EFFECT OF PLAZEPOD VERSUS ELECTRICAL STIMULATION ON RISK OF FALLING IN HEMODIALYSIS PATIENTS (HD Fall Risk)

Cairo University (CU)

Status: Begins enrollment in 1 month

Conditions: Fall Risk, Fall Prevention

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07380191

CairoU physical therapy

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 estimated patients

Sex: Male

Ages: 40 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

BlazePod Training plus Lifestyle Education

Experimental group

Description:

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.

Treatment:

Device: Neuromuscular Electrical Stimulation (NMES)

Tens plus Lifestyle Education

Active Comparator group

Description:

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.

Treatment:

Device: Neuromuscular Electrical Stimulation (NMES)

Device: Device + Behavioral