| CTRI Number |
CTRI/2025/06/088814 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study Comparing the effects of Fascial massage than regular exercises for improving calf flexibility in people with flat feet |
|
Scientific Title of Study
|
Efficacy of fascial manipulation over traditional exercises in improving calf flexibility for asymptomatic flat foot recreational players |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keerti |
| Designation |
Post Graduate Student |
| Affiliation |
Abhinav Bindra Sports Medicine And Research Institute |
| Address |
House no 2, Lane 27, Bharat villa, Puri canal road, Rudrapur, Hansapal, Bhubaneswar
Abhinav Bindra Sports Medicine And Research Institute, Utkal Signature, Ground Floor, plot 269 and 273 NH5 Pahal, Bhubaneswar, Odisha
Khordha
ORISSA
752101
India |
| Phone |
9739773383 |
| Fax |
|
| Email |
keertivm2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyadarshini Mishra |
| Designation |
Associate Professor |
| Affiliation |
Abhinav Bindra Sports Medicine And Research Institute |
| Address |
Abhinav Bindra Sports Medicine And Research Institute, Utkal Signature, plot 269 and 273 NH5 Pahal, Bhubaneswar, Odisha 752101
Khordha
ORISSA
752101
India |
| Phone |
9438150665 |
| Fax |
|
| Email |
priyadarshinimishra@absmari.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyadarshini Mishra |
| Designation |
Associate Professor |
| Affiliation |
Abhinav Bindra Sports Medicine And Research Institute |
| Address |
Abhinav Bindra Sports Medicine And Research Institute, Utkal Signature, Plot 269 and 273 NH5 Pahal, Bhubaneswar, Odisha
Khordha
ORISSA
752101
India |
| Phone |
9438150665 |
| Fax |
|
| Email |
priyadarshinimishra@absmari.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Keerti |
| Address |
Bharat villa, Puri Canal Road, Rudrapur, Hansapal, Bhubaneswar 752101 |
| 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 Priyadarshini Mishra |
Abhinav Bindra Sports Medicine And Research Institute |
Abhinav Bindra Sports Medicine And Research Institute Utkal Signature, plot 269 and 273 NH5 Pahal, Bhubaneswar, 752101
Khordha
ORISSA |
9438150665
priyadarshinimishra@absmari.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Absmari Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Human healthy volunteers with flat feet |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fascial Manipulation and traditional exercises |
Fascial manipulation for calf,
the each myofascial points treated with 3 to 8mins.
Stretching exercises of calf. static stretching-30sec×3reps. Dynamic stretching-15times repeated movements.
Frequency: 3times per week |
| Comparator Agent |
Traditional exercises |
Stretching exercises of calf. static stretching-30sec×3reps. Dynamic stretching-15times repeated movements.
Frequency: 3times per week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Recreational players aged between 18 and 30 years. Asymptomatic flat foot using navicular drop test.
Dorsiflexion less than 20 degree with knee extended.
Participants of recreational sports activities at least 3 times per week
|
|
| ExclusionCriteria |
| Details |
Any lower limb musculoskeletal injury or surgery in the past 6 months.
Systemic Conditions: diabetes, rheumatoid Arthritis, or neurological disorders affecting gait or flexibility.
Orthotic use or undergoing physiotherapy treatment for Flat feet or calf tightness.
Medication Use(anti-inflammatory drugs or corticosteroids) that could influence muscle or fascial properties
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ankle dorsiflexion test in weight bearing lunge position using inclinometer |
Ankle dorsiflexion will be measured using inclinometer in degrees at basline after 2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Active ankle dorsiflexion range of motion test using goniometer |
Ankle dorsiflexion will be measured using goniometer in degrees at basline after 2 weeks and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/06/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Flat foot is a collapsed medial longitudinal arch and which can lead to compensatory changes in calf muscle and fascia, reducing flexibility and increasing injury risk. Fascial manipulation targets the deep fascia which may can improve calf flexibility along with the traditional exercises. For this, population will be asymptomatic flat-foot recreational athletes using convenience sampling and participant’s will be randomly allocated in two different groups one will be experimental group (Fascial Manipulation & traditional exercises) and another is control group(traditional exercises), then the intervention will be carried out for 4 weeks then at the last the collected data will be analyzed and interpreted from which final conclusion is drawn. |