| CTRI Number |
CTRI/2025/07/091476 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on The Effect of Calf Muscle Tightness on Foot Pressure in People with Heel Pain |
|
Scientific Title of Study
|
impact of gastrocnemius tightness on plantar pressure distribution among individuals with heel pain |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lokesh R |
| Designation |
Bachelor of Physiotherapy |
| Affiliation |
SRM college of physiotherapy |
| Address |
Room no PT 12,fifth floor,
SRM college of physiotherapy,SRM Institute of Science and Technology,
kattankulathur,
chengalpattu district,
Tamil Nadu.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500806335 |
| Fax |
|
| Email |
lokeshravi243@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sowmiya M |
| Designation |
MPT in biomechanics |
| Affiliation |
SRM college of physiotherapy |
| Address |
SRM college of physiotherapy,
kattankulathur campus,
chengalpattu district,
Tamil Nadu-603203
Chennai
TAMIL NADU
603203
India |
| Phone |
6369290837 |
| Fax |
|
| Email |
sowmiyam1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sowmiya M |
| Designation |
MPT in biomechanics |
| Affiliation |
SRM college of physiotherapy |
| Address |
Room : 14 , Expert Paradise ,SRM college of physiotherapy, SRM Institute of Science and Technology,
kattankulathur,
chengalpattu district,
Tamil Nadu.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6369290837 |
| Fax |
|
| Email |
sowmiyam1@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM college of physiotherapy,
SRM institute of science and technology,
kattankulathur campus,
chengalpattu district,
Tamil Nadu-603203 |
|
|
Primary Sponsor
|
| Name |
Lokesh R |
| Address |
SRM college of physiotherapy,
kattankulathur campus,
chengalpattu district,
Tamil Nadu-603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sowmiya |
SRM Hospital and Research Centre |
Room no PT 12,fifth floor,
SRM college of physiotherapy,SRM Institute of Science and Technology
kattankulathur campus,
chengalpattu district,
Tamil Nadu-603203
Kancheepuram
TAMIL NADU |
6369290837
sowmiyam1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| srm institution ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
individual with heel pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil
|
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
History of heel pain (specifically plantar fasciitis or any other condition causing heel pain).
Acute pain
VAS score is greater than 6
BMI ( 24.9-29.9 ) within normal limits
Ability to participate in the study by attending assessment sessions. |
|
| ExclusionCriteria |
| Details |
History of recent foot or ankle surgeries
Foot deformities
Recent fracture around lower limb
Neurological or musculoskeletal disorders that could influence gait or foot function (e.g peripheral neuropathy, stroke)
Individuals with significant cardiovascular or systemic diseases.
Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| foot pressure distribution changes in relation to calf muscle tightness |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/08/2025 |
| 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
|
Gastrocnemius tightness reduces ankle dorsiflexion which alters gait mechanics and shifts plantar pressure away from the heel toward the forefoot This compensation increases pressure under the forefoot and can lead to early heel lift reducing heel contact time As a result the heel absorbs more force during initial contact potentially worsening heel pain especially in conditions like plantar fasciitis The tightness also increases strain on the plantar fascia contributing to chronic pain Addressing gastrocnemius tightness through stretching or therapy can help normalize pressure distribution and alleviate symptoms |