Digital Heath Integration With Neuromodulation Therapies on Diabetic Neuropathy

NCT ID: NCT06670430

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-10

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Diabetic Neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

experimental group

Intervention Type DEVICE

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

Group Type PLACEBO_COMPARATOR

control group

Intervention Type DEVICE

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

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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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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TENS and NMES placebo TENS and NMES

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Mohamed Abdelaty Marzouk

demonstrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nesreen elnahas, phd

Role: STUDY_CHAIR

professor

Locations

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Faculty of Physical Therapy

Dokki, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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alaa marzouk, master

Role: CONTACT

01001346787 ext. 02

marwa mahmoud, phd

Role: CONTACT

01156033818 ext. 02

Facility Contacts

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alaa marzouk, master

Role: primary

Other Identifiers

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P.T.REC/012/005260

Identifier Type: -

Identifier Source: org_study_id

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