| CTRI Number |
CTRI/2022/02/040154 [Registered on: 09/02/2022] Trial Registered Prospectively |
| Last Modified On: |
10/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of muscle performance in good and poor posture |
|
Scientific Title of Study
|
The comparison of cranio-cervical flexion test performance in individuals with and without forward head posture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ganesh Balthillaya M |
| Designation |
Assistant Professor- Selection grade |
| Affiliation |
MAHE, Manipal |
| Address |
Department of Physiotherapy
MCHP, Manipal Academy of Higher education, Manipal
Manipal ,Udupi, Karnataka
Udupi
KARNATAKA
576107
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Balthillaya M |
| Designation |
Assistant Professor- Selection grade |
| Affiliation |
MAHE, Manipal |
| Address |
Department of Physiotherapy
MCHP, Manipal Academy of Higher education, Manipal
Manipal ,Udupi, Karnataka
KARNATAKA
576107
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh Balthillaya M |
| Designation |
Assistant Professor- Selection grade |
| Affiliation |
MAHE, Manipal |
| Address |
Department of Physiotherapy
MCHP, Manipal Academy of Higher education, Manipal
Manipal ,Udupi, Karnataka
KARNATAKA
576107
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal college of Health Professions, MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
MCHP Manipal |
| Address |
MCHP, MAHE, Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ganesh Balthillaya M |
Manipal college of Health professions. |
Department of Physiotherapy, Room no-1,
Udupi
KARNATAKA |
9448263631
ganesh.bm@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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 |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age - 20- 50 years
2. Gender- either of the gender without any cervical pathology
3. For participants with forward head posture with forward head angle with ≥46 ͦ
|
|
| ExclusionCriteria |
| Details |
1. History of neck pain
2. Undergone any head and neck surgery
3. Nerve injuries, Frequent headaches, previous
cervical spine trauma
4. History of any medical or surgical conditions of neck
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cranio-cervical flexion test activation score, Performance index,higest pressure score |
out come assed at one time point at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nill |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2022 |
| Date of Study Completion (India) |
10/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
May be published after completion of the project |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Forward head posture is one of the commonly recognized types of poor head posture. Forward head posture is one of the contributing factor for the development of neck pain. Deep cervical flexor muscles play an important role in stabilizing joints of neck and preventing stress on structures of neck. Cranio-cervical flexion test is used score the performance of deep cervical flexor muscles. Influence of upper back posture and neck posture on cranio-cervical flexion test performance have not been studied. Objective of the study is to compare and find the influence of forward head posture in cranio-cervical flexion test using pressure biofeedback unit, And hypothesis of the study is that cranio-cervical test performance will be poor in people with forward head posture when compared with ideal posture. |