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临床试验/CTRI/2025/07/091197
CTRI/2025/07/091197尚未招募不适用

Quantifying The Impact Of Diabetic Peripheral Sensory Dysfunction On Neural Mobility Gait Speed And Balance Performance

未提供1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年8月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
62
试验地点
1
主要终点
Two-point discrimination test useing aesthesiometer

研究概览

简要总结

The study titled "Quantifying the Impact of Diabetic Peripheral Sensory Dysfunction on Neural Mobility, Gait Speed, and Balance Performance" aims to explore how sensory impairments associated with Type 2 Diabetes Mellitus (T2DM) affect physical performance and neural function. Diabetes mellitus is known to cause long-term complications, particularly affecting the nervous system, resulting in peripheral diabetic neuropathy (PDN) in 30–50% of patients. These complications manifest as sensory and motor dysfunctions such as reduced tactile discrimination, altered proprioception, muscle weakness, and impaired gait and balance. The study employs a cross-sectional design with 62 participants diagnosed with T2DM for more than two years but without clinically diagnosed DPN. Participants will undergo a series of assessments including two-point discrimination using an aesthesiometer, Semmes Weinstein monofilament testing for foot sensitivity, a 10-meter walk test for gait speed, neural mobility tests focusing on the tibial and sural nerves, and the Balance Error Scoring System (BESS) for balance evaluation. These measures will help establish correlations between sensory loss and functional impairments in mobility and balance. The study’s significance lies in identifying early sensory deficits that could potentially lead to falls and decreased quality of life, even before full-blown DPN manifests. A detailed review of literature supports the hypothesis that sensory dysfunction due to diabetes impacts gait and balance and that neural mobilization techniques may enhance nerve function and overall mobility. Statistical analysis using Pearson’s correlation will determine the strength of relationships between sensory impairment and the measured physical performance outcomes. This research could provide a basis for preventive and rehabilitative strategies in diabetic individuals, emphasizing early detection and targeted physiotherapy interventions to maintain functional independence and reduce fall risk. Ethical clearance, informed consent, and non-invasive procedures ensure the study’s scientific and ethical integrity. By linking peripheral sensory dysfunction with neural dynamics and movement outcomes, this research hopes to contribute meaningfully to the management of diabetic complications.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Individuals having type 2 diabetes more than 3 years and less than 10 year;Individuals with undetected peripheral neuropathy(DPN);Consent to participate in the study;Able to walk without assistive device.

排除标准

  • Previously diagnosed Diabetic neuropathy; Any other neurological disease causing neuropathy or cardiovascular disorders; Any low back related condition causing nerve deficit; Hypomobile or hypermobile lower limb joints; Open foot ulcers or wound; Congenital or acquired deformities of lower limb; Recurrent dizziness and vertigo; History of amputation; Unwilling to participate in the study.

结局指标

主要结局

Two-point discrimination test useing aesthesiometer

时间窗: After recruitment | Time point 0-Two point discrimination | Time point 1-Monofilament testing | Time point 2- 10 Meter walk test | Time point 3- BESS | Time point 4- Neural mobility test | T0-5min,T1-5min,T2-10min,T3-10min,T4-5min

Semmes Weinstein monofilament testing

时间窗: After recruitment | Time point 0-Two point discrimination | Time point 1-Monofilament testing | Time point 2- 10 Meter walk test | Time point 3- BESS | Time point 4- Neural mobility test | T0-5min,T1-5min,T2-10min,T3-10min,T4-5min

10 Meter Walk test

时间窗: After recruitment | Time point 0-Two point discrimination | Time point 1-Monofilament testing | Time point 2- 10 Meter walk test | Time point 3- BESS | Time point 4- Neural mobility test | T0-5min,T1-5min,T2-10min,T3-10min,T4-5min

Balance Error Scoring System

时间窗: After recruitment | Time point 0-Two point discrimination | Time point 1-Monofilament testing | Time point 2- 10 Meter walk test | Time point 3- BESS | Time point 4- Neural mobility test | T0-5min,T1-5min,T2-10min,T3-10min,T4-5min

Neural Mobility test –Tibial nerve and Sural nerve Mobility test

时间窗: After recruitment | Time point 0-Two point discrimination | Time point 1-Monofilament testing | Time point 2- 10 Meter walk test | Time point 3- BESS | Time point 4- Neural mobility test | T0-5min,T1-5min,T2-10min,T3-10min,T4-5min

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Amratha G Shetty

ALVAS COLLEGE OF PHYSIOTHERAPY

研究点 (1)

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