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临床试验/CTRI/2025/03/082188
CTRI/2025/03/082188已完成不适用

IMPACT OF LOWER LIMB MUSCLE STRENGTH ON FORWARD REACTIVE STEPPING IN DIABETIC PATIENTS

Sri Ramachandra Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年3月24日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
First step length- the distance covered with the first step after initiating movement, indicating how far the body progresses with the first stride.

研究概览

简要总结

Diabetes mellitus (DM) impairs blood glucose regulation, affecting multiple body systems and

often leading to muscle weakness, balance issues, and increased fall risk. Balance in individuals with diabetes is impacted by factors such as muscle weakness, plantar insensitivity, and proprioception deficits, which all contribute to diminished stability and compensatory abilities. While common balance assessments like the Berg Balance Scale and Timed Up and Go Test focus primarily on anticipatory postural control, they lack in assessing reactive balance—a critical component for fall prevention. The Balance Evaluation Systems Test (BESTest), however, measures reactive compensatory stepping, which is especially relevant for diabetes-related balance deficits.This observational study aims to explore how lower extremity muscle strength affects forward reactive stepping ability in diabetic patients, a vital skill for maintaining stability in unexpected balance disruptions. Using the BESTest’s lean-and-release method, the study will measure reactive balance responses, while muscle strength will be assessed with a handheld dynamometer, focusing on hip abductors, knee extensors, and ankle plantarflexors. The relationship between muscle strength and forward stepping metrics, including step time, step distance, and recovery time, will be analysed.Participants will include Type 1 and 2 diabetic patients aged 30 to 60 years, with a diabetes duration of 3-5 years, no severe foot complications, and independent mobility. Findings from this study aim to fill a gap in understanding the role of

muscle strength in reactive balance control, providing valuable insights for improving balance assessment and fall prevention strategies for diabetic individuals.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Diabetic patients of both genders, aged 45 to 60 years Diagnosed with Type 1 and 2 diabetes mellitus for at least 3 to 5 years Able to walk independently without assistive devices.
  • No history of major foot complications, such as amputations or severe ulcers.

排除标准

  • Neurological conditions (e.g., stroke, Parkinson’s disease) that independently affect balance.
  • Diabetic Neuropathy Use of medications that severely affect muscle strength or coordination.
  • Any orthopedic condition that limits mobility (e.g., recent lower limb surgery or severe arthritis).

结局指标

主要结局

First step length- the distance covered with the first step after initiating movement, indicating how far the body progresses with the first stride.

时间窗: At the time of evaluation

First step time - the duration taken to complete the first step, indicating the speed at which the first step is performed.

时间窗: At the time of evaluation

Balance recovery distance is the distance the body moves or shifts to regain stability after losing balance.

时间窗: At the time of evaluation

Muscle strength in kilograms in a dynamometer for plantar flexors (PF), hip abductors, and knee extensors refers to the maximum force exerted by these muscle groups, measured in kilograms using a handheld device (dynamometer).

时间窗: At the time of evaluation

次要结局

  • Screening for Diabetic Neuropathy(At the time of evaluation)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Charulatha K

SRIHER

研究点 (1)

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