| 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
|
|
|
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
|
|
|
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. |