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CTRI Number  CTRI/2026/03/106186 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of modified foot orthoses and foot-ankle exercises in young adults with flexible flat foot 
Scientific Title of Study   Clinical outcome of modified foot orthoses and three dimensional foot ankle exercise in young adults with flexible flat foot 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SANDEEP KUMAR 
Designation  PhD Scholar  
Affiliation  School of Paramedical and Allied Health Sciences, Shri Guru Ram Rai University, 
Address  Shri Mahant Indresh Hospital Department of Physiotherapy, North Block , Basement

Dehradun
UTTARANCHAL
248001
India 
Phone  09412468744  
Fax    
Email  drskumarmalik@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof (Dr.) Niraj Kumar  
Designation  Professor  
Affiliation  School of Paramedical and Allied Health Sciences, Shri Guru Ram Rai University, 
Address  Shri Mahant Indresh Hospital Department of Physiotherapy, North Block ,Room no. 5 Basement

Dehradun
UTTARANCHAL
248001
India 
Phone  9997516613  
Fax    
Email  nirajkumar@sgrrmc.com  
 
Details of Contact Person
Public Query  
Name  SANDEEP KUMAR 
Designation  PhD Scholar  
Affiliation  School of Paramedical and Allied Health Sciences, Shri Guru Ram Rai University, 
Address  Shri Mahant Indresh Hospital Department of Physiotherapy, North Block , Basement

Dehradun
UTTARANCHAL
248001
India 
Phone  09412468744  
Fax    
Email  drskumarmalik@gmail.com  
 
Source of Monetary or Material Support  
Self  
 
Primary Sponsor  
Name  Sandeep Kumar  
Address  Department of Physiotherapy, Shri Mahant Indiresh Hospital, Pathribagh Dehradun, 248001  
Type of Sponsor  Other [Self ] 
 
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 
Dr Sandeep Kumar PT  Shri Mahant Indiresh Hospital  Room no. 5, North Block Basement, Department of Physiotherapy, Shri Mahant Indiresh Hospital
Dehradun
UTTARANCHAL 		 09412468744

drskumarmalik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Exercises  Conventional foot exercises, are involved a series of warm up, strengthening, stretching and balancing. Total duration of intervention 30 minutes. 
Intervention  MODIFIED FOOT ORTHOSES AND CONVENTIONAL EXERCISES   The intervention for addressing flexible flat foot involves the usage of modified foot orthoses manufactured from polypropylene material. those Orthoses characteristic key modification of navicular support guide to manipulate immoderate pronation,. The goal is to beautify foot posture, alleviate ache, and improve useful consequences through targeted biomechanical correction. Members will follow a gradual carrying protocol, beginning with 1–2 hours every day for the first Three days, steadily growing to 5 – 6 hours according to day via the quit of the first week. They will keep to put on the orthoses for a total of eight weeks while standing and walking. All participants might be advised to put on the orthoses with closed, supportive footwear to ensure most advantageous therapeutic benefit. Conventional feet exercises, are involved a series of warm up, strengthening, stretching and balancing. Total duration of intervention 30 minutes. 
Comparator Agent  Three dimensional foot ankle exercise and Conventional Exercises   Foot-ankle exercises will applied in diagonal 1 and 2 directions in the PNF pattern, based on the methodology described by (Dilek Hande esen et all 2025). An elastic band will used to create resistance to the movement. The exercise intensity will determined as a level between 3 -7 (moderate – very strong) according to the perceive advance level on the Borg CR-10 scale. Exercises will started with a red (light) band. Progress will achieved by switching to a higher-level band color green (medium), blue (moderate), and black (difficult) respectively every two weeks. Exercise will performed in three sets of 10 repetitions, with a 1-minute rest period between sets. When the participant reached the end point of the movement, maintain this position for 05 seconds. Conventional feet exercises, are involved a series of warm up, strengthening, stretching and balancing. Total duration of intervention 30 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Navicular drop test greater than 10 mm
2. Foot Posture Index greater than +6
3. Having flexible flat foot according to the Jack test.
4. Not describing lower limb pain or fatigue in the past 06 months.
5. Participants willing to participate
 
 
ExclusionCriteria 
Details  1. A lack of anatomical integrity of the foot.
2. Rigid flat foot, hallux limits and plantar fasciitis.
3. Previous history of foot or ankle fracture or surgery.
4. Orthopaedic or rheumatological disease of the spine or lower limbs.
5. Neurological disorders affecting lower limb function.
6. Balance Problems.
7. Receiving conservative treatment for flat foot within the last year.
8. Body mass index greater than 30kg/m²
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Foot Posture Index (FPI-6)
Navicular Drop Test
Rear foot eversion on calcaneus stance position
One-leg standing Test
Y balance test
 		 1st day, 28th day, 56th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil   Nil  
 
Target Sample Size   Total Sample Size="117"
Sample Size from India="117" 
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)   15/04/2026 
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="2"
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 PhD study investigates the clinical effectiveness of different conservative treatment approaches for flexible flat foot (FFF) in young adults. Flexible flat foot is characterized by the collapse of the medial longitudinal arch during weight-bearing, which can lead to altered gait, poor balance, and increased risk of lower-limb injuries. The study aims to compare three intervention strategies: (1) modified navicular-support foot orthoses combined with conventional foot exercises, (2) three-dimensional foot–ankle exercises combined with conventional exercises, and (3) conventional foot exercises alone. A randomized controlled trial will include 117 participants aged 18–25 years, divided equally into three groups and treated for 8 weeks. Outcomes such as Foot Posture Index (FPI-6), navicular height, rearfoot eversion angle, and static and dynamic balance will be assessed at baseline, 4 weeks, and 8 weeks. The purpose is to determine which intervention most effectively improves foot posture, arch stability, and balance, thereby providing evidence for an optimal physiotherapy-based rehabilitation protocol for managing flexible flat foot in young adults.
 
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