Actively Recruiting
Digital Health Integration With Neuromodulation Therapies on Sensory and Motor Function in Patients With Diabetic Neuropathy
Led by Cairo University · Updated on 2024-11-01
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of digital health combined with neuromodulation therapies on sensory and motor functions in patients with diabetic neuropathy. The study involves 60 male and female patients aged 55 to 65 years with type II diabetes and peripheral neuropathy. Participants are randomly assigned to two groups to assess the impact of these therapies alongside their medical treatment. One group of 30 patients will receive active transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES) for 30 minutes, three times a week, over 10 weeks, together with their standard medical care. The control group will receive placebo versions of these therapies following the same schedule and duration, also alongside medical treatment. During the study, participants will undergo several assessments including nerve conduction velocity and electromyography at 10 weeks. Additional monitoring involves digital tools such as the Google Fit app, Manage My Pain app, and the PEDIS Score Diabetes App to track symptoms and activity levels. The research team will monitor outcomes related to nerve function and patient-reported measures throughout the 10-week treatment period.
CONDITIONS
Brief Title
Digital Heath Integration With Neuromodulation Therapies on Diabetic Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of diabetes based on World Health Organization (WHO) criteria
- Age between 55 and 65 years
- Body mass index (BMI) greater than 25 kg/m2
- Clinically diagnosed diabetic neuropathy
- Taking oral hypoglycemic drugs with controlled diabetes mellitus
- Willingness to follow study procedures and interventions
- Ability to provide informed consent
- Presence of distal symmetric polyneuropathy with a Michigan Neuropathy Screening Instrument (MNSI) score of 7 or higher
- Moderately controlled blood pressure
You will not qualify if you...
- Other significant neurological or musculoskeletal disorders affecting outcomes
- Severe cognitive impairment or inability to consent
- Recent surgeries or major medical events
- Bone fractures
- Heart failure
- Uncooperative behavior
- Anemia
- Liver diseases
- Smoking
- Presence of cardiac pacemaker, implantable cardioverter defibrillator (AICD), or other implanted electrical devices
- Existing deep vein thrombosis (DVT)
- Metal implants
- Current foot or lower limb skin ulcers
- Any other cause of neuropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants will receive either active or placebo TENS and NMES device sessions for 30 minutes, 3 days per week, for 10 weeks along with their medical treatment.
3 visits per week for 10 weeks
Trial Site Locations
Total: 1 location
1
Faculty of Physical Therapy
Dokki, Egypt
Actively Recruiting
Research Team
A
alaa marzouk, master
M
marwa mahmoud, phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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