| CTRI Number |
CTRI/2021/10/037586 [Registered on: 26/10/2021] Trial Registered Prospectively |
| Last Modified On: |
26/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The study of Simple Reaction Time and Cervical Joint Position sense in Young adults with no symptoms having Forward Head Posture (FHP) |
|
Scientific Title of Study
|
Correlation between the Simple Reaction Time and Cervical Proprioception in Asymptomatic Young Adults With Forward Head Posture(FHP)- A Cross Sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECARP/2021/60 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati V Kubal |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy School and Center TNMC and BYL Nair Charitable Hospital Mumbai |
| Address |
Physiotherapy School and Center TNMC and BYL Nair Charitable Hospital Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027503 |
| Fax |
|
| Email |
Swatikubal@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhagyashree Medhekar |
| Designation |
Postgraduate student |
| Affiliation |
Physiotherapy School and Center TNMC and BYL Nair Charitable Hospital Mumbai |
| Address |
Physiotherapy School and Center TNMC and BYL Nair Charitable Hospital Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8097830162 |
| Fax |
|
| Email |
bhagyashreemedhekar06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhagyashree Medhekar |
| Designation |
Postgraduate student |
| Affiliation |
Physiotherapy School and Center TNMC and BYL Nair Charitable Hospital Mumbai |
| Address |
Physiotherapy School and Center TNMC and BYL Nair Charitable Hospital Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8097830162 |
| Fax |
|
| Email |
bhagyashreemedhekar06@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Physiotherapy School and Center |
| Address |
Physiotherapy school and center TNMC and BYL Nair Charitable Hospital Mumbai |
| 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 |
| DrSwati Kubal |
Physiotherapy School and center |
Opd no 24, Physiotherapy Opd, Physiotherapy School and Center, TNMC and BYL Nair Charitable Hospital Mumbai
Mumbai
MAHARASHTRA |
02223027503
Swatikubal@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for academic research projects ( ECARP) PG academic committee, TN Medical college and BYL Nair Ch Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy young adults with forward head posture |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Young adults 18-30 years
Forward Head Posture CVA: <49 degree
Both gender
Normal corrected vision |
|
| ExclusionCriteria |
| Details |
History of any Musculoskeletal, Neurological and Cardiopulmonary conditions
Cervical spine instability
Trauma to cervical spine
Cervical spine surgery
Congenital spinal deformities
Patients with impaired cognition
Vertigo
Impaired vision |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Cervicocephalic Relocation Test (CRT) for measuring Cervical Proprioception
2.Deary-liewald Time Task for measuring Simple Reaction Time (SRT) |
One time assesment of patients will be done with total duration of assesment not exceeding 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
28/10/2021 |
| 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 correlate between the simple reaction time and cervical proprioception in Asymptomatic Young adults with Forward Head Posture (FHP)The craniovertebral angle will be measured using ON Protractor mobile application which should be less than 49degress to be considered as Forward Head Posture The outcome measure that will be used to measure the cervical proprioception is Cervicocephalic Relocation test(CRT) and for measuring Simple Reaction Time is Deary-Liewald Time Task. |