The Use of NMES as a Home-based Therapy Following Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lower limb venous hemodynamics using Doppler ultrasound
研究概览
简要总结
The use of neuromuscular electrical stimulation (NMES) as a home-based therapy following total knee arthroplasty. Measures of interest: lower limb venous hemodynamics, joint range of motion, lower limb swelling, walking speed, quality of life, activities of daily living, device usability, device compliance, activity levels, and pain (VAS).
详细描述
The use of neuromuscular electrical stimulation (NMES) as a home-based therapy following total knee arthroplasty. All participants receive and use a research stimulator for approximately 5 weeks following total knee arthroplasty. Participants randomised to either a stimulation group or placebo-controlled group. Stimulation of the soleus muscle to investigate the effects on lower limb venous hemodynamics, joint range of motion, lower limb swelling, walking speed, quality of life, activities of daily living, device usability, device compliance, activity levels, and pain (VAS) in both groups.
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)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient undergoing knee arthroplasty in the Galway Clinic with an ability to understand the nature of the study
- •Ability to give informed consent
- •Not excluded based on exclusion criteria
排除标准
- •history of symptomatic heart disease or severe arterial disease
- •pregnancy
- •presence of a pacemaker
- •history of neurological disorder
- •presence of cognitive difficulties which may prevent the patient or his/her carer from using the stimulator properly
结局指标
主要结局
Lower limb venous hemodynamics using Doppler ultrasound
时间窗: Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation
Venous hemodynamics using Doppler ultrasound
次要结局
- Joint range of motion Knee and ankle range of motion using a goniometer(Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation)
- Lower limb swelling Circumference measures and volume calculations(Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation)
- Pain (associated with stimulation) on a visual analogue scale(Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation)
- Activity levels ActivPAL activity monitor(Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation)
- Activities of daily living Lawton, Katz, Barthel scales(One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation)
- Quality of life QoL scales- Knee injury and Osteoarthritis Outcome Score (KOOS)(One week (on average) pre-operation, 3 weeks post-operation and 6 weeks post-operation)
- Compliance with use of the custom-built research muscle stimulator(Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation)
- Device usability System Usability Scale (SUS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) scales(6 weeks post-operation)
- Walking speed 10 metre walk test(Participants will be followed from baseline (on average one week pre-operation) up to 6 weeks post-operation)
研究者
Gearoid O Laighin
Professor
National University of Ireland, Galway, Ireland