Diabetic Peripheral NeuropathySENS-ULNCT07670598
Efficacy of a Structured Multisensory Re-education Program on Sensory Function and Upper Limb Sensorimotor Performance in Individuals With Diabetic Peripheral Neuropathy.
A study testing Structured Multisensory Re-education Program in people with Diabetic Peripheral Neuropathy, run by Imam Abdulrahman Al Faisal Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Structured Multisensory Re-education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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:
- -
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Structured Multisensory Re-education Program, Behavioral: Sham Sensory Exposure
- Keywords
- Multisensory Rehabilitation, Sensorimotor Function, Upper Limb Function, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Multisensory Re-education ProgramBehavioural
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 ExposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavioral: Sham Sensory Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Post-intervention (5 Weeks)
Secondary outcomes (4)
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.
Measured: Baseline and Post-intervention (5 Weeks)
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.
Measured: Baseline and Post-intervention (5 Weeks)
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.
Measured: Baseline and Post-intervention (5 Weeks)
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.
Measured: Baseline and Post-intervention (5 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Al Faisal Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Turki Abualait, Imam Abdulrahman Al Faisal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670598
- Sponsor's protocol ID
- SENS-UL-DPN-RCT-2026
- Acronym
- SENS-UL
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07670598
- Acronym / sponsor ID
- SENS-UL / SENS-UL-DPN-RCT-2026
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Multisensory Rehabilitation, Sensorimotor Function, Upper Limb Function, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Al Faisal HospitalOther government
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multisensory Re-education Group | Experimental | Behavioral: Structured Multisensory Re-education ProgramParticipants 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. |
| Sham Control Group | Sham comparator | Behavioral: Behavioral: Sham Sensory ExposureParticipants will receive sham sensory exposure sessions without active sensory retraining. The frequency and duration of sessions will match the experimental group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Multisensory Re-education ProgramA 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. | Behavioural | Multisensory Re-education Group |
| Behavioral: Sham Sensory ExposureParticipants 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. | Behavioural | Sham Control Group |
Primary outcome
Composite Sensory Function Score Measured Using Quantitative Sensory Testing (QST)
Time frame: 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.
4 secondary outcomes
Neuropathy Severity Measured by the Modified Total Neuropathy Score (mTNS)
Time frame: Baseline and Post-intervention (5 Weeks)
Upper Limb Dexterity Measured by the Nine-Hole Peg Test (9HPT)
Time frame: Baseline and Post-intervention (5 Weeks)
Manual Dexterity Measured by the Grooved Pegboard Test (GPT)
Time frame: Baseline and Post-intervention (5 Weeks)
Neuropathy-Related Quality of Life Measured by Neuropathy-Specific Quality of Life Questionnaire
Time frame: Baseline and Post-intervention (5 Weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Multisensory Re-education Program in people with Diabetic Peripheral Neuropathy, run by Imam Abdulrahman Al Faisal Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Sensory Function Score Measured Using Quantitative Sensory Testing (QST) (time frame: Baseline and Post-intervention (5 Weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.