Not yet recruiting NCT07380191
EFFECT OF PLAZEPOD VERSUS ELECTRICAL STIMULATION ON RISK OF FALLING IN HEMODIALYSIS PATIENTS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Device + Behavioral, Neuromuscular Electrical Stimulation (NMES).
- Who it may be relevant to
- Registry conditions: Fall Risk, Fall Prevention. Basic parameters: 40 years — 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Device + 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 mi - Device Neuromuscular 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 administ
Primary outcome measures
- Risk of Falling Assessed by Timed Up and Go Test (TUG) [Time frame: Baseline and after 12 weeks of intervention]
- Balance Performance Assessed by Berg Balance Scale (BBS) [Time frame: Baseline and after 12 weeks]
- Lower Limb Muscle Strength [Time frame: Baseline and after 12 weeks]
Secondary outcome measures (2)
- Physical Activity Level [Time frame: Baseline and after 12 weeks]
- Kidney Disease-Related Quality of Life [Time frame: Baseline and after 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Tanta — Tanta
Identifiers
NCT: NCT07380191 · CairoU physical therapy