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NCT Number: NCT07380191

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

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

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Key information

Age range

40 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tanta

Tanta, Alquarbia, 31111, Egypt

Location contact

Heba Ali ABDELGHAFAR ALI, Phd

SUB_INVESTIGATOR

Sally Hafez Mohamed el said, Phd

CONTACT

[email protected]

0100101111315 ext. 0100101111315

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Device + Behavioral

Device

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.

Neuromuscular Electrical Stimulation (NMES)

Device

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.

Primary outcomes

  1. Risk of Falling Assessed by Timed Up and Go Test (TUG)

    Time frame: Baseline and after 12 weeks of intervention

    Change 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.

  2. Balance Performance Assessed by Berg Balance Scale (BBS)

    Time frame: Baseline and after 12 weeks

    Change 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.

  3. Lower Limb Muscle Strength

    Time frame: Baseline and after 12 weeks

    Change in lower limb muscle strength measured using a hand-held dynamometer, recorded in kilograms (kg).

Secondary outcomes

  1. Physical Activity Level

    Time frame: Baseline and after 12 weeks

    Change in physical activity level measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), expressed in MET-minutes/week.

  2. Kidney Disease-Related Quality of Life

    Time frame: Baseline and after 12 weeks

    Change in quality of life measured using the Kidney Disease Quality of Life Short Form questionnaire (KDQOL-36), reported as total score.

Other outcomes

  1. Adherence to Intervention Program

    Time frame: Throughout the 12-week intervention period

    Participant adherence to the prescribed physical intervention and lifestyle education sessions, expressed as percentage of attended sessions.

Study contacts

Contact information is provided by the study sponsor or research team.

Samia Wagdy El said Diab, PHD

CONTACT

[email protected]

01094762028 ext. 01094762028

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: HD Fall Risk

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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