| CTRI Number |
CTRI/2024/09/073286 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Correlational |
| Study Design |
Other |
|
Public Title of Study
|
Comparing posture with ability to perform hand function effectively |
|
Scientific Title of Study
|
Correlation Between Craniovertebral Angle and Dynamic Hand Grip Endurance Among Physiotherapy Students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aadhya Aggarwal |
| Designation |
Student |
| Affiliation |
SRM College of Physiotherapy, SRMIST |
| Address |
SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram TAMIL NADU 603203 India |
| Phone |
9582194931 |
| Fax |
|
| Email |
aa2759@srmist.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Divya Varshini R |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy, SRMIST |
| Address |
SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur
TAMIL NADU 603203 India |
| Phone |
8526764010 |
| Fax |
|
| Email |
divyavar@srmist.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Aadhya Aggarwal |
| Designation |
Student |
| Affiliation |
SRM College of Physiotherapy, SRMIST |
| Address |
SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur
TAMIL NADU 603203 India |
| Phone |
9582194931 |
| Fax |
|
| Email |
aa2759@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, SRMIST, Kattankulathur, Chennai, Tamil Nadu-603203 (Infrastructural support) |
|
|
Primary Sponsor
|
| Name |
Aadhya Aggarwal |
| Address |
SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Aadhya Aggarwal |
SRM College of Physiotherapy |
Department of Physiotherapy, 4th floor, SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur Kancheepuram TAMIL NADU |
9582194931
aa2759@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Craniovertebral Angle and Dynamic Hand grip endurance- Biomechanical aspects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
SRM College of Physiotherapy students
Comfortable with photographic evaluation |
|
| ExclusionCriteria |
| Details |
Presence of any pain in head, neck, or upper limb
History of musculoskeletal injury around head, neck, or hand
Neurological conditions of upper limb
Participation in specific training programs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CV Angle using photo with MB Ruler Software. Measured in degrees. Continuous data |
Baseline evaluation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dynamic Hand Grip Endurance measured using Dynamometer |
Baseline evaluation |
|
|
Target Sample Size
|
Total Sample Size="82" Sample Size from India="82"
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)
|
04/09/2024 |
| 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="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The study was approved by Institutional Ethical Committee [IEC]-Ethical Clearance Number: SRMIEC-ST0224-1121 of SRM Medical College Hospital and Research Centre. The participants
will be selected according to the inclusion criteria and will be informed about
the study. The informed
consent will be obtained from the participants. The participants
will be made to sit comfortably in a chair with feet on ground and hands on
their lap. The neck will be passively flexed and extended to palpate the C7
spinous process as it remains stable during movement. A marker will be used to
mark the C7 process and tragus of ear. The camera will be
supported on tripod and placed such that the markers are visible in a single
image. A lateral image will be taken for measuring the CV angle. The picture
will then be transferred to laptop via data cable and MB Ruler Software will be
used to evaluate the CV angle. Grip endurance
will be measured using dynamometer. The participants will be seated in upright
position with shoulder at 0° abduction, elbow flexed at 90° flexion, forearm in
neutral position and wrist at 0-30° extension. The arm will be positioned on a
table for support.12 consecutive
maximal contractions will be done by the dominant hand. Contractions will be
held for 3 seconds with 5 second rest period between repetitions. Endurance will be
calculated using the fatigue index and percentage
change. Collected data
will undergo appropriate statistical analysis to draw meaningful
conclusions |