Efficacy of a Structured Multisensory Re-education Program on Sensory Function and Upper Limb Sen… (NCT07670598) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of a Structured Multisensory Re-education Program on Sensory Function and Upper Limb Sensorimotor Performance in Individuals With Diabetic Peripheral Neuropathy.
59 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite Sensory Function Score Measured Using Quantitative Sensory Testing (QST)
Timeframe: Baseline and Post-intervention (5 Weeks)