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CTRI Number  CTRI/2025/09/094710 [Registered on: 12/09/2025] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Checking foot health and strength in peoples with type 2 diabetes 
Scientific Title of Study   Evaluation of the foot core system in type 2 diabetic population 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahul kumar gond 
Designation  MPT musculoskeletal student  
Affiliation  AmarJyoti institute of physiotherapy 
Address  Physiotherapy Department,Lecture room 1, Thrid Floor.Amar Jyoti institute of physiotherapy Karkardooma Vikas Marg Delhi 110092

East
DELHI
110092
India 
Phone  8223914958  
Fax    
Email  karpe040@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prerna saxena  
Designation  Assistant professor  
Affiliation  AmarJyoti institute of physiotherapy 
Address  BPT Physiotherapy Department, Faculty Room, Second floor.Amar Jyoti institute of physiotherapy karkardooma Vikas Marg Delhi 110092

East
DELHI
110092
India 
Phone  9999456988  
Fax    
Email  prernasaxena.88@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr madhvi  
Designation  Assistant professor  
Affiliation  AmarJyoti institute of physiotherapy 
Address  BPT Physiotherapy Department, Faculty Room, Second floor.Amar Jyoti institute of physiotherapy karkardooma Vikas Marg Delhi 110092

East
DELHI
110092
India 
Phone  9650058232  
Fax    
Email  madhvipt94@gmail.com  
 
Source of Monetary or Material Support  
Amarjyoti Institute of Physiotherapy College Karkardooma Vikas Marg Delhi 110092, India 
 
Primary Sponsor  
Name  Rahul kumar gond  
Address  Amarjyoti Institute of Physiotherapy College Karkardooma Vikas Marg Delhi 110092, 
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 
DrRahul kumar gond   Amarjyoti Institute of Physiotherapy   Physiotherapy Department,lecture room 1, thrid floor,Amarjyoti institute of physiotherapy karkartdooma Vikas Marg delhi-110092
East
DELHI 
8223914958

karpe040@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amarjyoti institute Review Bord- Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals Diagnosed with Type 2 diabetes mellitus (T2DM) for at least 5 years according
to WHO criteria (fasting blood glucose greater than 126 mg/dL or HbA1c greater than 6.5 percent). 
 
ExclusionCriteria 
Details  1. History of foot ulcers, amputations, or severe foot deformities.
2. Ruled out using the Michigan neuropathy screening instrument (MNSI)
3. Any neurological or musculoskeletal disorders affecting balance and gait (e.g., stroke,
Parkinson’s disease, severe osteoarthritis).
4. Use of orthotic insoles or assistive devices that may alter foot function.
5. Uncontrolled diabetes (HbA1c greater than 9 percent) or any other systemic illness that affects mobility.
6. Recent lower limb injury or surgery (within the last 6 months). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Navicular Drop Test
2.Card Test
3.Towel Toe Curling Test
4.One Leg Stand Test (OLST)
5.Ohm 3000 Plantar Pressure System.
6.Hand- held dynamometer.  
Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   11/10/2025 
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="6"
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  

INTRODUCTION 

 

Diabetes mellitus type 2 (T2DM) is a growing global health concern, with India being one of the most affected countries. According to the World Health Organization (WHO), as of 2023, over 101 million people in India are living with diabetes, and an additional 136 million have prediabetes (WHO, 2023). The increasing burden of diabetes is largely attributed to lifestyle changes, urbanization, genetic predisposition, and an aging population (International Diabetes Federation [IDF], 2023). One of the major concerns associated with T2DM is its impact on musculoskeletal and neuromuscular health, which significantly affects mobility, postural stability, and foot function. The human foot is a complex and highly adaptable structure that plays a key role in balance, stability, and movement. The foot has to absorb shock when it hits the ground while also staying firm enough to push the body forward. One important concept in foot function is the foot core system, which comprises intrinsic and extrinsic foot muscles, ligaments, and the plantar fascia, plays a crucial role in maintaining foot stability, postural balance, and shock absorption during weight-bearing activities. Dysfunction within this system can lead to foot deformities, altered gait mechanics, and increased risk of falls. In individuals with T2DM, neuropathy, vascular insufficiency, and biomechanical alterations can contribute to progressive weakening of the foot core system, increasing susceptibility to diabetic foot ulcers (DFUs), Charcot foot, and other musculoskeletal complications. Given that diabetic foot complications account for nearly 20% of all diabetes-related hospital admissions in India (WHO, 2023), it is crucial to evaluate foot function and stability at an early stage. Despite the high prevalence of diabetes-related foot complications, the assessment of the foot core system remains significantly underexplored in clinical settings. In current clinical practice managing advanced diabetic foot complications—such as ulcers, infections, and structural deformities are focused rather than focusing on early screening and preventive interventions. Emerging evidence suggests that diabetes-related changes in foot muscle function occur long before the onset of visible structural deformities. Neuromuscular impairments, muscle atrophy, and proprioceptive deficits are commonly reported in individuals with T2DM, even in the absence of overt neuropathy. The purpose of this study is to assess and compare the foot core system in individuals with T2DM and non-diabetic individuals to determine the extent of diabetes-related alterations in foot stability and function. By identifying these impairments early, clinicians can implement preventive and rehabilitative strategies to improve foot biomechanics, reduce the risk of diabetic foot complications, and enhance the overall quality of life for individuals with diabetes. Given India’s rapidly increasing diabetes burden, early evaluation and intervention can play a significant role in reducing long-term disability and healthcare costs associated with diabetic foot disorders. So, the study aim to evaluate foot core system in type 2 diabetic patient.

 

NEED OF THE STUDY 

 

 Diabetes is becoming a serious health concern in India, affecting millions of people. Many know about its impact on blood sugar levels, but few realize how much it can affect the feet. People with Type 2 diabetes (T2DM) often experience weak foot muscles, poor balance, and difficulty walking, even before they notice any major problems. Over time, these small changes can lead to serious complications like foot deformities, ulcers, and a higher risk of falls. The feet play a vital role in movement and daily activities, and a strong foot core system—made up of muscles, ligaments, and the plantar fascia—helps to stay stable, balanced, and active. But in diabetes, this system can weaken, often without clear warning signs. Despite this, foot function is rarely assessed early, and most treatments focus only on managing complications after they appear. This study is important because it focuses on prevention rather than cure. By comparing foot function in people with and without diabetes, we can identify early signs of weakness before they turn into bigger problems. Simple steps like foot exercises, balance training, and better footwear could make a big difference. With diabetes cases rising fast in India, early detection and care can help people stay mobile, independent, and live healthier lives.

 

AIM 

 

 To evaluate the foot core system in people with Type 2 diabetes, to identify early changes. 

 

METHODOLOGY 

 

 Nature of study: Cross Sectional Study 

 Study Population: The study includes individuals diagnosed with Type 2 diabetes mellitus. 

 Sample size: 100 Type 2 diabetic population. (by solvins formula) 

 Sampling method: Convenience Sampling 

 Study setting: Physiotherapy OPD (Amar Jyoti Hospital), Diabetic clinics.

 Material required: Card, Markers, Paper, Pen, Chair, GateON software-ohm 3000 plantar pressure system, towel, handheld dynamometer.

 

SAMPLING CRITERIA

 

 INCLUSION CRITERIA 

 1. Individuals aged 40–60 years.

 2. Both gender

 3. Individuals Diagnosed with Type 2 diabetes mellitus (T2DM) for at least 5 years according to WHO criteria (fasting blood glucose greater than126 mg/dL or HbA1c greater than 6.5 percent). 

 

 EXCLUSION CRITERIA 

 1. History of foot ulcers, amputations, or severe foot deformities. 

 2. Ruled out using the Michigan neuropathy screening instrument (MNSI) 

 3. Any neurological or musculoskeletal disorders affecting balance and gait (e.g., stroke, Parkinson’s disease, severe osteoarthritis). 

 4. Use of orthotic insoles or assistive devices that may alter foot function. 

 5. Uncontrolled diabetes (HbA1c greater than9 percent) or any other systemic illness that affects mobility. 

 6. Recent lower limb injury or surgery (within the last 6 months). 

 

OUTCOME MEASURE

 

Passive Subsystem (Foot Posture Assessment)

Navicular Drop Test / Feiss Line (Reliability: 0.914, Côté et al., 2005)

2. Active Subsystem (Intrinsic Foot Muscle Strength Assessment)

(a) Card Test (Validity: ICC 0.795, Reliability: 88%, Chatzistergos PE et al., 2020)

b) Towel Toe Curling Test (Validity: 0.7, Reliability: 95percent, Miller et al., 2014)

3. Neural Subsystem (Foot Stability and Balance Assessment)

Single Leg Stand Test (OLST) (Validity: 0.65, Reliability: 0.87, Jam B., 2013)

4. (a) Ohm 3000 Plantar Pressure System For measuring plantar static pressure  (Reliability: 0.88 to 0.94, Sawant & Vaidya.,2022)

    (b) Hand-held dynamometer 

 

PROCEDURE 

 

 The study will begin with obtaining AJIRB (Amar Jyoti Institutional Review Board) approval, to ensure ethical compliance and adherence to research protocol. This study will proceed with registration under CTRI. The patients diagnosed with type 2 diabetes will undergo a screening process utilizing a researcher developed screening form, and those meeting the inclusion criteria will be informed about the study’s purpose, procedure, risks and benefits of research procedures in detail before providing their consent. Data collection sheets will take place by the researcher based on the reporting of the subjects. The screening form will be filled by the researcher as per the reporting of the patient. Once data is collected, data compilation will do in MS Excel sheet. Finally, compiled data will be analyzed using SPSS Software. 

 

DATA ANALYSIS 

 Data from this study will be compiled in a Microsoft Excel sheet and it will be analyzed on SPSS version 23.0. The demographics of the subject will be analyzed by descriptive statistics 

 

 

 
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