Efficacy of a Structured Multisensory Re-education Program on Sensory Function and Upper Limb Sensorimotor Performance in Individuals With Diabetic Peripheral Neuropathy: A Randomized Sham-Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 59
- 主要终点
- Composite Sensory Function Score Measured Using Quantitative Sensory Testing (QST)
研究概览
简要总结
Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes that can cause impairments in sensation, dexterity, and upper-limb function. Current treatment approaches mainly focus on symptom management and glycemic control, while interventions specifically targeting sensory recovery remain limited.
This randomized sham-controlled trial aims to evaluate the effectiveness of a Structured Multisensory Re-education Program (SENS-UL) in improving sensory function and upper-limb sensorimotor performance in adults with DPN. Participants will be randomly assigned to either an intervention group receiving structured multisensory sensory re-education or a sham-control group receiving passive sensory exposure without active sensory retraining.
The intervention will be delivered twice weekly for five weeks. Outcome measures will include sensory function, neuropathy severity, thermal and tactile sensation, vibration perception, proprioception, dexterity, and neuropathy-related quality of life. Assessments will be conducted before and after the intervention period.
The study is expected to provide evidence regarding the effectiveness of multisensory sensory rehabilitation for individuals with DPN and may contribute to the development of targeted rehabilitation strategies aimed at improving sensory recovery, hand function, and quality of life.
详细描述
Diabetic Peripheral Neuropathy (DPN) is one of the most common chronic complications of diabetes mellitus and is associated with sensory loss, impaired sensorimotor performance, reduced functional independence, and decreased quality of life. Although DPN is commonly associated with lower-limb dysfunction, upper-limb sensory impairments may also occur and negatively affect hand function, dexterity, object manipulation, and activities of daily living.
Current management strategies primarily focus on glycemic control, pharmacological symptom management, and general exercise interventions. However, rehabilitation approaches specifically designed to improve sensory function remain limited. Evidence from neurorehabilitation research suggests that sensory re-education interventions may promote neuroplasticity, improve sensory discrimination, enhance cortical sensory processing, and improve functional outcomes.
This study will investigate the efficacy of a Structured Multisensory Re-education Program (SENS-UL Protocol) in adults with clinically confirmed Diabetic Peripheral Neuropathy. The study will use a prospective, parallel-group, participant-blinded, randomized sham-controlled design.
Participants will be recruited from King Fahad Medical City, Riyadh, Saudi Arabia. Eligible participants will be randomly allocated to either an experimental group receiving structured multisensory sensory re-education or a sham-control group receiving passive sensory exposure without active sensory retraining. The intervention will be delivered twice weekly for five weeks, with each session lasting approximately 50-60 minutes.
The intervention includes tactile stimulation, texture discrimination, vibration stimulation, thermal discrimination, localization training, joint position sense training, kinesthesia training, two-point discrimination, stereognosis, barognosis, graphesthesia, and double simultaneous stimulation. The program follows a standardized hierarchical progression model with predefined progression criteria.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •InclusioInclusion Criteria:
- •Adults aged 18 to 75 years. Clinically confirmed diabetic peripheral neuropathy (DPN). Stable medical condition and medication regimen for at least 3 months. Ability to understand study procedures and provide informed consent. Ability to participate in upper-limb sensory and sensorimotor assessments. Willingness to attend all intervention sessions and follow study instructions.
排除标准
- •Other neurological disorders affecting sensory or motor function (e.g., stroke, multiple sclerosis, Parkinson's disease).
- •Severe visual, auditory, or cognitive impairment interfering with participation.
- •Upper-limb musculoskeletal conditions limiting hand function or assessment performance.
- •Active foot ulcer, severe diabetic complications, or unstable medical condition.
- •Participation in another rehabilitation or clinical trial during the study period.
- •Inability to comply with study procedures or follow-up assessments.n Criteria:
- •Exclusion Criteria:
结局指标
主要结局
Composite Sensory Function Score Measured Using Quantitative Sensory Testing (QST)
时间窗: Baseline and Post-intervention (5 Weeks)
Composite sensory function will be assessed using Quantitative Sensory Testing (QST) comprising the Semmes-Weinstein Monofilament Test (SWMT; monofilament level), Vibration Perception Threshold (VPT; Hz), Cold Detection Threshold (°C), Warm Detection Threshold (°C), Joint Position Sense (degrees of reposition error), and Two-Point Discrimination (mm). A standardized composite sensory function score will be calculated from these measures. Higher composite scores indicate better sensory function.
次要结局
- Neuropathy Severity Measured by the Modified Total Neuropathy Score (mTNS)(Baseline and Post-intervention (5 Weeks))
- Upper Limb Dexterity Measured by the Nine-Hole Peg Test (9HPT)(Baseline and Post-intervention (5 Weeks))
- Manual Dexterity Measured by the Grooved Pegboard Test (GPT)(Baseline and Post-intervention (5 Weeks))
- Neuropathy-Related Quality of Life Measured by Neuropathy-Specific Quality of Life Questionnaire(Baseline and Post-intervention (5 Weeks))
研究者
Turki Abualait
Associate Professor, Department of Physical Therapy, Imam Abdulrahman Bin Faisal University
Imam Abdulrahman Al Faisal Hospital