Effects of Insole Vibration With Proprioceptive Training on Balance and Functional Ability in Patients With Diabetic Peripheral Nuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
Diabetic peripheral neuropathy (DPN) is a prevalent complication of diabetes, profoundly affecting quality of life with sensory disturbances and associated complications. Proprioceptive training shows promise in improving proprioception and functional outcomes in patients with peripheral neuropathy. Also the literature has shown that Insole vibrator demonstrates potential in mitigating symptoms and improving sensory function and balance in patients with peripheral neuropathy. This study aims to determine the effects of insole vibration with proprioceptive training on balance and functional ability in patient with diabetic peripheral neuropathy.
In this randomized controlled trial design, 60 participants will be recruited. The sample size was calculated through G-power total of 60 participants. Who meet the inclusion criteria will be recruited through non-probability convenience sampling technique, which will further be randomized through online randomizer tool into control and experimental group with thirty participants in each group. Experimental group will receive proprioceptive training alongside vibrating insole and control group will receive proprioceptive training with non vibrating insoles. Data will be collected by using various assessment tools, including Numeric Pain Rating Scale for pain,Time Up And Go Test for functional mobility, Neuropathic Disability Score for level of disability ,Functional Reach Test for standing stability, Mini BESTS for balance, functional mobility and gait, Single Leg Stance Test for static posture and balance control and the Montreal Cognitive Assessment for cognitive impairment. Pre-intervention assessments will be conducted for both groups. The effects of the interventions will be measured at pre-treatment, 6th week, 12th week and at 16th week. Data analysis will be performed by using SPSS 26. Mixed ANOVA and repeated-measures ANOVA will use for within-group analysis whereas between-group analysis will perform by using one-way ANOVA.
Key words: Diabetic polyneuropathy, Vibrating insole, proprioceptive training, balance
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients with both genders male and female will be included
- •The age limit for the patients will be from 50 to 70 years
- •Patients diagnosed with DPN type 1 or type 2
- •Patients with neuropathic disability score greater than 3 will be included
- •Patients with Michigan questionnaire higher than 3
- •Patients who can walk independently with BBS score between 41 to 56
排除标准
- •Patients with Mini Mental State less than 24
- •Patients having Numeric Pain Rating Scale greater than 4
- •Patients with any impairment in lower leg e.g; Leg Length Discrepancy, foot ulcer, lower limb injury
研究组 & 干预措施
Group A
Participants in this arm will perform both proprioceptive training exercises and receive insole vibrator.
干预措施: proprioceptive training exercise and receive insole vibrator (Other)
Group B
Participants in this arm will receive only proprioceptive training exercise along with simple insoles without vibration.
干预措施: proprioceptive training exercise along with simple insoles without vibration (Other)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: Baseline after completion of 6 and 8 weeks
to measure pain scale range 0-10. zero means no pain 10 means maximum
Time Up and Go (TUG) Test
时间窗: Baseline after completion of 6 and 8 weeks
To measure mobility and fall risk (time to rise, walk, return) measure in seconds time \> 20 sec means impaired mobility
Neuropathic Disability score (NDS)
时间窗: Baseline after completion of 6 and 8 weeks
Severity of PND (0-10 scale) 0 means no disability 10 means maximum disability
Functional Reach test (FRT)
时间窗: Baseline after completion of 6 and 8 weeks
to measure anticipatory postural control Stability and fall risk
Mini-BESTest
时间窗: Baseline after completion of 6 and 8 weeks
to measure static and dynamic balance (0-30 scale) greater score means better mobility
次要结局
未报告次要终点