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CTRI Number  CTRI/2025/08/093252 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of biomechanics of foot and walking parameters in young diabetes patients 
Scientific Title of Study   Assessment Of Foot Biomechanics And Gait Parameters Among Individuals With Young-Onset Type 2 Diabetes Mellitus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mahantesh L 
Designation  Postgraduate Student MPT 
Affiliation  Manipal College of Health Professionals 
Address  Department of Physiotherapy room no 215 second floor Manipal College Of Health Professions Manipal Academy of Higher Education Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9148385511  
Fax    
Email  mahantesh.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr. G Arun Maiya 
Designation  Dean & Professor 
Affiliation  Manipal College of Health Professionals 
Address  Department of Physiotherapy room no 215 second floor Manipal College Of Health Professions Manipal Academy of Higher Education Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ms Tina Agnes 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professionals 
Address  Department of Physiotherapy room no 215 second floor Manipal College Of Health Professions Manipal Academy of Higher Education Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9740688454  
Fax    
Email  tina.agnes@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal, Udupi, Karnataka 
 
Primary Sponsor  
Name  Dr Mahantesh L PT 
Address  Department of Physiotherapy room no. 215, second floor Manipal College Of Health Professions Manipal Academy of Higher Education Manipal Udupi 
Type of Sponsor  Research institution and hospital 
 
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 Mahantesh L PT  Kasturba Hospital  Room no 1, center for Podiatry and diabetic foot care and research, Department of Physiotherapy, N1, Kasturba Hospital, Manipal.
Udupi
KARNATAKA 
9148385511

mahantesh.mchpmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Young adults with confirmed diagnosis of Type 2 Diabetes Mellitus.
2. Duration of diabetes: At least 1 year since diagnosis.
3. Ability to walk independently without assistive devices
 
 
ExclusionCriteria 
Details  1. Participants with any congenital foot deformities, Vasculopathy, orthopedic or neurological disorders affecting mobility.
2. Participants with active foot ulcers and history of major foot surgeries or amputations
3. Participants with Gestational diabetes
•Pregnant women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Foot posture
2. Medial longitudinal arch height
3. Static and Dynamic plantar pressure parameters
 
single time point (at the time of recruitment) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="111"
Sample Size from India="111" 
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)   06/09/2025 
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="8"
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  

 Eligible participants diagnosed with young-onset type 2 diabetes mellitus (YOD) will be identified and provided with detailed information about the study. Those willing to participate will be given an information sheet and required to sign a written consent form prior to their inclusion. Following consent, participants will undergo assessments for diabetic peripheral neuropathy (DPN), vascular health, footwear assessment and musculoskeletal flexibility, along with clinical tests such as the Windlass Test, Jack Test, Navicular Drop Test, and Foot Posture Index (FPI). Static and dynamic plantar pressure scans will also be performed.

Consenting participants shall be included in the study. Procedure will be explained to participants. Demographic characteristics will be collected from participants. Basic demographic details, including age, gender, height, weight, duration of diabetes. Participants will be screened for significant comorbidities that might affect gait or foot biomechanics. The screening for neuropathy will include the use of the 10g Semmes-Weinstein monofilament and the biothesiometer. The monofilament test will be performed at specific plantar sites, such as the hallux and metatarsal heads, by gently applying the filament until it bends slightly. The participant will indicate when the sensation is felt, and failure to detect the filament at two or more sites will indicate sensory loss. Vibration perception will be assessed using a biothesiometer applied to the great toe and medial malleolus, with the participant reporting the point of sensation. Vibration thresholds exceeding 25 Volts will suggest potential neuropathy. Vasculopathy assessment will involve calculating the Ankle-Brachial Index (ABI). Systolic blood pressure will be measured at the brachial artery and either the dorsalis pedis or posterior tibial artery using an analog sphygmomanometer. The ABI will be determined by dividing the ankle systolic pressure by the brachial systolic pressure. An ABI value below 0.9 will indicate peripheral arterial disease, while a value exceeding 1.3 will suggest vascular stiffness. Hamstring flexibility will be assessed through the passive straight leg raise test.. Gastrocnemius Tightness assessed by measuring ankle dorsiflexion with the knee extended. Hip Flexor Tightness evaluated using the Modified Thomas test. Adductor Tightness assessed using a side-lying adductor flexibility test. The participant will lie on their side, and the upper leg will be passively abducted to evaluate the range of motion. Tightness will be noted if there is a restricted range or discomfort. Footwear assessment will examine size, fit, wear patterns, material flexibility, and cushioning. Ill-fitting or worn-out footwear will be documented as potential contributors to biomechanical deviations or discomfort. The Windlass Test evaluates the integrity of the plantar fascia and its function during weight-bearing activities. The participant will be positioned standing on a step with the toes of one foot placed over the edge while the other foot remains flat on the ground for support. The examiner will passively extend the participant’s great toe while observing the arch. A positive test, indicated by pain or limited arch elevation during toe extension, suggests plantar fascia dysfunction or tightness. The Jack Test, also known as the "Hubscher Maneuver," assesses the mobility of the first metatarsophalangeal joint and the ability of the foot arch to respond dynamically. The participant will stand barefoot with equal weight distribution. The examiner will dorsiflex the great toe while observing the medial longitudinal arch. A normal response is arch elevation during dorsiflexion, while a lack of movement may indicate flatfoot or functional arch dysfunction. The “Navicular Drop Test” measures the flexibility of the medial longitudinal arch by assessing the displacement of the navicular bone during weight-bearing. The participant will be seated with the feet flat on the ground, and the examiner will mark the position of the navicular tuberosity using a marker. This height is measured with a ruler. The participant will then stand, and the navicular height will be re-measured under weight-bearing conditions. The difference between the two measurements indicates the extent of arch flexibility, with excessive drop suggesting a hypermobile or pronated foot. The Foot Posture Index (FPI) is a detailed evaluation tool designed to determine foot type by analyzing six specific parameters: the palpation of the talar head, the curvature above and below the lateral malleolus, the calcaneal position in the frontal plane, the prominence of the talonavicular joint, the height of the medial longitudinal arch, and the forefoot’s abduction or adduction. Each parameter is rated on a scale from -2 to +2, where negative scores signify supination, and positive scores indicate pronation. During the assessment, participants are barefoot and stand in a relaxed posture, allowing the examiner to visually and manually assess each criterion. The overall FPI score categorizes the foot as highly supinated, supinated, neutral, pronated, or highly pronated.

Plantar pressure distribution will be assessed using the Gaitchecker platform. For static analysis, participants will stand barefoot on the platform, while for dynamic analysis, they will walk barefoot at a comfortable pace, ensuring a minimum of two complete gait cycles are recorded. The system will provide data on pressure distribution, peak plantar pressures, and gait parameter. The whole evaluation duration will take approximately 1 hour and will happen in single visit..

 
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