| CTRI Number |
CTRI/2022/02/039949 [Registered on: 02/02/2022] Trial Registered Prospectively |
| Last Modified On: |
29/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
3D Gait Analysis in Healthy Young Adults |
|
Scientific Title of Study
|
Correlation of 3D Gait Analysis with Physical Activity in Healthy Individuals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kajal Chheda |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Sunandan Divatia School of Science, NMIMS university |
| Address |
Department of Physiotherapy
Ground Floor
Nanavati Super Speciality Hospital
SV Road
Vile Parle West
Mumbai
Department of Physiotherapy
Ground Floor
Nanavati Super Speciality Hospital
SV Road
Vile Parle West
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9819644848 |
| Fax |
|
| Email |
kajalchheda602@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Poonam Parulekar |
| Designation |
Assistant Professor |
| Affiliation |
Sunandan Divatia School of Science, NMIMS university |
| Address |
Department of Physiotherapy
Ground Floor
Nanavati Super Speciality Hospital
SV Road
Vile Parle West
Mumbai
Department of Physiotherapy
Ground Floor
Nanavati Super Speciality Hospital
SV Road
Vile Parle West
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9821820233 |
| Fax |
|
| Email |
poonam.parulekar@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kajal Chheda |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Sunandan Divatia School of Science, NMIMS university |
| Address |
Department of Physiotherapy
Ground Floor
Nanavati Super Speciality Hospital
SV Road
Vile Parle West
Mumbai
Department of Physiotherapy
Ground Floor
Nanavati Super Speciality Hospital
SV Road
Vile Parle West
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9819644848 |
| Fax |
|
| Email |
kajalchheda602@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
none |
| Address |
NIL |
| 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 Superspecialty Hospital |
Department of Physiotherapy
Ground Floor
Nanavati Superspeciality Hospital
SV road
Vile Parle West
Mumbai 400056
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
|
| Type |
Name |
Details |
| Comparator Agent |
Basic Details
Gait Parameteres |
Subject
Age,Height,Weight,BMI
Speed, Stride Length, Step Widht, Step Lenth, Cadence
Initial, Mid Stance
Initial , Mid Swing of Hip, Knee and Ankle in Sagittal, Coronal Plane
Hip Rotations in Transverse Plane
IPAQ Score
Sit And Reach Table Test |
|
|
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 or Orthopedic conditions such as
Recent Lower Limb Fractures within 6 months
Recent Spinal Fractures within 6 months
Soft Tissue injuries like Ankle Sprain
Active Systemic Diseases affecting normal gait in subjects |
|
|
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
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
International Physical Activity Questionnaires IPAQ Score
Sit And Reach Test |
One Time
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
10/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/02/2022 |
| 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
|
TITLE :-NORMATIVE DATA OF 3D GAIT ANALYSIS & ASSESSING ITS RELATIONSHIP WITH PHYSICAL ACTIVITY IN HEALTHY YOUNG ADULTS.
INTRODUCTION :-
Locomotion or Gait is defined as a translatory progression of the body as a whole produced by coordinated, rotatory movements of the body segments.
Normal Gait is rhythmic and characterised by alternating propulsive & retro-pulsive motions of the lower extremities. Many people can move about with abnormal or asymmetrical gait patterns for years without any symptoms. However, when someone experiences an injury or pain, normal gait can be altered, resulting in abnormal walking that can lead to bigger health issues. This is why gait analysis is important.
Moreover, there is a lack of literature stating about the Normative data of Gait Patterns seen in Health Young Adults across the Indian population. Therefore, this study aims to establish a Normative Data for Gait Patterns seen in Healthy Young Adults (18-25 years) across the Indian Population and additionally, determine if there exists any relationship between Gait Biomechanics and Physical Activity levels and Muscle Length. Earlier gait analysis used Cinematographic films, Electrogoniometres and Electromyography. Although converting those signals into force values was a major limitation of its use. However, an explosion in the technical advancements brought in a Modern Gait Laboratory which includes motion analysis system employing precise marker location over several body segments which has provided comprehensive information about limb position and their motions in Normal and Abnormal gait.
AIM: To establish Normative Data of 3D gait analysis for Indian population and assessing its relationship with physical activity in Healthy Young Adults. OBJECTIVES: 1) To establish/ find Normative Data of 3D gait analysis for Indian population. 2) To correlate 3D gait analysis with Physical Activity level in Healthy Young Adults. 3) To correlate 3D gait analysis with Muscle Length in Healthy Young Adults.
| INCLUSION CRITERIA | EXCLUSION CRITERIA | | Healthy Young Adults (18-25years) | Any Musculoskeletal or Orthopaedic conditions, such as recent Lower Limb or Spinal fractures Soft tissue injuries; Active Systemic Disease which can affect Normal gait patterns in the subjects. | | | |
|