Effectiveness of Foot Exercise Training on Patients With Type 2 Diabetes and Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pain assessment with Algometry
研究概览
简要总结
The aim of this study will to investigate the effect of foot exercises in patients with type 2 diabetic and peripheral neuropathy. Subjects will be randomly allocated to either the control or intervention group. Data will be collected using investigator-developed forms: patient information form and the diabetic foot exercises log. Patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks; the control group will be received standard treatment but no exercises. The intervention and control groups will be examined and measured at the 4th and 8th weeks.
详细描述
Purpose of our study investigation of the effects foot exercises in patients with type 2 diabetic and peripheral neuropathy.
Excepted results: Routine treatment + foot exercises pain, flexibility, edema, muscle strength, sensation, quality of life we believe that there will be good progress in peripheral neuropathy effects, Leeds assessment of neuropathic symptoms and signs(LANSS) results.
In this context, it is planned that patients randomly divided into 2 groups. Group 1 control group. Group 2 intervention group. Patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks. The patients will be evaluated by clinical measurements and scales based on patient notification at the 4th and 8th weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having type 2 diabetes mellitus for 5 years
- •HbA1c > among of between 6.5-10
- •Having grade 0 or 1 phase of Wagner classification
- •Diabetic neuropathy score ≥ 3
排除标准
- •Not to know turkish
- •Having hearing, visual and speaking problems
- •Having (except diabetic neuropathy) other neurologic problems
- •Having psychiatric and cognitive problems
- •Having orthopedic, rheumatologic, cardiac, and pulmonary problems which stopping exercise
结局指标
主要结局
Pain assessment with Algometry
时间窗: Change from Baseline Pain at 8 weeks
An instrument for determining sensitivity to pain produced by pressure.
Pain assessment With Visual Analog Scale
时间窗: Change from Baseline Pain at 8 weeks
Participants are asked to mark the point where they feel their pain on a 10 centimeter (cm) horizontal line. 0-no pain, 10-unbearable pain. Night, activity and pain conditions are evaluated separately at rest.
Pain assessment with The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
时间窗: Change from Baseline Pain at 8 weeks
The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale evaluates sensory dysfunction and whether the pain is caused by neuropathic mechanisms or not. The LANSS comprises a 5-item questionnaire regarding pain symptoms and two items for clinical signs involving self-administered sensory tests for the presence of allodynia and decreased sensation to pinprick. Responses to each item are binary (yes or no) and each item is weighted differently depending on the odds ratio of a positive response to each item to predict that the pain is primarily neuropathic. The possible scores range from 0 to 24, with a score of 12 or greater considered to be suggestive of neuropathic pain
次要结局
- Muscle Strength with Hand held dynamometer(1th day, 8th week)
- Range Of Motion with goniometer(1th day, 8th week)
- Baseline Tactile Semmes-Weinstein Monofilament(1th day, 8th week)
- Edema measurement of tape(1th day, 8th week)
- Two Point Discrimation Test(1th day, 8th week)
- The Foot and Ankle Ability Measure(1th day, 8th week)
- HbA1c(1 th day, 8th week)
- Serum creatinine(1 th day, 8th week)
- Evaluation of functional capacity with 6 minutes walking test(1th day, 8th week)
- Albumin levels(1 th day, 8th week)
研究者
Evrim KOÇARSLAN
physiotherapist
Istanbul University