| CTRI Number |
CTRI/2025/11/097587 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out the effect of Intrinsic Foot muscle and Tibialis Posterior Muscle Training on Flat Foot Correction and Dynamic Balance in Bharatnatyam Dancers |
|
Scientific Title of Study
|
Effect of Intrinsic Foot muscle and Tibialis Posterior Muscle Training on Flat Foot Correction and Dynamic Balance in Bharatnatyam Dancers. A Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sambodhi Ghanghav |
| Designation |
Student |
| Affiliation |
Pravara Institute of medical sciences |
| Address |
Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra Ahmadnagar Maharashtra 413736 India
Ahmadnagar
MAHARASHTRA
413736
India Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra Ahmadnagar Maharashtra 413736 India
Ahmadnagar
MAHARASHTRA
413736
India Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
9326376929 |
| Fax |
|
| Email |
ghanghavsambodhi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepali Hande |
| Designation |
Professor and Head of Department |
| Affiliation |
Pravara Institute of medical sciences |
| Address |
Community physiotherapy department Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra Ahmadnagar Maharashtra 413736 India
Ahmadnagar
MAHARASHTRA
413736
India Community physiotherapy department Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra Ahmadnagar Maharashtra 413736 India
Ahmadnagar
MAHARASHTRA
413736
India Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8275034001 |
| Fax |
|
| Email |
deepali.hande@pmtpims.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepali Hande |
| Designation |
Professor and Head of Department |
| Affiliation |
Pravara Institute of medical sciences |
| Address |
Community physiotherapy department Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra Ahmadnagar Maharashtra 413736 India
Ahmadnagar
MAHARASHTRA
413736
India Community physiotherapy department Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra Ahmadnagar Maharashtra 413736 India
Ahmadnagar
MAHARASHTRA
413736
India Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8275034001 |
| Fax |
|
| Email |
deepali.hande@pmtpims.org |
|
|
Source of Monetary or Material Support
|
| Dr APJ Abdul Kalam College Of Physiotherapy and local dance classes in loni, loni 413736,Ahmednagar, Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 |
| Sambodhi Ghanghav |
Dr APJ Abdul Kalam College Of Physiotherapy |
Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra Ahmadnagar Maharashtra 413736 India
Ahmadnagar
MAHARASHTRA
413736
India Ahmadnagar MAHARASHTRA |
09326376929
ghanghavsambodhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Flat Foot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
1.Warm up exercises
a)Toe raises
b)Ankle circles
c)Arch lifts
2.Stretching (low intensity) a)Calf stretch
b)Achilles tendon stretch
3.Low impact activities Walking and cycling
4.Foot Care
Advice on footwear
|
| Intervention |
Strenghtening and flexibility exercises with conventional physiotherapy |
1.Warm up exercises
a)Toe raises
b)Ankle circles
c)Arch lifts
1.Strengthening Exercises a) Towel scrunches
b) Marbel Pickup
c) Heel Raises
d) Ankle and Calf strengthening
e)Foot Roll
f) Toe curls
2. Stretching and flexibility Exercises
a) Calf Stretches
b)Plantar Fascia Stretch
c) Achilles Tendon Stretch
Duration 6 Week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Bharatnatyam dancers aged 18–35 years.
2. Dancers with at least 3 years of continuous training in Bharatanatyam.
3. Participants diagnosed with flat foot through a clinical assessment i.e. (Navicular Drop Test).
4. No history of lower limb fractures, surgeries, or acute musculoskeletal injuries within the past six months.
5. Participants actively practicing Bharatanatyam for at least 4 hours per week.
6. Participants willing to participate.
|
|
| ExclusionCriteria |
| Details |
1. Participants with a history of fractures, ligament tears, tendon injuries, or surgical interventions affecting the foot, ankle, or lower limb.
2. Participants with musculoskeletal conditions affecting foot biomechanics and balance.
3. Participants with rigid flatfoot, clubfoot, hallux valgus, or other congenital anomalies that may alter study outcomes.
4. Participants diagnosed with vertigo, or any other conditions affecting equilibrium and postural control.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Foot Posture index.
Timed Up and Go (TUG) Test
|
baseline 0week and 6 th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Y Balance Test |
week 0 to week 6 |
|
|
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)
|
20/11/2025 |
| 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
|
| 1. The Participants will be selected based on the eligibility criteria. 2. Informed consent will be obtained from the participants and demographic data will be recorded. 3. The participants will be explained about the procedure and will be ensured that no harm will be caused to them. 4. Participants will be randomly allocated to 2 groups that is experimental group (n=30) and control group (n=30). 5. Both group participants will be given intervention of strengthening exercises, stretching exercises and manual therapy for 6 weeks. 6. The results of the two groups will be analyzed and effectiveness of the therapy in the groups will be noted.
1.Warm up exercises: | a)Toe raises b)Ankle circles | c)Arch lifts2.Stretching: b)Achilles tendon stretch 3.Low impact activities: Walking and cycling 4.Foot Care: Advice on footwear
| Group B: Experimental group | 1.Warm up exercises: | a)Toe raises b)Ankle circles | c)Arch lifts2.Strengthening Exercises: a) Towel scrunches b) Marbel Pickup c) Heel Raises d) Ankle and Calf strengthening e)Foot Roll f) Toe curls 3.Stretching and flexibility Exercises: a) Calf Stretches b)Plantar Fascia Stretch c) Achilles Tendon Stretch
| Frequency: 5 days per week (5 reps x 2 set of each exercise) Intensity: 10 sec hold Time: 30 min Type: Strengthening, stretching and manual therapy | | |