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临床试验/NCT06240910
NCT06240910招募中不适用

Effects of Aerobic Training and Neurodynamics to Prevent Fall and Improve Balance in Patients With Diabetic Neuropathy

Riphah International University4 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
4
主要终点
Berge balance scale

研究概览

简要总结

Diabetes is a group of metabolic diseases, characterized by hyperglycemia resulting from defects in insulin secretion, actionor both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of differentorgans, especially the eyes, kidneys, nerves, heart, and blood vessels. In long standing cases of both diabetes type 1 and 2, about 60 % individuals had diabetic neuropathy. Patients suffering from diabetes are more prone to fall, possibly due to balance issues and sensory ataxia.

详细描述

This study will be a Randomized controlled trial. Participants who have DM2 for past 7 years and who score >2/13 on Michigan neuropathy screening instrument questionnaire with at least 2 DPN symptoms will be screened for this study. Participants with any fracture in lower limb , complete loss of foot perception, comorbidities, using assistive devices and already involved in structured physiotherapy interventional program will be excluded from this randomized controlled trial study. Participants will be selected with non-probability consecutive sampling and will be randomly allocated using computer generated randomizer in two groups i.e., experimental group and control group. Balance and risk of fall will be assessed through Berg Balance scale, functional reach test , Romberg test and morse fall scale before and after giving interventions. Treatment session will be given 3 days a week for 6 weeks. Participants in control group will be given neurodynamics for sciatic nerve ( the total duration of interventions will be approximately 10 minutes a day for 3 days in a week for 6 weeks. Experimental group will be given aerobic exercise interventions (involving warm-up by stretching and flexibility exercisesfor 5 minutes, treadmill walking and stationary bicycle training with 6 minutes a day for 3 days in a week for 6 weeks) along with neural mobilization for sciatic nerve ( 10 minutes a day for 3 days in a week for 6 weeks), so the total duration of interventions for experimental group will be 40-60 minutes a day for 3 days in a week for 6 weeks. Given the high prevalence and substantial impact of diabetic neuropathy on balance and fall risk, it is imperative to explore effective interventions (aerobic exercise + neurodynamics) for managing these impairments. Individuals may experience improved proprioception, enhanced muscle coordination, and optimized neural tissue mobility, leading to reduced fall risk and improved functional independence. Data will be analyze using SPSS 23.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ranged between 45-67 years.
  • Both male and female genders
  • DM for the past 7 years.
  • Scored >2/13 on Michigan neuropathy screening instrument (MNSI) questionnaire including at least two DPN symptoms.

排除标准

  • fracture(s) in the lower limb.
  • Any participant who suffered from foot ulcers.
  • Unstable heart disease, co- Morbid conditions limiting exercise
  • inability of subjects to understand and/or co-operate during quantitative sensory testing or manual/nerve mobility testing and/or treatment.
  • Any level of physical activity i.e 150 minutes/week
  • Receiving any structured supervised physiotherapy interventions.

结局指标

主要结局

Berge balance scale

时间窗: 6 weeks

The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.

次要结局

  • Functional reach test(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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