| CTRI Number |
CTRI/2024/03/063776 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assess Hip Abductors Muscle Strength on Balance in old people: A Cross-Sectional Investigation |
|
Scientific Title of Study
|
Influence of Hip Abductors Muscle Strength on Balance in Community Dwelling Older Adults. A Cross-sectional 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 |
Mansi Shrikant Sarolkar |
| Designation |
1st year pg student |
| Affiliation |
College of physiotherapy, Sumandeep Vidyapeeth deemed to be university |
| Address |
College of physiotherapy , Sumandeep Vidyapeeth deemed to be University, Piparia, Waghodiya , Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
9404514260 |
| Fax |
|
| Email |
mansi.sarolkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mansi Shrikant Sarolkar |
| Designation |
1 year pg student |
| Affiliation |
College of physiotherapy, Sumandeep Vidyapeeth deemed to be university |
| Address |
College of physiotherapy, Sumandeep Vidyapeeth deemed to be university, Piparia, Waghodiya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9404514260 |
| Fax |
|
| Email |
mansi.sarolkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rushikesh Joshi |
| Designation |
Associate professor |
| Affiliation |
College of physiotherapy, Sumandeep Vidyapeeth deemed to be university |
| Address |
College of physiotherapy, Sumandeep Vidyapeeth deemed to be university, Piparia, Waghodiya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8141633941 |
| Fax |
|
| Email |
drrushikesh.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| This is a self funded study , the infrastructure is provided by college of physiotherapy , Sumandeep Vidyapeeth deemed to be university. |
|
|
Primary Sponsor
|
| Name |
Mansi Shrikant Sarolkar |
| Address |
COLLEGE OF PHYSIOTHERAPY, SUMANDEEP VIDYAPEETH DEEMED TO BE UNIVERSITY, PIPARIA, WAGHODIA, VADODARA. |
| Type of Sponsor |
Other [Self-funded ] |
|
|
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 |
| Mansi Shrikant Sarolkar |
Dhiraj general hospital |
DGH (Dhiraj general hospital), Piparia, Waghodiya, Vadodara , Gujarat
Vadodara
GUJARAT |
9404514260
mansi.sarolkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep vidyapeeth institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Community dwelling older adults.
Healthy individuals both male and female.
Subjects with upper age limit 80 years and lower age limit 60 years. |
|
| ExclusionCriteria |
| Details |
Neurological conditions that compromise the muscle strength.
Cognitive impaired subjects.
Recent surgeries involved in lower limb fractures, recent surgeries and any other cardiovascular surgeries. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sphygmomanometer device.
Time-up and Go test. |
10 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2024 |
| Date of Study Completion (India) |
05/04/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is a cross-sectional trial corelating the influence of hip abductors strength and balance in community dwelling older adults in 100 subjects which are healthy individuals , that will be conducted in nearby villages surrounding Sumandeep Vidyapeeth deemed to be University. The primary outcome measures will be sphygmomanometer readings which will be measured by isometric contraction of hip abductors muscle by pre inflated cuff of 20 mm hg for measuring hip abductor strength and Time-up and Go test for balance . The readings will be documented and analyzed. Hence the purpose of the study is to find relationship between hip abductor muscle strength and balance in community dwelling older adults. |