Effects of Task Oriented Training on Balance With or Without Textured Insoles in Patient With Peripheral Diabetic Neuropathy."
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- balance measured by the berg balance scale
研究概览
简要总结
Introduction Peripheral diabetic neuropathy (PDN) is a common complication of diabetes that can cause sensory impairment, poor balance, and increased risk of falls. Task-oriented balance training may improve functional balance, while textured insoles may provide additional sensory input from the feet. However, limited evidence is available regarding the combined effect of these interventions in patients with PDN.
Objective The objective of this study is to determine the effect of task-oriented balance training with and without textured insoles on balance, functional mobility, and foot pain in patients with peripheral diabetic neuropathy.
Methodology This randomized controlled trial will include 28 participants, randomly divided into Group A (n=14) and Group B (n=14). Group A will receive task-oriented balance training without textured insoles, while Group B will receive task-oriented balance training with textured insoles. The intervention will be provided for 4 weeks, 3 days per week.
Pre- and post-intervention assessments will be performed using the Berg Balance Scale (BBS), Timed Up and Go (TUG), and Visual Analog Scale (VAS). The Michigan Neuropathy Screening Instrument (MNSI) will be used as a screening tool.
Data will be analyzed using SPSS version 25. Descriptive statistics will include mean, standard deviation, frequencies, and percentages. Normality will be assessed using the Shapiro-Wilk test. Appropriate parametric or non-parametric tests will be used for within- and between-group comparisons.
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 (Participant)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female. Aged 30 to 75 . Pre-diagnosed diabetic peripheral neuropathy due to type 2 diabetes by physician.
- •Able to walk independently. Willing to wear insoles
排除标准
- •Foot ulcers. Structured deformities in lower limb. Use of medications that affecting balance. Any neurological condition other than peripheral diabetic neuropathy. Any musculoskeletal disorder that affects balance.
研究组 & 干预措施
group A task oriented training
The exercises in the Group A were structured task-oriented training program which is as follows:
- Sit-to-Stand Training:
- Tandem Standing.
- Obstacle Walking.
- Step-Up and Step-Down Training.
- Weight-Shifting Training.
- Single-Leg Standing.
- Walking Training.
- Reaching Activities. Each participant was performing these exercises for three to five sessions per week for 6 weeks, with each session lasting between 30 and 40 minutes.
干预措施: Task oriented balance training (Behavioral)
group B task oriented training with textured insoles
The Group B participants received the same training program as Group A, which was task oriented, but under the same frequency, duration and supervision. Furthermore, the participants in the experimental group wore textured insoles in their normal shoes during the task-oriented training sessions. The rationale for the raised nodular texture was to provide sensory feedback, proprioceptive input, and postural control and balance performance improvements for individuals with peripheral diabetic neuropathy. Wearing insoles 6hours/day for 6days/week.
- Sit-to-Stand Training:
- Tandem Standing.
- Obstacle Walking.
- Step-Up and Step-Down Training.
- Weight-Shifting Training.
- Single-Leg Standing.
干预措施: Task oriented balance training (Behavioral)
group B task oriented training with textured insoles
The Group B participants received the same training program as Group A, which was task oriented, but under the same frequency, duration and supervision. Furthermore, the participants in the experimental group wore textured insoles in their normal shoes during the task-oriented training sessions. The rationale for the raised nodular texture was to provide sensory feedback, proprioceptive input, and postural control and balance performance improvements for individuals with peripheral diabetic neuropathy. Wearing insoles 6hours/day for 6days/week.
- Sit-to-Stand Training:
- Tandem Standing.
- Obstacle Walking.
- Step-Up and Step-Down Training.
- Weight-Shifting Training.
- Single-Leg Standing.
干预措施: task oriented training with textured insoles (Other)
结局指标
主要结局
balance measured by the berg balance scale
时间窗: The balance assessment is done pre treatment on day 1 week 1 before 1st session and second assessment is done on 12th session after 4 weeks]
Balance will be assessed using the Berg Balance Scale (BBS), a validated 14-item clinical tool used to evaluate functional balance and risk of falls. The scale assesses static and dynamic balance during functional tasks such as sitting, standing, transfers, turning, and reaching. Higher scores indicate better balance performance.
次要结局
- visual analogue scale to assess foot pain(The pain assessment is done pre treatment on day 1 week 1 before 1st session and second assessment is done on12th session after 4 weeks])
研究者
Ayesha Rashid
Dr. Ayesha Rashid PT
Superior University