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临床试验/NCT07394504
NCT07394504已完成不适用

Effects of Turning Based Dual Task Training on Balance and Mild Cognitive Impairment in Diabetic Peripheral Neuropathy

Foundation University Islamabad1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Balance

研究概览

简要总结

Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes, characterized by impaired sensory and motor function, often leading to balance dysfunction and an increased risk of falls. Additionally, individuals with DPN are at heightened risk for mild cognitive impairment (MCI), which further compromises functional independence. This study aims to determine the effects of turning-based dual-task training compared to conventional dual-task training on balance, cognitive function, and fall risk in individuals with DPN. Pre- and post-intervention assessments will be conducted using the Berg Balance Scale (BBS), Montreal Cognitive Assessment (MoCA), and Timed Up and Go Test (TUGT) to evaluate balance, cognition, and fall risk respectively.

详细描述

Diabetes mellitus (DM) is a chronic metabolic disorder characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. As a major global health concern, its prevalence has been steadily increasing. According to the recent searches, 26.7% of adults in Pakistan are affected by diabetes. Implicated poor glycemic control, duration of diabetes, hyperlipidemia (particularly hypertriglyceridemia), elevated albumin excretion rates and obesity as risk factors for the development of DPN. This study aims to explore the effectiveness of these interventions in this specific population and to tell a treatment that will target both balance and cognition that will be used for DPN patients to improve the symptoms.

A randomized controlled trial will be conducted over one year. 44 participants will be selected through non- probability purposive sampling and randomly divided into two groups. The intervention will last eight weeks, comprising 24 treatment sessions. Assessments will be conducted at baseline and at the end of eight week. Treatment for Group A will include warm up, conventional balance training, turning based dual task training followed by cool down. Group B will include warm up, conventional balance training, dual task training followed by cool down.

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
None

入排标准

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

入选标准

  • Type 2 Diabetes Mellitus ≥ 5 years
  • Diagnosed with Diabetic Peripheral Neuropathy
  • Age 50 and above
  • Berg Balance Scale (BBS 21-40) score
  • Mild Cognitive Impairments (MoCA 18-25)
  • Able to stand and walk with or without assistive devices

排除标准

  • Severe neuropathic foot ulcers or Charcot joints.
  • History of major musculoskeletal injuries affecting ambulation (Fractures of lower limb), Severe Osteoarthritis.
  • Uncontrolled Diabetes.
  • Neurological disorders unrelated to DPN (brain tumors, stroke, epilepsy, Alzheimer's, GBS and Parkinson's disease).
  • Significant visual, auditory impairment.

研究组 & 干预措施

Turning Based Dual-Task Training

Experimental

Group A receives Turning Based Dual-Task Training:

The intervention will be conducted over a total duration of 8 weeks with total of 24 sessions 3 days per week lasting for 30 to 40 minutes. Warm up, Conventional balance training and cool down.

干预措施: Turning Based Dual Task Training (Procedure)

Dual-Task Training

Experimental

Group B receives Dual-Task Training:

The intervention will be conducted over a total duration of 8 weeks with total of 24 sessions 3 days per week lasting for 30 to 40 minutes. Warm up, Conventional balance training and cool down.

干预措施: Dual-Task Training (Procedure)

结局指标

主要结局

Balance

时间窗: 8 weeks

Balance is assessed by Berg Balance Scale. Interpretations: mild=41-56,moderate=21-40,severe=0-20

Cognition

时间窗: 8 weeks

MoCA will be used for mild cognitive impairment. Interpretations: Mild= 18-25, Moderate=10-17, Severe=0-9

Fall Risk

时间窗: 8 weeks

Timed up and go test will be used for Fall Risk. Interpretations: Low Risk: \<10 seconds, Moderate Risk: 10-19 seconds, High Risk: ≥ 14-20 seconds, Severe Risk: \> 30 seconds

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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