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CTRI Number  CTRI/2024/06/068523 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Enhancing lower limb alignment in flexible flatfoot: the impact of comprehensive exercises 
Scientific Title of Study   Effect of comprehensive exercises on lower limb alignment factors in young adults with flexible flatfoot: an experimental study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Disha D Shetty 
Designation  Post graduate student 
Affiliation  NITTE Institute of Physiotherapy, NITTE(Deemed to be University) 
Address  Department of Physiotherapy, Room number 20,second base division, NITTE Institute of Physiotherapy, NITTE(Deemed to be University),Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9380198175  
Fax    
Email  shettydisha2018@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saumya Srivastava 
Designation  Associate Professor 
Affiliation  NITTE Institute of Physiotherapy, NITTE (Deemed to be University) 
Address  Department of Physiotherapy, Room number 20,second base division, NITTE Institute of Physiotherapy, NITTE(Deemed to be University),Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740244077  
Fax    
Email  saumyasri2000@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Disha D Shetty 
Designation  Post graduate student 
Affiliation  NITTE Institute of Physiotherapy, NITTE (Deemed to be University) 
Address  Department of Physiotherapy, Room number 20,second base division, NITTE Institute of Physiotherapy, NITTE(Deemed to be University),Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9380198175  
Fax    
Email  shettydisha2018@gmail.com  
 
Source of Monetary or Material Support  
NITTE Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka-575018, India will provide basic infrastructure facilities, no other monetary support is required 
 
Primary Sponsor  
Name  NITTE Institute of Physiotherapy NITTE Deemed to be University 
Address  Department of Physiotherapy, room number 20,second base division,NITTE institute of physiotherapy ,NITTE (deemed to be university),Deralakatte,Mangaluru,Karnataka-575018,India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Disha D Shetty  Justice K S Hegde Charitable Hospital   Department of physiotherapy, Room number 20, second base division, NITTE Institute of physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA 
9380198175

shettydisha2018@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of NITTE Institute of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comprehensive exercise program  This is a single-group pre-post-intervention study. After posture analysis of all participants via GaitOn software, a posture analysis system, a comprehensive exercise program will be administered, which includes short foot exercises, foot supination exercise, hip abductor exercise, and wall squats. Exercises will be progressed after 2 weeks with alteration in the position (ie., sitting, standing, and single-leg stance) and/or an increase in hold time and number of repetitions. The intervention will be performed at three sessions per week for 8 weeks. All participants will be required to attend the gait lab /clinic 3 times—at baseline, 4 weeks, and 8 weeks to obtain outcome measures and review the exercises. The obtained values for the lower limb alignment factors will be entered in the data collection sheet. A comparison of the outcome measures within the group over time (baseline,4 weeks, and 8 weeks) will be performed.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. BMI within the normal range – 18.5-24.9 kg/m2
2. Navicular drop height of more than 10mm
3. Medial longitudinal arch angle less than 130 degree
 
 
ExclusionCriteria 
Details  1. Pain anywhere in the lower extremity
2. History of any lower extremity surgery
3. History of trauma or accidents to the lower extremities
4. Neurological conditions affecting the lower extremities
5. Congenital deformity of the lower limb
6. Patients with hyperlaxity graded with Beighton score (score of 4-9)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
GaitON software - posture analysis system  The posture analysis will be performed at baseline, 4 weeks, and 8 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
OHM 3000- plantar pressure system  The analysis will be performed at baseline, 4 weeks, and 8 weeks 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
Final Enrollment numbers achieved (Total)= "27"
Final Enrollment numbers achieved (India)="27" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   17/06/2024 
Date of Study Completion (India) 08/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 08/02/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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, also known as pes planus, is characterized by a reduced curvature of the medial longitudinal arch, causing the entire sole to make close to complete contact with the ground.There exists a variation in the prevalence of flat foot. The likelihood of having flat feet varies with age, sex, body mass index, ethnicity, type of population being investigated, and presence of other associated musculoskeletal pathologies. The prevalence of flat foot in children is high due to ligament laxity, which reduces with age. Among children aged two to six, the prevalence of flexible flat foot ranges from 21 to 57%. In elementary school, the percentage drops to 13–28%. 42% of people between the ages of 11 and 16 have the prevalence, of which 23% have bilateral flat feet and 19% have unilateral flat foot. At least 20% to 30% of young adults have reported having flat feet; the frequency is slightly higher in girls (14.4%) than in boys (12.8%).Although individuals with asymptomatic flexible flatfoot do not report foot pain, discomfort, or fatigue, this condition can impair dynamic foot functions and is also associated with a higher risk of lower limb overuse injuries. A model of biomechanical linkages of the lower extremity in closed-kinetic chain activities hypothesizes that the increased pronation of the foot may have an impact on the movement pattern of proximal joints. Weakness and dysfunction of the hip external rotator may result in hip adduction, medial rotation, and dynamic knee valgus, influencing foot pronation.Weakness in the gluteal muscles can contribute to internal hip joint rotation, leading to foot pronation.Individuals with flat feet exert increased plantar pressure on the midfoot region compared to that of normal foot individualsRestoring appropriate muscle recruitment patterns and improving strength and performance can be accomplished by reactivating the gluteal muscles.Studies have shown that gluteal strengthening exercises along with foot exercises are effective in decreasing navicular drop and medial plantar pressure and increasing arch height index and static balance. However, there is a lack of good certainty evidence about the effectiveness of comprehensive exercises over entire lower limb alignment factors.GaitON® software is one such 2-D posture analysis system that analyses the standing posture of the patient and identifies key postural deviation from multiple views & exports all data to a report.It is an appropriate evaluation tool for diagnosing initial postural disorders, postural comparisons before and after rehabilitation programs with excellent Inter-rater and Intra-rater reliability: ICC > 0.99 for hip and knee angles.Thus, this study intends to evaluate how a comprehensive exercise program will help in improving the lower extremity alignment of individuals with flexible flatfoot.

This research may also help to determine the extent of alterations in the lower limb alignment factors following the initiation of comprehensive exercises for individuals with flexible flatfoot. Our findings may provide a resolution to the challenges associated with determining the role of static lower extremity alignment in increasing the risk of lower extremity injury. Incorporating measures of static lower extremity alignment in prospective study designs will help us identify individuals at greatest risk of injury and contribute to the development of more effective intervention programs to mitigate such risks.

Thus, this study intends to evaluate how a comprehensive exercise program will help in improving the lower extremity alignment of individuals with flexible flatfoot.

This research may also help to determine the extent of alterations in the lower limb alignment factors following the initiation of comprehensive exercises for individuals with flexible flatfoot. Our findings may provide a resolution to the challenges associated with determining the role of static lower extremity alignment in increasing the risk of lower extremity injury. Incorporating measures of static lower extremity alignment in prospective study designs will help us identify individuals at greatest risk of injury and contribute to the development of more effective intervention programs to mitigate such risks.

 
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