| CTRI Number |
CTRI/2020/01/022757 [Registered on: 14/01/2020] Trial Registered Prospectively |
| Last Modified On: |
12/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of muscle activity on upper one-third of thigh bone during weight bearing and non- weight bearing standing. |
|
Scientific Title of Study
|
Difference in proximal femur loading due to muscle activity during partial weight bearing and non-weight bearing standing- a cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smital Kshirsagar |
| Designation |
post graduate |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy Center for basic science kasturba Medical College
Bejai
Mangaluru
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
79722124884 |
| Fax |
|
| Email |
smital.kshir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish John Prabhakar |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy Center for basic science kasturba Medical College
Bejai
Mangaluru
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ashish John Prabhakar |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy Center for basic science kasturba Medical College
Bejai
Mangaluru
KARNATAKA
575003
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy
Kasturba Medical College |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Kasturba Medical College Hospital
Ambedkar Circle
Mangaluru |
| Type of Sponsor |
Private 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 |
| Smital Kshirsagar |
Kasturba Medical College Hospital |
Department of Physiotherapy Kasturba Medical College
Bejai
Mangaluru
Dakshina Kannada
KARNATAKA |
79722124884
smital.kshir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
normal individual |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy individuals |
|
| ExclusionCriteria |
| Details |
Current history of musculoskeletal injury, recent fracture in upper or lower limb
Abnormal gait pattern (due to any congenital deformities or discrepancy) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Data LITE wireless system of surface electromyography
- Peak muscle activity of each muscle |
at the time of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2020 |
| Date of Study Completion (India) |
04/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Incidence of proximal femur fractures is very high.
After surgical fixation of fracture rehabilitation for returning to function is
very important, for which different weight bearing recommendations are
suggested by surgeons like, non-weight bearing, toe-touch weight bearing,
partial weight bearing and full weight bearing.
It is believed that non-weight bearing joint is
unloaded, but any muscular co-contraction unpreventably causes increase in
joint contact forces. Due to controversies about advantages and disadvantages
of weight bearing recommendations, there is no consensus among orthopaedic
surgeons about weight bearing restrictions post-operatively.
Hence the study aims to see if muscle contraction
would vary in weight bearing and non-weight bearing standing, hence altering
joint loading.
For this purpose, peak muscle activity of 4 muscles
surrounding hip joint like rectus
femoris, medial hamstrings, gluteus maximus, gluteus medius will be assessed
using surface electromyography in partial weight bearing standing and
non-weight bearing standing position. |