Fall Risk, Fall PreventionHD Fall RiskNCT07380191
EFFECT OF PLAZEPOD VERSUS ELECTRICAL STIMULATION ON RISK OF FALLING IN HEMODIALYSIS PATIENTS
A study testing Device + Behavioral and Neuromuscular Electrical Stimulation (NMES) in people with Fall Risk, Fall Prevention, run by Cairo University at 1 site in Egypt.
Trial summary
Renal nutrition Fluid control Safe physical activity Sleep hygiene, energy and managing fatigue Adherence and awareness Read more about this study
- Who is it for?
- Ages 40 to 50 years, men only
- Conditions the study is for
- Fall Risk, Fall Prevention
- What is being tested?
- Device + Behavioral and Neuromuscular Electrical Stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2026to 22 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- :
- 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.
Who cannot join
- Severe neurological or orthopedic disorders affecting mobility.
- Unstable cardiovascular conditions.
- Cognitive impairment or sensory deficits.
- Contraindications to neuromuscular electrical stimulation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Tanta
Tanta, Alquarbia, 31111
Sally Hafez Mohamed el said, Phd, 0100101111315 ext. 0100101111315, ysaly094@gmail.com
Heba Ali ABDELGHAFAR ALI, Phd
About this study
Renal nutrition Fluid control Safe physical activity Sleep hygiene, energy and managing fatigue Adherence and awareness
Read the detailed description
Application of PlazePod Device and Electrical Stimulation and comparison between them to decrease fall Risk in Hemodialysis Patients
- Conditions
- Fall Risk, Fall Prevention
- Being tested
- Device + Behavioral, Neuromuscular Electrical Stimulation (NMES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device + BehavioralDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Device + Behavioral; Device: Neuromuscular Electrical Stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Baseline and after 12 weeks
Secondary outcomes (2)
Physical Activity Level
Change in physical activity level measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), expressed in MET-minutes/week.
Measured: Baseline and after 12 weeks
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.
Measured: Baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start21 Mar 2026 (estimated)
- Primary completion22 Dec 2026 (estimated)
- Study completion22 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall Risk, Fall PreventionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samia Wagdy El Said Diab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380191
- Sponsor's protocol ID
- CairoU physical therapy
- Acronym
- HD Fall Risk
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: "At this time, we have not decided whether individual participant data will be shared. This is due to considerations of patient privacy, confidentiality, and ongoing analysis. A decision regarding data sharing will be made after study completion and in accordance with ethical guidelines."
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF PLAZEPOD VERSUS ELECTRICAL STIMULATION ON RISK OF FALLING IN HEMODIALYSIS PATIENTS
- ClinicalTrials.gov ID
- NCT07380191
- Acronym / sponsor ID
- HD Fall Risk / CairoU physical therapy
- Conditions
- Fall Risk, Fall Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Mar 2026 (estimated)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 22 Mar 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| BlazePod Training plus Lifestyle Education | Experimental | Device: Neuromuscular Electrical Stimulation (NMES)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. |
| Tens plus Lifestyle Education | Active comparator | Device: Device + Behavioral, Device: Neuromuscular Electrical Stimulation (NMES)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. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- :
- 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.
Key exclusion criteria (4 listed)
- Severe neurological or orthopedic disorders affecting mobility.
- Unstable cardiovascular conditions.
- Cognitive impairment or sensory deficits.
- Contraindications to neuromuscular electrical stimulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device + BehavioralThis 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. | Device | Tens plus Lifestyle Education |
| 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 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. | Device | BlazePod Training plus Lifestyle Education, Tens plus Lifestyle Education |
Primary outcome
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.
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.
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).
2 secondary outcomes
Physical Activity Level
Time frame: Baseline and after 12 weeks
Kidney Disease-Related Quality of Life
Time frame: Baseline and after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- This website provides scientific articles and studies related to lifestyle interventions, physical exercise, and fall risk in hemodialysis patients.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. "At this time, we have not decided whether individual participant data will be shared. This is due to considerations of patient privacy, confidentiality, and ongoing analysis. A decision regarding data sharing will be made after study completion and in accordance with ethical guidelines."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device + Behavioral and Neuromuscular Electrical Stimulation (NMES) in people with Fall Risk, Fall Prevention, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samia Wagdy El said Diab, PHD (01094762028 ext. 01094762028, Samiaahmeddiab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of Falling Assessed by Timed Up and Go Test (TUG) (time frame: Baseline and after 12 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.