tSCS and AR on Pain and Balance in Diabetic Peripheral Neuropathy
ConditionDiabetic Neuropathies
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRiphah International University
About this trial
tSCS and AR-based training have individually shown benefits in neuromotor rehabilitation; no study to date has evaluated their combined effects on pain, balance, lower-limb strength, retention, and vibration sense in diabetic neuropathy. The rationale for combining them lies in their complementary mechanisms: tSCS at 30 Hz activates large-diameter Aβ afferents, inhibiting nociceptive input, enhancing spinal excitability, and facilitating motor activation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
More than or equals to 4 score on Douleur Neuropathique 4 Questionnaire
More than or equals to 6 Hz at Neurothesiometer
More than or equals to 4 score on the Numeric Pain Rating Scale (NPRS)
Disqualifiers
Cognitively compromised (MOCA ≤ 26/30)
Metallic implants at skull
Shunting
Skin allergy
Trial design
Design model
Parallel
Treatments tested in this trial
transcutaneous spinal cord stimulation
Other interventionTranscutaneous spinal cord stimulation will be administered non-invasively using surface electrodes placed over the D12-L1 spinal segment. This segmental level has been shown to effectively engage lower-limb motor and sensory networks across multiple spinal segments. Stimulation will be delivered using the Soterix 1×1 Transcutaneous Electrical Stimulation (TES) unit. Stimulation will be applied at a frequency range of 30 Hz. Pulse duration of 1 ms, and intensity will be set at 2 mA. A ramp-up and ramp-down time of 30 seconds will be used to enhance participant comfort during the start and end of each stimulation session, following standardized electrode placement and safety protocols.
Augmented Reality
Other interventionAR-based rehabilitation will consist of interactive balance and coordination tasks conducted in a virtual environment, with real-time visual feedback provided to guide movement accuracy and postural control. The core training block will include five structured modules: interactive kicking exercises to promote ankle and knee coordination; color-target foot-reaching tasks to enhance proprioception and reaction time; virtual obstacle navigation to improve gait and stepping control; static and dynamic balance challenges, such as maintaining posture on virtual planks; and lower-limb strengthening activities, including squats and stepping-based games. Each module will be performed for 5-8 minutes, with brief rest periods between tasks.
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Transcutaneous spinal cord stimulation and Augmented Reality GroupExperimental treatment 2 interventions
Group B: Augmented Reality GroupActive comparator 1 intervention
Group C: Transcutaneous spinal cord stimulation GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is a quick, 11-point measure (0 = no pain to 10 = worst imaginable) commonly used across clinical and research settings. Recent studies demonstrate test-retest reliability ranging from 0.58 to 0.93 (good to excellent), with moderate evidence for a minimal clinically important difference (MCID) of 1.5-2.5 points.
Time frame
Up to week 5 (baseline/week 1/week 5)2
Time Up and Go (TUG)
The TUG test is a simple, clinically validated tool used to assess dynamic balance and functional mobility. It requires an individual to rise from a seated position, walk three meters, turn, return, and sit down. The TUG demonstrated excellent test-retest reliability, with intraclass correlation coefficients (ICC) ranging from 0.89 to 0.94 across multiple trials.
Time frame
Up to week 5 (Baseline/week 1/week 5)Secondary outcomes
1
30 Second Chair Stand Test
The 30-Second Chair Stand Test is a widely used, performance-based tool for assessing lower-limb strength and functional mobility. Among individuals with type 2 diabetes mellitus, a population commonly affected by diabetic neuropathy, the test has demonstrated excellent reliability. A test-retest intraclass correlation coefficient (ICC) of 0.92, indicating excellent relative reliability. In terms of measurement precision, the standard error of measurement (SEM) was 1.08 repetitions, and the smallest real difference (SRD) was 3 repetitions, reflecting the threshold for clinically meaningful change.
Time frame
Up to week 5 (Baseline/week 1/week 5)2
Neurothesiometer
The neurothesiometer is a non-invasive and reliable instrument used to assess vibration perception threshold (VPT). It has demonstrated excellent reliability, with intra-class correlation coefficients (ICCs) exceeding 0.90, indicating strong measurement consistency. A VPT cut-off value of ≥ 6 Hz is indicative of neuropathy. Owing to its ease of use, objective quantification, and ability to detect subclinical neuropathy, the neurothesiometer is highly valuable in clinical practice. Its superior standardization makes it a preferred method for evaluating protective sensation and vibration loss, particularly in individuals with diabetes.
Time frame
Up to week 5 (Baseline/Week 1/week 5)Sponsors and contacts
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Source ClinicalTrials.gov
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