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Recruiting NCT06670430

Digital Heath Integration With Neuromodulation Therapies on Diabetic Neuropathy

No phase Interventional Diabetic Neuropathies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: experimental group, control group.
Who it may be relevant to
Registry conditions: Diabetic Neuropathies. Basic parameters: 55 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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
  • 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

Primary outcome measures

  • nerve conduction velocity [Time frame: 10 weeks]
  • Electromyography [Time frame: 10 weeks]
Secondary outcome measures (3)
  • Google Fit [Time frame: 10 weeks]
  • Manage My Pain [Time frame: 10 weeks]
  • PEDIS Score Diabetes App [Time frame: 10 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Physical Therapy — Dokki

Identifiers

NCT: NCT06670430 · P.T.REC/012/005260

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗