Efficacy of a Structured Multisensory Re-education Program on Sensory Function and Upper Limb Sensorimotor Performance in Individuals With Diabetic Peripheral Neuropathy. (SENS-UL)
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.
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
Exclusion Criteria:
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:
Exclusion Criteria:
-
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Multisensory Re-education Group
Participants will receive a structured multisensory re-education program targeting sensory deficits associated with diabetic peripheral neuropathy.
The intervention will be delivered twice weekly for five weeks and will include tactile, thermal, vibration, proprioceptive, and sensory discrimination training.
|
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.
|
|
偽コンパレータ：Sham Control Group
Participants will receive sham sensory exposure sessions without active sensory retraining.
The frequency and duration of sessions will match the experimental group.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Composite Sensory Function Score Measured Using Quantitative Sensory Testing (QST)
時間枠：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.
|
Baseline and Post-intervention (5 Weeks)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neuropathy Severity Measured by the Modified Total Neuropathy Score (mTNS)
時間枠：Baseline and Post-intervention (5 Weeks)
|
Neuropathy severity will be assessed using the Modified Total Neuropathy Score (mTNS).
The mTNS evaluates sensory symptoms, motor symptoms, pin sensibility, vibration sensibility, muscle strength, and deep tendon reflexes.
The outcome measure will be the total mTNS score (points; range 0-24), with lower scores indicating less severe neuropathy.
|
Baseline and Post-intervention (5 Weeks)
|
|
Upper Limb Dexterity Measured by the Nine-Hole Peg Test (9HPT)
時間枠：Baseline and Post-intervention (5 Weeks)
|
Upper limb dexterity will be assessed using the Nine-Hole Peg Test (9HPT).
The outcome measure will be completion time (seconds).
Lower times indicate better hand dexterity.and
fine motor performance.
|
Baseline and Post-intervention (5 Weeks)
|
|
Manual Dexterity Measured by the Grooved Pegboard Test (GPT)
時間枠：Baseline and Post-intervention (5 Weeks)
|
Manual dexterity and sensorimotor coordination will be assessed using the Grooved Pegboard Test (GPT).
The outcome measure will be completion time (seconds).
Lower times indicate better manual dexterity and sensorimotor coordination.
|
Baseline and Post-intervention (5 Weeks)
|
|
Neuropathy-Related Quality of Life Measured by Neuropathy-Specific Quality of Life Questionnaire
時間枠：Baseline and Post-intervention (5 Weeks)
|
Neuropathy-related quality of life will be assessed using the Neuropathy-related Quality of Life Questionnaire.
The outcome measure will be the total questionnaire score (points) according to the instrument scoring manual.
|
Baseline and Post-intervention (5 Weeks)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SENS-UL-DPN-RCT-2026
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。