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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-50
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Severe neurological or orthopedic disorders affecting mobility.

Unstable cardiovascular conditions.

Cognitive impairment or sensory deficits.

Contraindications to neuromuscular electrical stimulation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: BlazePod Training plus Lifestyle EducationExperimental treatment 1 intervention
Group B: Tens plus Lifestyle EducationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Baseline and after 12 weeks of intervention
2

Balance Performance Assessed by Berg Balance Scale (BBS)

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.

Time frame
Baseline and after 12 weeks
3

Lower Limb Muscle Strength

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

Time frame
Baseline and after 12 weeks

Secondary outcomes

1

Physical Activity Level

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

Time frame
Baseline and after 12 weeks
2

Kidney Disease-Related Quality of Life

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

Time frame
Baseline and after 12 weeks

Other outcomes

1

Adherence to Intervention Program

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

Time frame
Throughout the 12-week intervention period

Sponsors and contacts

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