poonam.Parulekar@nmims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee , Dr. Balabhai Nanavati Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Young Adults |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Young Adults 18 to 25 years |
|
| ExclusionCriteria |
| Details |
Any musculoskeletal trauma or soft tissue injuries of the lower limb , neurological conditions within the past 6 months which can influence the normal gait pattern in participants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 3D Gait Analysis Result |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Foot posture Index
Navicular Drop Test |
One time |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
29/12/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
Foot posture is characterized by the external shape of the foot and is determined by alignment of bones of the foot and the location, size and mechanical properties of the soft tissue covering them. Variations in foot posture such as pes planus or pes cavus are thought to be an intrinsic factor for injury due to altered motion of the lower extremity. The different postures thus influence segments higher up in the kinetic chain and dynamic posture during gait. Gait analysis involves a systematic measurement, description and assessment of quantities that characterize human locomotion. It becomes a necessity to learn about the intricacies of gait patterns that would predict future outcomes.
Since there is a lack of literature of the effect of varied foot arches on lower extremity gait kinematics, this study aims to establish a baseline for gait patterns in healthy adults.
AIM:
To study the effects of foot arch on lower extremity gait kinematics.
OBJECTIVES:
1. To assess foot posture in healthy adults. 2. To procure lower extremity gait kinematics with force plate analysis of healthy adults. 3. To correlate 3D gait analysis with foot posture in healthy adults.
INCLUSION CRITERIA:
Healthy adults in the age group of 18-25 years
EXCLUSION CRITERIA:
Any musculoskeletal trauma or soft tissue injury of the lower limb, neurological conditions within the past 6 months which can influence the normal gait pattern in participants
|