Digital Heath Integration With Neuromodulation Therapies on Diabetic Neuropathy

Digital Heath Integration With Neuromodulation Therapies on Sensory and Motor Function in Patients With Diabetic Neuropathy

This study will be carried out on 60 patients both gender male and female with diabetic neuropathy with age55-65 years. The patients will be selected from Elmahmoudia hospital .patients will be randomly assigned to two groups.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Neuropathies
• Intervention / Treatment: Device: experimental group; Device: control group

Detailed Description

Experimental Group:

This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment.

Control Group:

This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: marwa mahmoud, phd; Phone Number: 02 01156033818; Email: marwadd999@gmail.com
• Study Contact Backup: Name: alaa marzouk, master; Phone Number: 02 01001346787; Email: alaamarzouk136@gmail.com

Study Locations

• Egypt
  • Dokki, Egypt
    • Recruiting
    • Faculty of Physical Therapy
    • Contact: alaa marzouk, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Diagnosis of diabetes based on World Health Organization (WHO) with ages from 55to 65years 2. BMI> 25kg/m2 3. Clinically diagnosed with diabetic neuropathy. 4. All patients are taking oral hypoglycemic drugs with controlled diabetes mellitus.

  5. Willingness to comply with the study procedures and interventions. 6. Ability to provide informed consent. 7. presenting with Distal symmetric polyneuropathy (DSPN) based on a score of ≥7 on the validated Michigan Neuropathy Screening Instrument (MNSI) questionnaire.

  8. exhibiting moderately controlled blood pressure

Exclusion Criteria:

• 1. Presence of other significant neurological or musculoskeletal disorders that may confound the assessment of outcomes.

  2. Severe cognitive impairment or inability to provide informed consent. 3. Any recent surgical procedures or major medical events that could affect the study outcomes.

  4. Fracture. 5. Heart Failure. 6. Uncooperative patients. 7. Anemic patient. 8. Patients with liver diseases. 9. Smokers Patients. 10. Any cardiac pacemaker, automatic implantable cardioverter defibrillator (AICD), or other implanted electrical device 11. An existing deep vein thrombosis (DVT) 12. Any metal implants 13. Current foot ulceration or other lower limb skin ulcers 14. Any other cause of neuropathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment	Device: experimental group; This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment; Other Names: TENS and NMES
Placebo Comparator: control group; This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment	Device: control group; This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment; Other Names: placebo TENS and NMES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nerve conduction velocity	Adhesive patches called surface electrodes are placed on the skin over nerves or muscles at different spots. A very mild electrical impulse is applied via other patches or a handheld stimulator to stimulate the nerve. The resulting electrical activity of the nerve is recorded by the electrodes. The distance between electrodes and the time it takes for electrical impulses to travel between electrodes are used to measure the speed of the nerve signals. It is normal for several different nerves to be tested.	10 weeks
Electromyography	An EMG evaluates the electrical activity a muscle produces at rest and when it contracts, similar to an EKG of the heart muscle. The doctor places a single, small, Teflon-coated wire pin into selected muscles to be studied. The tip of the pin acts like an antenna, picking up electrical activity from the muscle that can be heard and seen on a screen. You will be asked to tighten (contract) the muscle. Electrical activity is recorded and can be heard as popping and clicking sounds when the muscle is contracting	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Google Fit	Google Fit is a mobile application developed by Google that focuses on tracking and monitoring physical activity and overall fitness. It is designed to help users lead healthier lifestyles by providing them with tools to set fitness goals, track their activity levels, and monitor their progress over time	10 weeks
Manage My Pain	Manage My Pain is a mobile application designed to assist individuals in tracking and managing chronic pain. It provides a comprehensive set of tools for users to monitor pain levels, treatments, and overall well-being. The app allows users to record detailed information about their pain, including intensity, location, triggers, and associated symptoms	10 weeks
PEDIS Score Diabetes App	PEDISScore is a mobile application developed for the assessment of diabetic neuropathy, a common complication of diabetes that affects the nerves. It is designed to assist healthcare professionals in evaluating the severity of diabetic neuropathy and monitoring its progression over time. The app utilizes the PEDISScore system	10 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: nesreen elnahas, phd, Professor

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2024
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Complications; Diabetic Neuropathies
• Other Study ID Numbers: P.T.REC/012/005260

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No