| CTRI Number |
CTRI/2024/08/071990 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of pelvic width to pelvic movements during walking. |
|
Scientific Title of Study
|
Correlation of Pelvic Width to Pelvic Kinematics during 3D Gait- An Observational 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 |
Dr Varsha Huddar |
| Designation |
Assistant Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
2nd floor, Staff Room, KLE INSTITUTE OF PHYSIOTHERAPY, NEHRU NAGAR, BELGAVI- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7892677707 |
| Fax |
|
| Email |
varshahuddar@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahima Sisodia |
| Designation |
PG Student |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
2nd floor, Office, KLE INSTITUTE OF PHYSIOTHERAPY, NEHRU NAGAR, BELGAVI- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
07300003067 |
| Fax |
|
| Email |
mahima99.jdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahima Sisodia |
| Designation |
PG Student |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
2nd floor, office, KLE INSTITUTE OF PHYSIOTHERAPY, NEHRU NAGAR, BELGAVI- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
07300003067 |
| Fax |
|
| Email |
mahima99.jdr@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Institute of Physiotherapy, Nehru Nagar, Belagavi- 590010, Karnataka |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
KLE Institute of physiotherapy, Nehru Nagar, Belagavi- 590010 |
| 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 |
| Dr Varsha Huddar |
Dr. Prabhakar Kore Hospital |
Physiotherapy OPD (OPD No. 39), Floor- basement (G-1), Dr. Prabhakar KORE Hospital, NEHRU NAGAR, BELGAVI- 590010
Belgaum
KARNATAKA |
09880733370
varshahuddar@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Research and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
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 |
Female |
| Details |
Age- 18 to 25 years
Gender- both male and female
Normal BMI
|
|
| ExclusionCriteria |
| Details |
Any current or previous injury in lower limb or pelvis past one year
Any surgery in lower limb or pelvis which could affect the gait
Any existing postural deformity
Diagnosed orthopedic or neurological condition which could affect pelvic movements.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
3D Gait Analysis
Pelvimeter |
only one time at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
19/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
An exploratory study will be conducted to determine correlation between pelvic width and pelvic kinematics during gait in healthy volunteers of aged from 18to 25 years. The outcome measure used will be pelvimeter to measure pelvic width and BTS Engineering gait lab to assess pelvic kinematics in all planes i.e. sagittal, frontal, transverse. |