| CTRI Number |
CTRI/2026/03/105678 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Ankle Movement and Pain in New Runners with Shin splints |
|
Scientific Title of Study
|
Relationship between ankle dorsiflexion range of motion and pain severity in novice runners with shin splints |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushbu kumari |
| Designation |
BPT student |
| Affiliation |
Maharishi Markandeshwar Institute of physiotherapy mullana , ambala, Haryana |
| Address |
Department of Physiotherapy, Mharishi Markandeshwar (Deemed to be) University , Mullana , Ambala , Haryana , India
Ambala
HARYANA
133207
India |
| Phone |
9801739256 |
| Fax |
|
| Email |
kumarikhushbu512003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivangi Palsra |
| Designation |
Assistant Professor MMIPR ,MMDU |
| Affiliation |
Maharishi Markandeshwar Institute of physiotherapy mullana , ambala, Haryana |
| Address |
Department of Physiotherapy, Mharishi Markandeshwar (Deemed to be) University , Mullana , Ambala , Haryana , India
Ambala
HARYANA
133207
India |
| Phone |
8219875322 |
| Fax |
|
| Email |
Shivangi@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivangi Palsra |
| Designation |
Assistant Professor MMIPR ,MMDU |
| Affiliation |
Maharishi Markandeshwar Institute of physiotherapy mullana , ambala, Haryana |
| Address |
Department of Physiotherapy, Mharishi Markandeshwar (Deemed to be) University , Mullana , Ambala , Haryana , India
HARYANA
133207
India |
| Phone |
8219875322 |
| Fax |
|
| Email |
Shivangi@mmumullana.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Khushbu kumari |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy And Rehabilitation, Maharishi Markandeshwar (Deemed to be ) University Mullana,Ambala,Haryana 133207 |
| Type of Sponsor |
Other [] |
|
|
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 shivangi Palsra |
Khushbu kumari |
Hostel 7 near Maharishi Markandeshwar Institute of Physiotherapy And Rehabilitation ,MMDU, Mullana, Ambala
Ambala
HARYANA |
8219875322
Shivangi@mmumullama.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE Maharishi Makandeshwar Institute OF Medical Science and Research, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
novice runner |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female
Age group between 18to 35 years
Running experience less than 6
months
Participants classified as novice
runners
Participants with medial tibial
pain due to shin splints. |
|
| ExclusionCriteria |
| Details |
Participants with previous fracture
Neurological disorders
Lower limb surgery
Tibial stress fracture
Compartment syndrome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
MTSS Score (Questionnaire)
NPRS (numerical pain rating scale)
ROM ANKLE |
One Time
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
22/03/2026 |
| 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 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
|
This study examines the relationship between ankle dorsiflexion range of motion (ROM) and pain severity in novice runners with medial tibial stress syndrome (shin splints). Limited ankle dorsiflexion may alter lower limb biomechanics and increase stress on the tibia. Ankle ROM will be assessed using standard measurement techniques, and pain severity will be measured using a validated pain scale. The study aims to determine whether reduced dorsiflexion is associated with higher pain intensity. Findings may help guide physiotherapy interventions for prevention and management. |