| CTRI Number |
CTRI/2025/01/079058 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment Of Calf Muscle Flexibilty With Standing Balance And Moving Balance In Recreational Marathon Runners With Heel Pain. |
|
Scientific Title of Study
|
Correlation Of Gastrocnemius Muscle Flexibilty With Static And Dyanamic Balance in Recreational Marathon Runners With Plantarfasciitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarangi Prakash Kotwal |
| Designation |
MPT |
| Affiliation |
MAEERS Physiotherapy College Talegaon Dabhade |
| Address |
MAEERS college of Physiotherapy, 2nd Floor Musculoskeletal Physiotherapy Department Cabin A 207 Talegaon Dabhade, Pune Maharashtra
Pune MAHARASHTRA 410507 India |
| Phone |
9623831945 |
| Fax |
|
| Email |
swarangi128@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neetu Mahapatra |
| Designation |
Professor |
| Affiliation |
MAEERs Physiotherapy College Talegaon Dabhade |
| Address |
MAEERS College of Physiotherapy near Talegaon Railway Station 2nd floor Cabin A221 Musculoskeletal Physiotherapy Department Talegaon Dabhade Pune
Maharashtra
Pune MAHARASHTRA 410507 India |
| Phone |
9823236752 |
| Fax |
|
| Email |
neetu@mitmimer.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Neetu Mahapatra |
| Designation |
Professor |
| Affiliation |
MAEERS Physiotherapy CollegeTalegaon Dabhade |
| Address |
MAEERs College of Physiotherapy near Talegaon railway station 2nd floor Cabin A221 Musculoskeletal physiotherapy department Talegaon Dabhade Pune Maharashtra
Pune MAHARASHTRA 410507 India |
| Phone |
9823236752 |
| Fax |
|
| Email |
neetu@mitmimer.com |
|
|
Source of Monetary or Material Support
|
| MAEERS college of Physiotherapy Talegaon Dabhade |
|
|
Primary Sponsor
|
| Name |
N/A |
| Address |
N/A |
| 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 Neetu Mahapatra |
MAEERS Physiotherapy College Talegaon Dabhade |
Maeers Physiotherapy college A 207 Musculoskekeltal Physiotherapy Department opd building 2nd floor Talegaon Dabhade station Pune 410507
Pune MAHARASHTRA |
9823236752
neetu@mitmimer.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERS physiotherapy college ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Recreational marathon runners who are diagnosed plantarfasciitis by orthopeadic
Recreational marathon runners with minimum one year of running experience 5/10/half marathon |
|
| ExclusionCriteria |
| Details |
Recent lower limb fracture/surgery/soft tissue injury in last six months
Predisposing factors to heel pain like life style related disorders like Diabetes Thyroid Obesity
Limb length discrepancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weightbearing Lunge Test |
Pre assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Static Balance by Stork Standing Balance Test |
Pre Assessment |
| Dynamic Balance With Y Balance Test |
Pre Assessment |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
01/02/2025 |
| 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="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
|
Plantar fasciitis is a
commonest running related overuse syndrome occurring in recreational
marathon runners with a prevalence of 14.8% in males and 13.9% in females. Gastrocnemius muscle tightness is generally associated with plantarfasciitis. with increase in training there may be aggrevation of gastronemius muscle tightness which may lead to heel pain. Since balance and
gastrocnemius flexibility is an important factor required for maintaining
agility while running it is important to assess the balance affection and
gastrocnemius flexibility that may occur in marathon runners with plantar
fasciitis Running requires maintaining agility and flexibility that both maybe affected due to plantar fasciitis that in turn may affect there running performance hence it creates a need to find out a correlation between gastrocnemius muscle flexibility with static and dynamic balance.Sudden running may lead to decrease in gastrocnemius muscle flexibility which can hamper the running quality and running pace in marathon runners.Since balance and gastrocnemius flexibility is an important factor required for maintaining agility while running it is important to assess the balance affection and gastrocnemius flexibility that may occur in marathon runners with plantar fasciitis. Runners diagnosed with plantarfasciitis and fitting the inclusion criteria will be taken in the study and will be assessed for gastrocnemius muscle flexibilty using weight bearing lunge test and static balance will be assessed by using the stork standing test and dynamic balance will be assessed by using Y balance test. Collected data will be correlated using Pearson’s correlation coefficient and correlation will be plotted on Scatter digrams
|