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Plantar Electrical Stimulation for Balance and Mobility in Diabetes and Hemodialysis

This study is testing a device called the Tennant Biomodulator® to see if it can improve balance and mobility in people with diabetes who are undergoing hemodialysis (a treatment for kidney failure). The device is placed on the feet and uses electrical stimulation. Researchers want to see if using this device for 12 weeks can improve how fast you walk, your overall balance, and other walking patterns. You may be able to join if you are over 40, have diabetes, are receiving dialysis, and can walk independently for 20 meters. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 100 participants. It will evaluate changes from the start of the study to 12 weeks later.
What's involved
Participants will have their gait speed, balance, and other walking parameters measured at the beginning of the study and again at 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after starting the intervention.

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NCT05407207

Therapeutic Plantar Electrical Stimulation Intervention During Hemodialysis to Improve Balance and Mobility

Recruiting
NAAges 40+InterventionalSupportive care
Hamad Medical Corporation
~100 participants
Updated 2022-06-07 on ClinicalTrials.gov
What's tested:Tennant Biomodulator ®

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in gait speed from baseline to 12 weeks
Measured over Baseline and12 weeks
+4 more outcomes measured

Conditions

Diabetes Mellitus
Hemodialysis Complication
Cardiovascular Complication
Quality of Life

Explore related trials

Complication of hemodialysisDiabetes Mellitus

Where it's being run

2 sites across 2 states
Texas1
Qatar1

Who to contact

Fadwa Al-Ali, MD
[email protected]
+974 55535066 · ext. +974 44394856
Email the study team

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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).

What this trial measures

  • Change in gait speed from baseline to 12 weeksBaseline and12 weeks

    The investigators will quantify gait speed (meter/sec) using a validated wearable device (LEGSys, Biosensics, MA, USA) during walking under both habitual and fast speed conditions.

  • Change in balance from baseline to 12 weeksBaseline and12 weeks

    Balance will be measured by assessing body sway area (cm\^2) from the center of mass during upright standing for a duration of up to 30 seconds. The investigators will use a validated wearable device (BALANSense, Biosensics, MA, USA) to measure body sway.

  • Change in gait parameters from baseline to 12 weeks.Baseline and 12 weeks

    Gait parameters such as gait initiation and gait inter-cycle variability will be assessed using a validated wearable device (LEGSys, Biosensics, MA, USA).

  • Change in skin perfusion from baseline to 12 weeks.Baseline and 12 weeks

    The investigators will assess skin perfusion by using an arterial Doppler. This will provide an ankle brachial index which will be used to categorize the level of ischemia/perfusion.

  • Change in fear of fallingBaseline and 12 weeks

    Changes in fear of falling will be assessed by a questionnaire (Short Falls Efficacy Scale International, FES-I). Score ranges from 16 to 64, with a higher score indicating increased concern for falling.