| CTRI Number |
CTRI/2024/06/068912 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association between changes in posture and forward movement among healthy individuals by using plantar pressure device in sit to stand |
|
Scientific Title of Study
|
Influence of altered postures on forward continuation, plantar pressure in sit to stand among asymptomatic individuals: A correlation study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bethany Fernandes |
| Designation |
Post graduate student |
| Affiliation |
Nitte Deemed to be University |
| Address |
Department of Physiotherapy, Room no-20,Second base division, NITTE Institute of Physiotherapy,NITTE [Deemed to be University],Deralakatte,Mangalore, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8180028441 |
| Fax |
|
| Email |
bethanyesther@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Nityal Kumar Alagingi |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Deemed to be University |
| Address |
Department of Physiotherapy, Room no-20,Second base division, NITTE Institute of Physiotherapy,NITTE [Deemed to be University],Deralakatte,Mangalore, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Nityal Kumar Alagingi |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Deemed to be University |
| Address |
Department of Physiotherapy, Room no-20,Second base division, NITTE Institute of Physiotherapy,NITTE [Deemed to be University],Deralakatte,Mangalore, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Room no-20,Second base division, NITTE Institute of Physiotherapy,NITTE [Deemed to be University],Deralakatte,Mangalore, Karnataka,575018,India |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy Nitte Deemed to be University |
| Address |
Department of Physiotherapy, Room no-20, Second based division,Nitte Institute of Physiotherapy, Nitte Deemed to be University,Deralakatte,Mangalaru,Karnataka,575018,India |
| Type of Sponsor |
Other [Nitte Institute of Physiotherapy, Nitte Deemed to be University] |
|
|
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 |
| Dr Nityal Kumar Alagingi |
Nitte Institute of Physiotherapy[Nitte Deemed to be University] |
Department of Physiotherapy, Room no-20,Second base division, NITTE Institute of Physiotherapy,NITTE [Deemed to be University],Deralakatte,Mangalore, Karnataka,575018, India
Dakshina Kannada
KARNATAKA |
8180028441
bethanyesther@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Nitte Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
College students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Students recruited from Nitte Institute of Physiotherapy
2. Males and females of 19 to 25 years of age
3. Students who have deviations in posture which is analysed by using posture grid analysis as per shift from line of gravity which is measured in centimetres |
|
| ExclusionCriteria |
| Details |
1. Any recent illness
2. Any low back pain, neck pain
3. presence of neurological signs (e.g., perceived weakness in the lower limbs)
4. Any history of fracture
5. Lower limb length discrepancies |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trunk Inclination angle through Kinovea app |
The outcome measure used for the observational study which is the Trunk Inclination angle through Kinovea app will be taken on the same day while recruiting the samples. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plantar pressure by using Ohm 3000 app |
Plantar pressure by using Ohm 3000 app will be used on the same day after recruitment of samples as it is an observational study. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
17/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Posture is very important in day to day life in an individual. Human posture has been shown to alter with time, usually beginning at school age, due to body growth and development. The change in biomechanical alignment of neck, shoulder and lumbar spine which will affect the individual’s posture which causes changes in the foot region. Thus, there is a need to identify the changes coming from the foot region as this will be helpful for knowing early changes in posture and foot which inturn benefits the musculoskeletal health especially in young adults. In asymptomatic individuals with no pain who have altered postures, their forward propulsion will get affected and COG will shift from base of support which will further lead to changes in plantar pressure and trunk angles. Plantar pressure is an essential tool which is used to assess percentages of pressure in both the feet and trunk angles can be assessed by using Kinovea app in sit to stand. Since, there are limited studies which are done by using plantar pressure and trunk angle as key components to observe for changes in posture in asymptomatic individuals. Therefore, this study is to identify in asymptomatic individuals whether postural changes causes changes in plantar pressure and trunk angles during sit to stand. |