| CTRI Number |
CTRI/2024/12/077611 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
"Testing Calf Muscle Strength with a Single-leg Heel Raise" |
|
Scientific Title of Study
|
Calf Muscle Endurance using Single Leg Heel Raise Test in Healthy 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 |
Bharathi K S |
| Designation |
Post Graduate Student |
| Affiliation |
Ramaiah University of Applied Sciences |
| Address |
Ramaiah College of Physiotherapy, Department of Physiotherapy,3rd floor seminar room 1, M S Ramaiah Nagara, MSRIT Post, Bangalore.
M S Ramaiah Nagar, MSRIT Post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
8073327096 |
| Fax |
|
| Email |
bharathis244@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Ruth Boyle |
| Designation |
Lecturer |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy, Department of Physiotherapy,3rd floor seminar room 1, Bangalore M S Ramaiah Nagara, MSRIT Post ,Bangalore-560054
M S Ramaiah Nagara, MSRIT Post ,Bangalore-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9945496325 |
| Fax |
|
| Email |
ruthboyle.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Ruth Boyle |
| Designation |
Lecturer |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy, Department of Physiotherapy,3rd floor seminar room 1, Bangalore M S Ramaiah Nagara, MSRIT Post ,Bangalore-560054
M S Ramaiah Nagara, MSRIT Post ,Bangalore-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9945496325 |
| Fax |
|
| Email |
ruthboyle.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| Ramaiah College of Physiotherapy, M S Ramaiah Nagara, MSRIT Post, Bangalore-560054 |
| Ramaiah Medical College and Hospital, M S Ramaiah nagara, MSRIT Post , Bangalore- 560054 |
| Ramaiah Memorial Hospital, M S Ramaiah Nagara, MSRIT post, Bangalore-560054 |
|
|
Primary Sponsor
|
| Name |
Bharathi K S |
| Address |
Ramaiah College of Physiotherapy, M S Ramaiah Nagara, MSRIT Post, Bangalore-560054 |
| 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 |
| Bharathi K S |
Ramaiah Medical college and Hospitals |
Department of Physiotherapy
Physiotherapy OPD,
M S Ramaiah Nagara, MSRIT Post, Bangalore-560054
Bangalore
KARNATAKA |
08073327096
bharathis244@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 20 - 60 years old Healthy individuals.
2. Both Male and Female will be included
|
|
| ExclusionCriteria |
| Details |
1. Any fractures in the lower limb from the past 6 months to 1 year.
2. Any Surgical procedure in the lower limb (THR, TKR, etc).
3. Any inflammatory conditions like osteoarthritis of the knee.
4. Congenital deformities of the foot.
5. Any Neurological conditions [congenital or acquired].
6. Individuals within the normal BMI of 18.5 to 25 kg/m2.
7. Individuals with any metabolic conditions include diabetes mellitus and hypertension.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| single leg heel raise test |
At baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="536"
Sample Size from India="536"
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)
|
15/12/2024 |
| 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="1"
Months="0"
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
|
The single-leg heel raise test is a reliable and practical method for assessing calf muscle endurance in healthy adults. It evaluates the ability of an individual to perform repeated heel raises while balancing on one leg reflecting functional muscle performance, particularly the gastrocnemius and soleus, to sustain repeated contractions against body weight. Normative data suggest that performance varies with age, gender, and physical activity levels, with younger and more active individuals typically achieving higher repetitions. This test is widely used in clinical and athletic settings to evaluate recovery, identify muscle imbalances, and provide rehabilitation baseline information. It provides essential insights into calf muscle function for injury prevention and performance improvement. |