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

NCT07380191 | Not Yet Recruiting DMC

• 1 other identifier: CairoU physical therapy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fall Risk, Fall Prevention

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and after 12 weeks of intervention

• 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.

  Baseline and after 12 weeks

• Lower Limb Muscle Strength

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

  Baseline and after 12 weeks

Secondary Outcomes (2)

• Physical Activity Level

  Baseline and after 12 weeks

• Kidney Disease-Related Quality of Life

  Baseline and after 12 weeks

Other Outcomes (1)

• Adherence to Intervention Program

  Throughout the 12-week intervention period

Study Arms (2)

BlazePod Training plus Lifestyle Education

EXPERIMENTAL

Participants in this arm will receive an interactive sensorimotor training program using the BlazePod system combined with a structured lifestyle education program. BlazePod training will focus on improving balance, reaction time, coordination, and functional mobility through static and dynamic balance tasks, reactive stepping, and lower-limb coordination exercises. Training sessions will be conducted three times per week for 30 minutes over a period of 12 weeks under the supervision of a physical therapist. In addition, participants will attend a weekly lifestyle education session addressing renal nutrition, fluid management, safe physical activity, fall prevention strategies, sleep hygiene, fatigue management, and medication adherence.

Device: Neuromuscular Electrical Stimulation (NMES)

Tens plus Lifestyle Education

ACTIVE COMPARATOR

Participants in this arm will receive neuromuscular electrical stimulation (NMES) applied to the lower limb muscles, including bilateral quadriceps and hamstrings, combined with the same structured lifestyle education program as the experimental group. NMES will be delivered using a portable electrical stimulation device with parameters adjusted to produce visible and comfortable muscle contractions. Sessions will be conducted three times per week for 30 minutes over 12 weeks under physical therapist supervision. Lifestyle education sessions will be provided once weekly and will include renal nutrition, fluid control, safe physical activity, fall prevention strategies, sleep hygiene, fatigue management, and medication adherence.

Device: Device + Behavioral; Device: Neuromuscular Electrical Stimulation (NMES)

Interventions

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.

Tens plus Lifestyle Education

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.

BlazePod Training plus Lifestyle Education; Tens plus Lifestyle Education

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Tanta

Tanta, Alquarbia, 31111, Egypt

Location

Related Links

• This website provides scientific articles and studies related to lifestyle interventions, physical exercise, and fall risk in hemodialysis patients.

Central Study Contacts

Samia Wagdy El said Diab, PHD

CONTACT

01094762028; Samiaahmeddiab@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EFFECT OF PLAZEPOD VERSUS ELECTRICAL STIMULATION ON RISK OF FALLING IN HEMODIALYSIS PATIENTS

Model Details: 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

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 2, 2026
• Study Start: March 21, 2026
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): March 22, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

EG (1)