| 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
|
|
|
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
|
|
|
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.. |