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CTRI Number  CTRI/2025/03/083404 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How the Thickness of Gastrocnemius muscle affects physical ability in people with sarcopenia and plantar fasciitis - An Ultrasonographic study  
Scientific Title of Study   Gastrocnemius Muscle Thickness and its Influence on Physical Performance among Subjects with Sarcopenia and Plantar Fasciitis - An Ultrasonographic Analysis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ponni Priyanka A S 
Designation  Student 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy,outpatient department,ground floor, No.1, Sri Ramachandra nagar, Porur, Chennai-600116.

Chennai
TAMIL NADU
600116
India 
Phone  7871285192  
Fax    
Email  ponnipriyanka21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Geetha Hari Priya G A 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy,outpatient department,ground floor, No.1, Sri Ramachandra nagar, Porur, Chennai-600116.

Kancheepuram
TAMIL NADU
600116
India 
Phone  7358580685  
Fax    
Email  geethaharipriya@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Geetha Hari Priya G A 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy,outpatient department,ground floor, No.1, Sri Ramachandra nagar, Porur, Chennai-600116.

Chennai
TAMIL NADU
600116
India 
Phone  7358580685  
Fax    
Email  geethaharipriya@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy,outpatient department,ground floor, No.1, Sri Ramachandra nagar, Porur, Chennai-600116. 
 
Primary Sponsor  
Name  Ponni Priyanka A S 
Address  Sri Ramachandra Institute of Higher Education and Research, Trunk road, sri ramachandra nagar,Porur, Chennai - 600116 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ponni Priyanka A S  Sri Ramachandra Institute of Higher Education and Research  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy,outpatient department,ground floor, No.1, Sri Ramachandra nagar, Porur, Chennai-600116.
Chennai
TAMIL NADU 
7871285192

ponnipriyanka21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Students Projects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  NIL  NA 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Both genders were represented.
Age group of 40 and above were included in the study.
Patients diagnosed with sarcopenia.
Pain when the proximal plantar fascia or medial calcaneal tubercle was palpated.
A minimum of three months prior to enrollment, a history of inferior heel pain.
 
 
ExclusionCriteria 
Details  History of systemic diseases.
Injection of steroids for plantar fasciitis within the last six months.
Pregnant women.
People below the age of 30 years.
The participant’s medical history form, including any concerns about their health (cancer, tumor, fracture).

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. SARC-CalF Questionnaire
2. Gastrocnemius Muscle Thickness using Ultrasonography

 
Baseline only 
 
Secondary Outcome  
Outcome  TimePoints 
4 meter Walk test  Baseline only 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   31/03/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Plantar fasciitis is the most common cause of heel pain affecting 10 -15 percentage of the general population.In Indian population the Prevalence of patients with heel pain and calcaneal spur is to be 59 percentage. The aim of the study is to analyze gastrocnemius muscle thickness using ultrasonography and its influence on physical performance among subjects with sarcopenia and plantar fasciitis. Windlass test is done to test plantar fasciitis in patients coming to physiotherapy OPD.SARC-CalF questionnaire is filled by the therapist in order to find if the patient is sarcopenic or non-sarcopenic. Patients having greater than or equal to 4 score in this questionnaire with Calf Circumference less than 34 cm for men or less than 33 cm for women indicates low muscle mass. Then patients are taken for an ultrasonography imaging, through which the muscle thickness of the medial gastrocnemius is to be assessed. Those with medial gastrocnemius muscle thickness reduced more than 1.5cm are taken in the sarcopenic group, and patients having muscle thickness 1.5cm or more are taken in the non-sarcopenic group. After assessing the medial gastrocnemius thickness, the patient’s physical performance is assessed in both the groups. For assessing the physical performance, the patient is asked to walk a distance of 4 meters in a straight line. 0.8m per sec is the optimal time for the patient to walk. Patients should complete 4 meters in 3.2seconds.
 
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