Comparison of Proprioceptive Neuromuscular Training and Sensory Re-education in Patients With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Balance Performance Assessed by the Berg Balance Scale
研究概览
简要总结
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and is associated with sensory loss, impaired proprioception, balance deficits, and altered gait patterns, which significantly increase the risk of falls and functional dependence. Rehabilitation strategies targeting sensory and proprioceptive impairments are essential to improve postural control and mobility in this population.
This randomized controlled trial aims to compare the effects of proprioceptive neuromuscular training and sensory re-education on balance and gait performance in patients with diabetic peripheral neuropathy. Participants diagnosed with DPN will be randomly allocated into two groups. Group A will receive sensory re-education, while Group B will undergo a structured proprioceptive training program. Both groups will also receive baseline conventional treatment.
Balance and gait outcomes will be assessed using the Berg Balance Scale and the Dynamic Gait Index at baseline, mid-intervention, and post-intervention. The findings of this study may help determine the more effective rehabilitation approach for improving balance and gait in individuals with diabetic peripheral neuropathy, thereby reducing fall risk and enhancing functional independence.
详细描述
Diabetic peripheral neuropathy is a progressive complication of diabetes characterized by sensory impairment, proprioceptive deficits, and neuromuscular dysfunction. These impairments adversely affect balance control and gait stability, increasing the likelihood of falls, injuries, and reduced quality of life. Despite the widespread use of rehabilitation interventions, there is limited comparative evidence regarding the effectiveness of sensory re-education versus proprioceptive neuromuscular training in improving functional outcomes among individuals with DPN.
This randomized controlled trial will be conducted at the University Institute of Physical Therapy, Lahore, following approval from the Institute Research Ethics Board. Eligible participants with confirmed diabetic peripheral neuropathy will be recruited through referrals from endocrinologists and diabetologists. After obtaining informed consent, participants will be randomly assigned to either the sensory re-education group or the proprioceptive training group using a lottery method. The study will follow a single-blinded design, with outcome assessors blinded to group allocation.
Both groups will undergo a six-week intervention program consisting of three supervised sessions per week. Balance and gait performance will be evaluated at baseline, at the third week, and at the completion of the intervention using standardized outcome measures. Data analysis will focus on comparing within-group and between-group changes over time.
The results of this study are expected to provide evidence-based guidance for physical therapists in selecting effective rehabilitation strategies to improve balance and gait in patients with diabetic peripheral neuropathy, ultimately aiming to reduce fall risk and enhance functional mobility.
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)
盲法说明
Masking Description
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both males and females Diagnosed with Diabetes Mellitus (Type 1 or Type 2) Aged between 40-75 years Presence of diabetic peripheral neuropathy (as confirmed by Michigan Neuropathy Assessment Tool or Toronto Clinical Rating Scale) HbA1c level > 7% consistently over the last 6 months
排除标准
- •Unable to ambulate independently or with assistance Any history of neurological disorders Any history of musculoskeletal disordersin the past 6 months Renal and liver failure History of Ischemic heart disease History of dizziness or balance-impairing conditions
研究组 & 干预措施
group A Sensory Re-Education
Participants in this group will receive a structured sensory re-education program for six weeks, with three sessions per week. Each session will include 10 minutes of electrical muscle stimulation (EMS) applied to the lower lumbar region and area of neuropathic discomfort. Sensory re-education will involve stroking the affected skin using brushes and various textured materials, progressing from rough to soft textures over five minutes per session. Balance and gait will be assessed using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) at baseline, mid-intervention, and post-intervention.
干预措施: Sensory Re-Education Program (Behavioral)
group B Proprioceptive Neuromuscular Training
Participants in this group will undergo a structured proprioceptive neuromuscular training program for six weeks, with three sessions per week. Each session will start with 10 minutes of electrical muscle stimulation (EMS) applied to the lower lumbar region and area of neuropathic discomfort. The main intervention will include balance exercises (bilateral stance, heel raises, single-leg stance with hip flexion, eyes open and closed), strengthening exercises targeting lower limb muscles (quadriceps, hamstrings, lateral thigh), plyometric exercises (single- and double-leg jumps with rotations), and agility drills (figure-eight and directional movements). Each session lasts approximately 30 minutes, and exercises will progress in intensity and complexity based on participant tolerance. Balance and gait outcomes will be measured using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) at baseline, mid-intervention, and post-intervention.
干预措施: Proprioceptive Neuromuscular Training (Behavioral)
结局指标
主要结局
Balance Performance Assessed by the Berg Balance Scale
时间窗: Baseline, 3 weeks, and 6 weeks after the start of intervention
The primary outcome is the change in balance performance in patients with diabetic peripheral neuropathy. Balance will be measured using the Berg Balance Scale (BBS), a validated tool consisting of 14 tasks evaluating both static and dynamic balance, scored from 0 (lowest function) to 4 (best performance), with a total maximum score of 56. Higher scores indicate better balance and mobility. Assessments will be conducted at baseline, at 3 weeks, and at 6 weeks post-intervention.
次要结局
未报告次要终点
研究者
Montiha Azeem
principal investigator
University of Lahore