Tibial Nerve Mobilization Versus Multisensory Exercises in Patients With Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
The purpose of this study is to compare the effects of Tibial Nerve Mobilization and Multisensory Exercises on balance, quality of life, neuropathy severity and healing in patients with Diabetic Foot Ulcers. The aim is to identify the more effective intervention, which could help improve pain management, foot biomechanics, balance , mechanical loading , enhance blood circulation , nerve function, and promote physical rehabilitation outcomes for these patients. The more effective intervention may lead to a better quality of life, increased independence, and less post-operative discomfort for the patients. For healthcare providers, this could assist in optimizing rehabilitation plans, making them more cost-effective, and reducing the need for extended hospital stays or long-term care.
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
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 55-75 years
- •Diagnosed cases of Type 2 Diabetes Mellitus by clinical and laboratory tests.
- •Both male and female participants.
- •Grade 0 and Grade 1 diabetic foot ulcers, as classified by the Wagner Ulcer Classification.
- •Participants must have poor glycemic control according to HbA1c ≥ 7.5 % or Fasting Blood Glucose ≥ 130 mg/dl or Random Blood Glucose ≥ 200 mg/dl.
- •Patient with healed ulcer or in last stage of healing duration >1 to 2 weeks
- •Absence of active infection.
- •No cognitive impairments that would affect participation.
- •Diabetes duration of less than 10 years.
- •Able to perform the exercises and participate in physical therapy sessions.
- •No history of amputation above the metatarsophalangeal joint.
排除标准
- •Presence of other systemic diseases apart from diabetes, such as autoimmune diseases or rheumatoid arthritis.
- •Foot ulcers that are classified as Grade 2 or higher using the Wagner Ulcer Classification.
- •Recent fractures, or trauma leading to nerve injuries in the last year.
- •Neurological disorders including Parkinson's disease, stroke, multiple sclerosis, or neuropathy from other causes.
- •Visual impairments or cognitive disorders that could affect participation.
- •History of recent vascular complications, surgical procedures for lower limbs in the last 6 months, or amputation above the metatarsophalangeal joint.
- •Severe DPN with Michigan Diabetic Neuropathy Score (MDNS) above 30, or abnormal nerve conduction studies.
- •Pregnancy or unwillingness to participate.
研究组 & 干预措施
Tibial Nerve Mobilization
干预措施: Tibial Nerve Mobilization (Behavioral)
Multisensory Exercises
干预措施: Multisensory exercises (Behavioral)
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: Baseline and immediately after 4 weeks of intervention
The Berg Balance Scale (BBS) is a commonly used clinical scale for assessing static and dynamic balance in sitting and standing. It consists of 14 functional balance items that assess the ability to maintain positions and perform postural adjustments during functional movements. Each item is scored from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance performance. The BBS has demonstrated high reliability and good validity for assessing balance.
次要结局
- Short Form-12 Health Survey (SF-12)(Baseline and immediately after 4 weeks of intervention)
- SINBAD Scoring System:(Baseline and immediately after 4 weeks of intervention)
- Toronto Clinical Neuropathy Score (TCNS)(Baseline and immediately after 4 weeks of intervention)