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

NCT07670598 | Not Yet Recruiting

• 1 other identifier: SENS-UL-DPN-RCT-2026
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Multisensory Rehabilitation; Sensorimotor Function; Upper Limb Function; Quality of Life

Outcome Measures

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.

  Baseline and Post-intervention (5 Weeks)

Secondary Outcomes (4)

• 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)

Study Arms (2)

Multisensory Re-education Group

EXPERIMENTAL

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.

Behavioral: Structured Multisensory Re-education Program

Sham Control Group

SHAM COMPARATOR

Participants will receive sham sensory exposure sessions without active sensory retraining. The frequency and duration of sessions will match the experimental group.

Behavioral: Behavioral: Sham Sensory Exposure

Interventions

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.

Multisensory Re-education Group

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.

Sham Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Imam Abdulrahman Al Faisal Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Physical Therapy, Imam Abdulrahman Bin Faisal University

Model Details: Participants will be randomly assigned to either a structured multisensory re-education intervention group or a sham-control group using a parallel-group design. Outcomes will be assessed at baseline and after completion of the intervention.

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06