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EFFECT OF PLAZEPOD VERSUS ELECTRICAL STIMULATION ON RISK OF FALLING IN HEMODIALYSIS PATIENTS

EFFECT OF PLAZEPOD VERSUS ELECTRICAL STIMULATION ON RISK OF FALLING IN HEMODIALYSIS PATIENTS

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07380191
Acronym
HD Fall Risk
Enrollment
60
Registered
2026-02-02
Start date
2026-03-21
Completion date
2027-03-22
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall Risk, Fall Prevention

Brief summary

Renal nutrition Fluid control Safe physical activity Sleep hygiene, energy and managing fatigue Adherence and awareness

Detailed description

Application of PlazePod Device and Electrical Stimulation and comparison between them to decrease fall Risk in Hemodialysis Patients

Interventions

DEVICEDevice + Behavioral

This intervention consists of interactive sensorimotor training using the BlazePod system, a visual stimulus-based device designed to improve balance, coordination, reaction time, and functional mobility. Participants will perform static and dynamic balance exercises, reactive stepping drills, lower-limb coordination tasks, and dual-task activities in response to visual cues emitted by the BlazePod sensors. Training sessions will be conducted three times per week, with each session lasting 30 minutes, over a total duration of 12 weeks. All sessions will be supervised by a licensed physical therapist to ensure safety and appropriate progression of exercise difficulty. The intervention aims to reduce fall risk by enhancing neuromuscular control and postural stability in hemodialysis patients.

DEVICENeuromuscular Electrical Stimulation (NMES)

This intervention involves the application of neuromuscular electrical stimulation to the lower limb muscles, specifically the bilateral quadriceps and hamstrings, using a portable electrical stimulation device. Surface electrodes will be placed over the motor points to elicit visible and comfortable muscle contractions. Stimulation parameters will include a frequency of 35-50 Hz, pulse width of 200-400 microseconds, and a duty cycle of 10 seconds on and 30 seconds off. Sessions will be administered three times per week for 30 minutes over 12 weeks under the supervision of a physical therapist. The intervention aims to improve muscle strength, balance, functional mobility, and reduce fall risk in hemodialysis patients.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Application of PlazePod Device and Electrical Stimulation for 60 patients each group 30 for 3months for 40-50age Additionally life style education program, such as: Renal nutrition Fluid control Safe physical activity Sleep hygiene, energy and managing fatigue Adherence and awareness For 3 months, there was one session every week, lasting 30 minutes

Intervention model description

Application two Devices of PlazePod Device and Electrical Stimulation for 60 patients each group 30 for 3months for 40-50age Additionally life style education program, such as: Renal nutrition Fluid control Safe physical activity Sleep hygiene, energy and managing fatigue Adherence and awareness For 3 months, there was one session every week, lasting 30 minutes and comparison between two groups

Eligibility

Sex/Gender
MALE
Age
40 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* : * Male patients aged 40 to 50 years. * Diagnosed with end-stage renal disease and receiving maintenance hemodialysis for at least 6 months. * Medically stable and cleared by a nephrologist to participate in physical activity and/or electrical stimulation. * Able to ambulate independently or with minimal assistance. * Cognitively able to understand study procedures. * Not participating in any other structured exercise program.

Exclusion criteria

* Severe neurological or orthopedic disorders affecting mobility. * Unstable cardiovascular conditions. * Cognitive impairment or sensory deficits. * Contraindications to neuromuscular electrical stimulation.

Design outcomes

Primary

MeasureTime frameDescription
Risk of Falling Assessed by Timed Up and Go Test (TUG)Baseline and after 12 weeks of interventionChange in risk of falling measured using the Timed Up and Go (TUG) test, recorded in seconds. Lower scores indicate better functional mobility and reduced fall risk.
Balance Performance Assessed by Berg Balance Scale (BBS)Baseline and after 12 weeksChange in static and dynamic balance measured using the Berg Balance Scale (BBS), scored from 0 to 56 points, with higher scores indicating better balance performance.
Lower Limb Muscle StrengthBaseline and after 12 weeksChange in lower limb muscle strength measured using a hand-held dynamometer, recorded in kilograms (kg).

Secondary

MeasureTime frameDescription
Physical Activity LevelBaseline and after 12 weeksChange in physical activity level measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), expressed in MET-minutes/week.
Kidney Disease-Related Quality of LifeBaseline and after 12 weeksChange in quality of life measured using the Kidney Disease Quality of Life Short Form questionnaire (KDQOL-36), reported as total score.

Countries

Egypt

Contacts

CONTACTSamia Wagdy El said Diab, PHD
Samiaahmeddiab@gmail.com01094762028

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026