Tanta
Tanta, Alquarbia, 31111, Egypt
Location contact
Heba Ali ABDELGHAFAR ALI, Phd
SUB_INVESTIGATOR
Sally Hafez Mohamed el said, Phd
CONTACT
0100101111315 ext. 0100101111315
NCT Number: NCT07380191
Renal nutrition Fluid control Safe physical activity Sleep hygiene, energy and managing fatigue Adherence and awareness
Trial opening soon.
Get Notified40 year–50 year
Male
Interventional
Not applicable
Tanta, Alquarbia, 31111, Egypt
Heba Ali ABDELGHAFAR ALI, Phd
SUB_INVESTIGATOR
Sally Hafez Mohamed el said, Phd
CONTACT
0100101111315 ext. 0100101111315
Application of PlazePod Device and Electrical Stimulation and comparison between them to decrease fall Risk in Hemodialysis Patients
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Baseline and after 12 weeks
Change in lower limb muscle strength measured using a hand-held dynamometer, recorded in kilograms (kg).
Time frame: Baseline and after 12 weeks
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
Change in quality of life measured using the Kidney Disease Quality of Life Short Form questionnaire (KDQOL-36), reported as total score.
Time frame: Throughout the 12-week intervention period
Participant adherence to the prescribed physical intervention and lifestyle education sessions, expressed as percentage of attended sessions.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Acronym: HD Fall Risk
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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