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

NCT ID: NCT06579716

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-07-01

Brief 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.

Detailed Description

Diabetes is a huge and rapidly growing health problem worldwide. In 2019, International Diabetes Federation ( IDF) estimated that the number of people with diabetes was 463 million and expected to be 578 million by 2030, and 700 million by 2045. Two-thirds of people with diabetes live in urban areas, and one in five people with diabetes is above 65 year.

Diabetic peripheral neuropathy is the most prevalent complication of diabetes mellitus. The prevalence of DPN ranges from 21.3 to 34.5% in type 2 DM (T2DM) and between seven to 34.2% in type 1 DM (T1DM).

The high incidence and prevalence of falls among older people with type 2 diabetes mellitus were identified as poor diabetic control, diabetic peripheral neuropathy (DPN) and balance impairment.

Study performed by Ahmed et al., reported that Kinesio tape and resistive exercise improve the dorsiflexors and functional performance in diabetic polyneuropathy.

A randomized controlled trial showed that WBV showed beneficial effects on pain, balance, and quality of life in patients with painful Diabetic peripheral neuropathy.

But till know no study reported us whole body vibration better than kineso or vice versa.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional balance exercise + Resistance exercise + Whole-body vibration

It consisted of 30 participants diagnosed as having diabetic peripheral neuropathy. Each received traditional balance exercise, resistance exercise, and whole-body vibration, for 6 weeks.

Group Type: EXPERIMENTAL

Traditional balance exercise

Intervention Type: OTHER

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 exercise

Intervention Type: OTHER

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)

Intervention Type: 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.

Traditional balance exercise + Resistance exercise + Kineso tape

It consisted of 30 participants diagnosed as having diabetic peripheral neuropathy. Each received traditional balance exercise, resistance exercise, and kineso tape, for 6 weeks.

Group Type: EXPERIMENTAL

Traditional balance exercise

Intervention Type: OTHER

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 exercise

Intervention Type: OTHER

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)}.

Kineso tape

Intervention Type: OTHER

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.

Interventions

Traditional balance exercise

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.

Intervention Type: OTHER

Resistance exercise

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)}.

Intervention Type: OTHER

Whole-body vibration (WBV)

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.

Intervention Type: OTHER

Kineso tape

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients type 2 diabetes with duration at least 10 years.
• Controlled blood glucose level examined via glycated hemoglobin exam (hba1cless than 9 and more than 6.5).
• Age of patient will range from 50 to 60 years.
• Patients had abnormal nerve conduction study.

Exclusion Criteria

• Patients having ulceration/infection of feet
• Medical/Surgical conditions limiting functional mobility
• Non-ambulatory patients
• Who are not willing to participate?
• Subjects with Type 1 Diabetes mellitus.
• Subjects with Gestational Diabetes.
• Subjects who are seriously ill.
• Lower limb fracture or trauma
• Significant renal hepatic disorder

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Lamis Samir Ahmed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hany Ezzat Obaya, PhD

Role: STUDY_CHAIR

Cairo University

Locations

Lamis Samir Ahmed

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/005322

Identifier Type: -

Identifier Source: org_study_id