EFFECT OF PLAZEPOD VERSUS ELECTRICAL STIMULATION ON RISK OF FALLING IN HEMODIALYSIS PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Risk of Falling Assessed by Timed Up and Go Test (TUG)
研究概览
简要总结
Renal nutrition Fluid control Safe physical activity Sleep hygiene, energy and managing fatigue Adherence and awareness
详细描述
Application of PlazePod Device and Electrical Stimulation and comparison between them to decrease fall Risk in Hemodialysis Patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
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
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Severe neurological or orthopedic disorders affecting mobility.
- •Unstable cardiovascular conditions.
- •Cognitive impairment or sensory deficits.
- •Contraindications to neuromuscular electrical stimulation.
研究组 & 干预措施
BlazePod Training plus Lifestyle Education
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.
干预措施: Neuromuscular Electrical Stimulation (NMES) (Device)
Tens plus Lifestyle Education
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.
干预措施: Device + Behavioral (Device)
Tens plus Lifestyle Education
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.
干预措施: Neuromuscular Electrical Stimulation (NMES) (Device)
结局指标
主要结局
Risk of Falling Assessed by Timed Up and Go Test (TUG)
时间窗: 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)
时间窗: 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
时间窗: Baseline and after 12 weeks
Change in lower limb muscle strength measured using a hand-held dynamometer, recorded in kilograms (kg).
次要结局
- Physical Activity Level(Baseline and after 12 weeks)
- Kidney Disease-Related Quality of Life(Baseline and after 12 weeks)
研究者
Samia Wagdy El Said Diab
EFFECT OF PLAZEPOD VERSUS ELECTRICAL STIMULATION ON RISK OF FALLING IN HEMODIALYSIS PATIENTS
Cairo University