Whole-Body Vibration Versus Kineso Tape on Nerve Conduction in Patient With Diabetic Peripheral Neuropathy
NCT Number: NCT06579716
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Peripheral Neuropathy
Interventions: OTHER: Traditional balance exercise|OTHER: Resistance exercise|OTHER: Whole-body vibration (WBV)|OTHER: Kineso tape
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-01
Completion Date: 2024-07-01
Locations: Lamis Samir Ahmed, Cairo, Egypt

Summary:
The purpose of the study was to compare between effect of whole-body vibration and kineso tape on nerve conduction in patients with diabetic peripheral neuropathy.

Primary Outcome Measures: Deep peroneal nerve motor conduction velocity, It was measured for all participants in both groups before and after treatment, using Neuropack S1 MEB-9004 NIHON KODEN, JAPAN nerve conduction velocity device., 6 weeks|Sural nerve sensory conduction velocity, It was measured for all participants in both groups before and after treatment, using Neuropack S1 MEB-9004 NIHON KODEN, JAPAN nerve conduction velocity device., 6 weeks|Berg Balance Scale, It was used to measure the balance for all participants in both groups before and after treatment. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. The scale takes approximately 10 to 20 minutes to complete requiring minimal equipment (chair, stopwatch, ruler, and step) and minimal space Berg balance have high validity and reliability. Interpretation: 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk., 6 weeks|Unilateral Stance Test (UST), It was used to assess postural balance for all participants in both groups before and after treatment. Each subject was instructed to maintain balance on the nondominant leg with eyes opened, eyes closed, and arms spread for as long as possible. The time taken for the contralateral foot to touch the ground was measured in seconds using a stopwatch. This test was performed twice, and the highest score was recorded., 6 weeks|Smartphone Kinesis Balance™ fall prevention app, It was used to assess balance and falls risk for all participants in both groups before and after treatment. The app is freely available on the Google Play store, with participants consenting to use of their anonymized data for research and product improvement. The app uses a questionnaire on clinical falls risk factors, combined with a standing balance test and machine learning algorithms to assess balance and falls risk. Participants are provided with advice and exercises to stay healthy and help prevent falls, based on their level of risk (as determined by the smartphone based machine learning algorithm). All data were anonymized at source and transmitted via encrypted channel to a web server where they were stored (in line with GDPR and HIPAA data privacy regulations) for subsequent offline analysis. Data were extracted from the database using MySQL workbench 8.0 (Oracle, CA, USA) and analyzed using Matlab v 9.3.0 (Mathworks, Natick, VA, USA)., 6 weeks|Quadriceps femoris muscle strength, It was assessed for all participants in both groups before and after treatment, using hand held dynamometry. To evaluate quadriceps muscle strength, the patients were positioned in the prone position, lying with the knee flexed to 90 degrees; the dynamometer was fixed proximal to the ankle on the anterior surface of the leg; and the subjects were asked to perform isometric knee extension. Three maximal isometric contractions were recorded, and the average of the three trials was used for analysis., 6 weeks|Tibialis anterior muscle strength, It was assessed for all participants in both groups before and after treatment, using hand held dynamometry. To evaluate tibialis anterior strength, patients were asked to lie supine with their ankles at the edge of the plinth. The ankle joints were placed in the neutral position (between dorsiflexion and plantar flexion). The dynamometer was fixed to the dorsal aspect of the foot, and each subject was asked to perform isometric dorsiflexion. Three maximal isometric contractions were recorded, and the average of the three trials was used for analysis., 6 weeks