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

NCT05407207 | Recruiting DMC FDA Device

• 1 other identifier: NPRP 10-0208-170400
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

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 physical activity in patients with diabetes increases foot risk complications, deteriorates health, and further increases economic costs. This is particularly true among patients with diabetes who are undergoing hemodialysis (HD) process. Exercise interventions have been shown to improve mobility and balance, reduce the incidence of falls, and improve peripheral blood flow, which is essential to reduce foot problems and peripheral arterial disease. However, uptake of exercise programs for individuals who are undergoing HD treatment has been limited. The three main factors limiting uptake and adherence among HD patients are time availability, post-dialysis fatigue, and transportation to exercise programs, which are usually offered in rehabilitation departments or cardiovascular centers but not in nephrology departments or in free-standing dialysis clinics. Many of these patients visit clinics 3 times a week to receive hemodialysis, providing an optimal opportunity for intervention. Thus the investigators are proposing an innovative intervention based on plantar electrical stimulation treatment during HD (3 times per week) to enhance balance and quality of life while reducing the risk of peripheral arterial diseases and diabetic foot ulcers, which are highly prevalent among people with diabetes and chronic kidney disease. This interdisciplinary study is based on preliminary studies, in which the investigators demonstrated that regular plantar electrical stimulation is an effective and practical therapy to enhance motor performance and plantar sensation in patients with diabetes. The scientific premise of the proposed intervention has been also supported by literature as well as three systematic reviews suggesting the effectiveness of electrical stimulation to reduce pain, improve balance, improve skin perfusion, and improve plantar sensation. In the context of this study, the investigators propose to bring an innovative technology based on an FDA-cleared bio-electric stimulation technology (BEST®) microcurrent platform, named Tennant Biomodulator® (Avazzia Inc., Dallas, TX, USA), which is a transcutaneous electrical nerve stimulator (TENS) and has been designed for symptomatic relief and management of chronic pain. However, the system was modified to provide electrical stimulation to the plantar area via two electrodes placed on the hind and forefoot area instead of the leg. The device has a 60-minute run cycle after which it automatically turns off. In the context of a previous study funded by QNRF, the investigators developed and tested 50 electrical stimulation units (which will be used in the context of the study), including 25 active systems and 25 placebo systems. The placebo systems are similar to active systems in the appearance and functioning of lights and indicators. However, they were programmed not to provide any electrical current. In a preliminary study, the proof of concept of this revised technology was tested in the context of enhancing balance and skin perfusion in ambulatory patients with diabetes and peripheral neuropathy. In the context of this study, the investigators plan to translate this technology for routine treatment during HD sessions for patients with diabetes who are undergoing regular HD treatment. Using a double-blinded randomized-controlled model, the investigators will validate the effectiveness of this technology to enhance balance, reduce pain, and improve skin perfusion. One hundred (n=100) HD volunteers with diabetes will be recruited and randomized to either intervention (n=50) or control (CG: n=50) group for the purpose of this study. Plantar electrical stimulation will be provided during HD sessions, 3 times per week and for 12 weeks. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks to examine the effectiveness of the proposed intervention to enhance balance, improve quality of life, and improve lower extremity skin perfusion among HD patients with diabetes. This proposal is in line with Qatar National Priorities Research goals and if successful the result will open new doors to managing diabetes and kidney failure. In a setting where no therapeutic agents or interventions effectively address poor balance and loss of protective sensation among HD patients with diabetes and where affected individuals life with a heightened risk of developing a debilitating foot ulcer and quite possibly a disabling amputation, the potential impact from the plantar electrical stimulation system may offer the potential for significant clinical benefit, with very low risk, and with ease of implementation in routine care application for patients who are undergoing HD treatment.

Conditions

Diabetes Mellitus; Hemodialysis Complication; Cardiovascular Complication; Quality of Life

Keywords

Preventive supplements; Treatment of diabetes related complications; Health intervention; Lifestyle intervention

Outcome Measures

Primary Outcomes (5)

• Change in gait speed from baseline to 12 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.

  Baseline and12 weeks

• Change in balance from baseline to 12 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.

  Baseline and12 weeks

• Change in gait parameters from baseline to 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).

  Baseline and 12 weeks

• Change in skin perfusion from baseline to 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.

  Baseline and 12 weeks

• Change in fear of falling

  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.

  Baseline and 12 weeks

Secondary Outcomes (4)

• Change in quality of life from baseline to 12 weeks.

  Baseline and 12 weeks

• Change in cognitive function

  Baseline and 12 weeks

• Change in pain

  Baseline to 12 weeks

• Change in depression

  Baseline to 12 weeks

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The intervention group will take part in a 12-week plantar electrical stimulation intervention using the proposed technology 3 times per week during HD either in a sitting or supine position under the supervision of a research staff member. The duration of each treatment session will be one hour. Patients who receive an activated electrical stimulation unit will receive a standard dose of 30 milliamps as described in the following during each HD session (3 times per week for 12 weeks).

Device: Tennant Biomodulator ®

Control group

SHAM COMPARATOR

Placebo controls will have an electrical stimulation unit programmed not to provide any electrical current, while all other lights and programming indicators will be functional. Both active and inactive electrical stimulation units will be programmed to download the period that they are used on a weekly basis in order to verify that the units are used for the prescribed time period.

Device: Tennant Biomodulator ®

Interventions

Tennant Biomodulator ® DEVICE

Tennant Biomodulator ® (Avazzia, Inc., Texas, USA)(FDA Classification: 882.5890 Neurology, Biofeedback device) is FDA-cleared for symptomatic relief and management of chronic pain. The device is simply activated using device buttons and does not need to be adjusted or monitored once therapy begins, making it easy for the purpose of therapy under unsupervised conditions or for use in busy HD clinics. The device will be used with FDA-cleared TENS electrodes that will be connected to the device via wires, providing an electrically conductive interface between the device and the subject's skin.

Also known as: AVAZZIA

Control group; Intervention group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Qatar National Research Fund: collaborator
• Baylor College of Medicine: collaborator

Study Sites (2)

Baylor College of Medicine, USA

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

Hamad Medical Corporation

Doha, 3050, Qatar

RECRUITING

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MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Fadwa Al-Ali, MD

CONTACT

+974 55535066; falali1@hamad.qa

Abdullah Hamad, MD

CONTACT

+974 33486848; ahamad9@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The patients and the clinical coordinator who will evaluate and monitor study patients will both be blinded to the type of electrical stimulation unit (active v. sham).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective cohort study with a double-blinded randomized control trial model.

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: June 7, 2022
• Study Start: June 1, 2018
• Primary Completion: October 20, 2022
• Study Completion: November 11, 2022
• Last Updated: June 7, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

QA (1); US (1)