Efficacy of a Structured Multisensory Re-education Program on Sensory Function and Upper Limb Sensorimotor Performance in Individuals With Diabetic Peripheral Neuropathy.

Официальное название

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.

Обзор

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.

Подробное описание

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.

Primary outcomes include sensory function performance, Modified Total Neuropathy Score (mTNS), thermal sensory thresholds, Semmes-Weinstein Monofilament Test, vibration perception threshold, joint position sense, two-point discrimination, and neuropathy-related quality of life. Secondary outcomes include Nine-Hole Peg Test and Grooved Pegboard Test performance.

The findings of this study are expected to provide evidence regarding the role of multisensory sensory rehabilitation in improving sensory recovery and upper-limb function in individuals with Diabetic Peripheral Neuropathy.

Вмешательства

• Поведенческое Structured Multisensory Re-education Program
  A structured multisensory re-education program targeting sensory deficits in individuals with diabetic peripheral neuropathy. The program includes tactile, thermal, vibration, proprioceptive, and sensory discrimination training delivered twice weekly for five weeks.
• Поведенческое Behavioral: Sham Sensory Exposure
  Participants in the sham control group will receive passive sensory exposure sessions without structured sensory re-education, active sensory discrimination training, feedback, or progression of sensory tasks. The duration and frequency of sessions will be matched to the experimental group.

Первичные конечные точки

• Composite Sensory Function Score Measured Using Quantitative Sensory Testing (QST) [Срок оценки: Baseline and Post-intervention (5 Weeks)]

Вторичные конечные точки (4)

• Neuropathy Severity Measured by the Modified Total Neuropathy Score (mTNS) [Срок оценки: Baseline and Post-intervention (5 Weeks)]
• Upper Limb Dexterity Measured by the Nine-Hole Peg Test (9HPT) [Срок оценки: Baseline and Post-intervention (5 Weeks)]
• Manual Dexterity Measured by the Grooved Pegboard Test (GPT) [Срок оценки: Baseline and Post-intervention (5 Weeks)]
• Neuropathy-Related Quality of Life Measured by Neuropathy-Specific Quality of Life Questionnaire [Срок оценки: Baseline and Post-intervention (5 Weeks)]

Критерии участия

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.

Критерии исключения

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.

Pregnancy.

Inability to comply with study procedures or follow-up assessments.n Criteria:

Критерии исключения

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07670598 · SENS-UL-DPN-RCT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗