NCT07712289已完成不适用
Comparative Analysis Between Textured Insoles and Roods Facilitatory Technique Affecting Balance in Patients With Diabetic Neuropathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- BBS
研究概览
简要总结
The purpose of this randomized controlled trial is to compare the effectiveness of textured insoles versus Rood's facilitatory technique in improving balance in patients with diabetic neuropathy. The study aims to answer the following question: What is the comparative analysis between textured insoles and Rood's facilitatory techniques affecting balance in patient with diabetic neuropathy?
Participants assigned into two groups. Group A received contrast bath plus Rood's facilitatory techniques, while Group B received contrast bath plus textured insoles. Treatment will be delivered over a four-week period, with three sessions per week on alternative days.
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
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a clinical diagnosis of Type 2 diabetes.
- •Participants must show evidence of diabetic peripheral neuropathy (DPN) as diagnosed by clinical examination.
- •Participants with 25-40 Berg Balance Score.
- •Participants with 6-8(Patient version) and 2.5-4(Physical assessment) Michigan Neuropathy Score.
- •Participants aged 45 years to
- •Participants taking medications.
- •Participants must be able to understand the study procedures and provide written informed consent.
排除标准
- •Participants who have significant cognitive impairments (e.g., dementia) that would prevent them from understanding and adhering to study instructions.
- •Participants with severe PAD or significant circulatory problems that would contraindicate the use of insoles or tactile stimulation therapy.
- •Participants with other neurological conditions that could confound the results.
- •Participants who have had recent surgery or trauma to the feet or lower extremities in the past 6 months.
- •Participants who are involved in another clinical trial.
- •Participants with active diabetic foot ulcers, severe deformities, infections, or other complications that would make it unsafe or inappropriate to use textured insoles.
结局指标
主要结局
BBS
时间窗: Four weeks
Berg Balance Scale
次要结局
- MNSI(Four weeks)
研究者
研究点 (1)
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