Using electrical stimulation to improve balance and mobility in hemodialysis patients with diabetes
Official title: Therapeutic Plantar Electrical Stimulation Intervention During Hemodialysis to Improve Balance and Mobility
Run by Hamad Medical Corporation · NCT05407207 · Data updated 2026-11-12
This study is testing whether a wearable electrical device can help improve balance and mobility for people with diabetes who are on hemodialysis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hamad Medical Corporation Industry-sponsored |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2018 |
| Main results expected | October 20, 2022 |
| Study ends | November 11, 2022 |
| Registry record updated | June 7, 2022 |
| Trial ID | NCT05407207 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males and females over 40 years old with diabetes who are receiving dialysis and can walk independently.
✕Probably not a fit
Patients with active foot ulcers, major foot amputations, or significant psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to evaluate the effectiveness of a wearable electrical stimulator in enhancing balance, mobility, and quality of life for patients with diabetes undergoing hemodialysis. The intervention addresses the challenges of low physical activity and poor balance control, which are common among this population. By providing a convenient and innovative solution, the study seeks to improve peripheral blood flow and reduce the risk of foot complications. Participants will be monitored for their ability to engage in daily activities and overall health outcomes.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life and mobility for patients with diabetes undergoing hemodialysis.
How similar studies have gone: While exercise interventions have shown success in improving mobility in similar populations, the specific use of wearable electrical stimulation in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients with diabetes receiving dialysis who are \>40 years old. * Ambulatory (able to independently walk 20m with or without walking assistance). * Willing and able to provide informed consent. * Diabetes will be defined based on the American Diabetes Association (ADA) criteria (83). * Evidence of peripheral neuropathy and its severity will be determined based on a neurologic examination using criteria explained in the ADA statement. Exclusion Criteria: * Have an active foot ulcer, an active infection, Charcot neuroarthropathy, or major foot amputation. * Patients with any clinically significant medical or psychiatric condition, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study. * Patients concurrently participating in exercise training; major hearing/visual impairment; any patient with changes in psychotropic or sleep medications in the last 6 weeks. * If they were unlikely to fully comply with the follow-up protocol (e.g., travel plans).
Where it's running
-
Hamad Medical Corporation
Doha, Qatar Recruiting -
Baylor College of Medicine, USA
Houston, Texas, United States Active not recruiting
Study contacts
- Study coordinator: Fadwa Al-Ali, MD
- Email: falali1@hamad.qa
- Phone: +974 55535066
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.