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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorImam Abdulrahman Al Faisal Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Structured Multisensory Re-education Program

    Behavioral

    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.

  • Behavioral: Sham Sensory Exposure

    Behavioral

    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.

Treatment groups

59 Participants
are divided into 2 treatment groups
Group A: Multisensory Re-education GroupExperimental treatment 1 intervention
Group B: Sham Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite Sensory Function Score Measured Using Quantitative Sensory Testing (QST)

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.

Time frame
Baseline and Post-intervention (5 Weeks)

Secondary outcomes

1

Neuropathy Severity Measured by the Modified Total Neuropathy Score (mTNS)

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.

Time frame
Baseline and Post-intervention (5 Weeks)
2

Upper Limb Dexterity Measured by the Nine-Hole Peg Test (9HPT)

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.

Time frame
Baseline and Post-intervention (5 Weeks)
3

Manual Dexterity Measured by the Grooved Pegboard Test (GPT)

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.

Time frame
Baseline and Post-intervention (5 Weeks)
4

Neuropathy-Related Quality of Life Measured by Neuropathy-Specific Quality of Life Questionnaire

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.

Time frame
Baseline and Post-intervention (5 Weeks)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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