Whole-Body Vibration Versus Kineso Tape on Nerve Conduction in Patient With Diabetic Peripheral Neuropathy

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 50 to 60 years
• All sexes
• No healthy volunteers
• Adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Diabetic Peripheral Neuropathy

Being tested

Traditional balance exercise, Resistance exercise, Whole-body vibration (WBV), Kineso tape

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Traditional balance exerciseOther

  All patients in both group received a traditional balance exercise program, 3 sessions per week, for 6 weeks. Each session of exercise comprised 10 min of warm-up, 40min of balance exercise, and 5min of cool down. Warm-up included treadmill walking. Balance exercise comprised two sets of sit to stand, one leg stance, tandem stance and 30 squats. The first set of exercises was performed on a stable surface, whereas the second set of exercises was performed on an unstable surface by using Thera band stability trainer. Each set of each exercise was performed for 3 min, with 1-2 min of rest in between the exercises. Cool-down included deep breathing, abdominal breathing, and mild stretching.

• Resistance exerciseOther

  All patients in both group received a resistance exercise program, 3 sessions per week, for 6 weeks. Each patient was seated in sitting position and the weight sandbags was applied at the dorsum of the foot. The resistance was set to be around 40%-60% of the 1RM. The patient performed the exercise for 3 bouts, every bout 10 repetitions. The one repetition maximum (1RM) was established prior to the training period using the following equation: 1 RM = Weight (kg) X (1 + {0.033 X number of repetitions)}.

• Whole-body vibration (WBV)Other

  Patients were asked to stand barefoot on the vibratory platform with an even distribution of weight on both feet and familiarized with WBV at a lesser frequency and amplitude. Then, they were asked to bend their knee 30º to the vertical; thereafter, to obtain a greater muscular response, WBV training was performed at a frequency of 30 Hz and an amplitude of 2mm. The exercise comprised five bouts of a 30-sec vibration with a 1-min elapse between the bouts.

• Kineso tapeOther

  Kineso tape was applied to dorsiflexors 24 hours a day and was replaced every 5 days for patients who were taped in accordance with Kenzo Kase's Kinesio taping Manual. For taping, each patient's leg was placed in a relaxed position while he sat on a taping table. The skin was to be free of oils and lotions, to avoid anything that might limit the acrylic adhesive's ability to adhere to the skin. So, the subject's skin was cleaned with alcohol prior to tape application. For the Tibialis anterior, tape was measured from the muscle origin to the insertion while the muscle was stretched. The base of the tape was applied to the origin at the lateral condyle and superior 2/3 of anterolateral surface of tibia. Then the subject was asked to stretch the foot into plantar flexion and eversion; taping was then finished toward the insertion at the medial and plantar surface of medial cuneiform and base of the first metatarsal.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: 6 weeks

2. 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.

   Measured: 6 weeks

3. 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.

   Measured: 6 weeks

4. 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.

   Measured: 6 weeks

5. 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).

   Measured: 6 weeks

6. 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.

   Measured: 6 weeks

7. 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.

   Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted30 Aug 2024
2. Study start1 Nov 2022
3. Primary completion1 Jun 2024
4. Study completion1 Jul 2024

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.
• More trials run by Cairo UniversityThe sponsor's other registered studies.
• 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.