Comparative Analysis Between Textured Insoles and Roods Technique Affecting Balance in DNP. (DNP)
Comparative Analysis Between Textured Insoles and Roods Facilitatory Technique Affecting Balance in Patients With Diabetic Neuropathy
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Punjab Province
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Faisalābad、Punjab Province、巴基斯坦、38000
- The University of Faisalabad
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria
- 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 60.
- Participants taking medications.
- Participants must be able to understand the study procedures and provide written informed consent.
Exclusion Criteria
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Group A
Group A received contrast bath plus Rood's facilitatory techniques.
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Quick stretch and Heavy compression technique targeted areas of lower extremities
|
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有源比较器:Group B
Group B received contrast bath plus textured insoles.
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Participants wore allocated insoles, in their own shoes, as much as possible.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
BBS
大体时间:Four weeks
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Berg Balance Scale
|
Four weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
MNSI
大体时间:Four weeks
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Michigan Neuropathy Screening Instrument
|
Four weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- TUF/IRB/96/2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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