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临床试验/CTRI/2025/09/094710
CTRI/2025/09/094710尚未招募不适用

Evaluation of the foot core system in type 2 diabetic population

Rahul kumar gond1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
3.Towel Toe Curling Test

研究概览

简要总结

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)

  1. 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)

  1. Neural Subsystem (Foot Stability and Balance Assessment)

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

  1. (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

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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).

排除标准

  • History of foot ulcers, amputations, or severe foot deformities.
  • Ruled out using the Michigan neuropathy screening instrument (MNSI)
  • Any neurological or musculoskeletal disorders affecting balance and gait (e.g., stroke, Parkinson’s disease, severe osteoarthritis).
  • Use of orthotic insoles or assistive devices that may alter foot function.
  • Uncontrolled diabetes (HbA1c greater than 9 percent) or any other systemic illness that affects mobility.
  • Recent lower limb injury or surgery (within the last 6 months).

结局指标

主要结局

3.Towel Toe Curling Test

时间窗: Baseline

1 Navicular Drop Test

时间窗: Baseline

2.Card Test

时间窗: Baseline

4.One Leg Stand Test (OLST)

时间窗: Baseline

5.Ohm 3000 Plantar Pressure System.

时间窗: Baseline

6.Hand- held dynamometer.

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Rahul kumar gond
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rahul kumar gond

AmarJyoti institute of physiotherapy

研究点 (1)

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