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NCT05407207 · ClinicalTrials.gov registry record · NA

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

A NA study of Diabetes Mellitus and Quality of Life, sponsored by Hamad Medical Corporation.

Recruiting
Registry status
NA
Development phase
100
Enrollment target
2
Study locations

NCT05407207: Recruiting NA study of Diabetes Mellitus and Quality of Life, sponsored by Hamad Medical Corporation.

NCT05407207 is a NA study of Diabetes Mellitus and Quality of Life that is actively recruiting participants, run by Hamad Medical Corporation. The registered enrollment target is 100 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05407207, a NA study of Diabetes Mellitus and Quality of Life, is actively recruiting participants, sponsored by Hamad Medical Corporation.

RECRUITING
Registry status
NA
Development phase
100 participants
Enrollment target
2
Study locations

Study 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, im

Primary Outcome

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.

Interventions

  • DEVICE Tennant Biomodulator ®

Study Locations (2)

Texas

  • Baylor College of Medicine, USA - Houston

Other

  • Hamad Medical Corporation - Doha

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2018-06-01
Est. Completion 2022-11-11
Phase NA
Hamad Medical Corporation

1 total trials

What NCT05407207 shows while recruiting

NCT05407207 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (95% lower).

The record links to 4 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Tennant Biomodulator ® is the first listed.

NCT05407207 reports a single indexed study location in Texas, Other.

Frequently Asked Questions

What is clinical trial NCT05407207 about?

NCT05407207 is a clinical study titled "Therapeutic Plantar Electrical Stimulation Intervention During Hemodialysis to Improve Balance and Mobility". 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...

What is the current status of trial NCT05407207?

This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2018-06-01. Estimated completion is 2022-11-11.

What conditions does trial NCT05407207 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Quality of Life, Hemodialysis Complication, Cardiovascular Complication.

What interventions are being tested in trial NCT05407207?

The interventions under investigation include: Tennant Biomodulator ® (DEVICE).

Who is sponsoring clinical trial NCT05407207?

This trial is sponsored by Hamad Medical Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05407207 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05407207's enrollment target sits among peer trials

100 118th of 208 higher than 86 of 208 other Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05407207, the US trial registry maintained by the National Library of Medicine. NCT05407207 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.