Status:
RECRUITING
Therapeutic Plantar Electrical Stimulation Intervention During Hemodialysis to Improve Balance and Mobility
Lead Sponsor:
Hamad Medical Corporation
Collaborating Sponsors:
Qatar National Research Fund
Baylor College of Medicine
Conditions:
Diabetes Mellitus
Hemodialysis Complication
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
A high prevalence of diabetes has been reported in Qatar with nearly 23% population suffering from the pandemic, thereby increasing the associated healthcare cost. Low compliance with exercise and phy...
Detailed Description
This interdisciplinary project (Technology Readiness Level 9, TRL 9) aims to translate and clinically validate the effectiveness of an innovative wearable electrical stimulator technology for improvin...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 11 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05407207
Start Date
June 1 2018
End Date
November 11 2022
Last Update
June 7 2022
Active Locations (2)
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1
Baylor College of Medicine, USA
Houston, Texas, United States, 77030
2
Hamad Medical Corporation
Doha, Qatar, 3050