| CTRI Number |
CTRI/2021/11/037729 [Registered on: 01/11/2021] Trial Registered Prospectively |
| Last Modified On: |
30/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of trunk muscle strength and fatigability in young adults with faulty neck posture. |
|
Scientific Title of Study
|
Correlation of lumbar core muscle strength and endurance with severity of forward head posture in young adults. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharati Asgaonkar |
| Designation |
Associate Professor |
| Affiliation |
Topiwala National Medical College and BYL Nair Ch Hospital |
| Address |
Physiotherapy School and Centre Topiwala National Medical College and BYL Nair Ch Hospital Mumbai Central Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9987103028 |
| Fax |
|
| Email |
bharatiasgaonkar@tnmcnair.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharati Asgaonkar |
| Designation |
Associate Professor |
| Affiliation |
Topiwala National Medical College and BYL Nair Ch Hospital |
| Address |
Physiotherapy School and Centre Topiwala National Medical College and BYL Nair Ch Hospital Mumbai Central Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9987103028 |
| Fax |
|
| Email |
bharatiasgaonkar@tnmcnair.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Samiksha Moharkar |
| Designation |
Post Graduate Student |
| Affiliation |
Topiwala National Medical College and BYL Nair Ch Hospital |
| Address |
Physiotherapy School and Centre Topiwala National Medical College and BYL Nair Ch Hospital Mumbai Central Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7208119845 |
| Fax |
|
| Email |
moharkarsamiksha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Physiotherapy School and Centre Topiwala National Medical College and BYL Nair Ch Hospital |
| Address |
Physiotherapy School and Centre Topiwala National Medical College and BYL Nair Ch Hospital Mumbai Central Mumbai 400008 |
| Type of Sponsor |
Government medical college |
|
|
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 Bharati Asgaonkar |
Physiotherapy School and Centre, Topiwala National Medical College and BYL Nair Charitable Hospital |
Physiotherapy School and Centre Topiwala National Medical College and BYL Nair Ch Hospital Mumbai Central Mumbai 400008
Mumbai
MAHARASHTRA |
9987103028
bharatiasgaonkar@tnmcnair.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee For Academic Research Projects (ECARP), PG Academic Committee, TNMC and BYL Nair Ch Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
forward head posture |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) individuals having forward head posture (both symptomatic and asymptomatic.) [CVA<48 degrees]
2) individuals with normal BMI (18.5- 24.9 kg/m square)
3) individuals willing to participate. |
|
| ExclusionCriteria |
| Details |
1) history of neurological, orthopaedic and cardiopulmonary disease.
2) doing professional sport.
3) individuals with spinal deformities.
4) symptomatic low back pain.
5) any recent fractures.
6) congenital or acquired chest wall deformity. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) lumbar core flexor strength.
2) lumbar core extensor strength.
3) biering sorensen test.
4) trunk flexor endurance test.
5) side bridge test (left and right)
6) prone double straight leg raise test. |
One time assessment of patients will be done with total duration of assessment not exceeding 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/11/2021 |
| 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 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)?
Response - NO
|
|
Brief Summary
|
This study is an observational, cross sectional study to find out correlation between lumbar core muscle strength and endurance with that of severity of forward head posture in young adults. The lumbar core muscle strength will be measured using hand dynamometer and the lumbar core muscle endurance will be measured using Biering Sorensen test, trunk flexor endurance test, side bridge test (left and right), prone double straight leg raise test. |