Development, Validation and Feasibility Testing of a Proprioception and Vibration Sense Therapeutic Device in Patients with Diabetic Peripheral Neuropathy

Diabetes is a common non-communicable disease which became a global health crisis, with the prevalence projected to reach 629 million by 2045. This surge, is particularly in lower-middle-income countries like India. This study aims to address the critical gap in DPN management by developing, validating, and assessing the feasibility of a novel, portable, and user-friendly therapeutic device. This device will facilitate early and cost-effective diagnosis of proprioceptive and vibration sense deficits and provide targeted training to improve these modalities in DPN patients. The study will be conducted in three phases: 1) Development Phase: Focuses on creating a device that incorporates vibration perception threshold evaluation and a proprioception training mechanism. 2) Validation Phase: Will determine the construct and concurrent validity of the developed device for evaluating proprioception and vibration perception threshold. 3) Pilot Trial: A pilot study will be conducted to assess the effects of vibration sense and proprioceptive training among DPN patients using the developed device. In Phase II, concurrent validity will be assessed by correlating device-derived proprioception and vibration perception scores with biothesiometer values and proprioception scores using the Pedalo-Sensamove Balance Test Pro, employing Pearson’s or Spearman’s correlation, and interpreting the results based on standard thresholds. Phase III will evaluate pre- and post-intervention changes using a parametric or a nonparametric test.