Clinical trial NCT06579716: Whole-Body Vibration Versus Kineso Tape on Nerve Conduction in Patient With Diabetic Peripheral Neuropathy
Official title: Whole-Body Vibration Versus Kineso Tape on Nerve Conduction in Patient With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Deep peroneal nerve motor conduction velocity
timeFrame: 6 weeks
measure: Sural nerve sensory conduction velocity
timeFrame: 6 weeks
measure: Berg Balance Scale
timeFrame: 6 weeks
measure: Unilateral Stance Test (UST)
timeFrame: 6 weeks
measure: Smartphone Kinesis Balance™ fall prevention app
timeFrame: 6 weeks
measure: Quadriceps femoris muscle strength
timeFrame: 6 weeks
measure: Tibialis anterior muscle strength
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Lamis Samir Ahmed
Study officials:
affiliation: Cairo University
name: Hany Ezzat Obaya, PhD
role: STUDY_CHAIR
References: