Neuromuscular Stimulation for Rehabilitation After General and Vascular Surgery - a Pilot Randomised Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Safety and Acceptability of NMES as an adjunct for rehabilitation
研究概览
简要总结
A randomised pilot study assessing the acceptability and feasibility of utilising neuromuscular stimulation devices to enhance post-operative rehabilitation and recovery after general, vascular and urological surgery procedures.
详细描述
Patients undergoing inpatient rehabilitation after general, vascular or urological surgery will be invited to take part in a randomised study utilising either sham or active neuromuscular stimulation devices to enhance post-operative rehabilitation and physiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Sham and active devices are identical and will be randomly allocated
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically stable after index surgery
- •Willing and able to participate in study protocol
- •All ethnic groups, male or female above the age of 18 years
- •Baseline Rockwood Frailty Score of 3 or greater
排除标准
- •Inability or unwillingness to participate in trial
- •Implanted electrical device such as Pacemaker or defibrillator.
- •Acute deep vein thrombosis
- •Previous use of NMES device
研究组 & 干预措施
Control Arm
Sham device
干预措施: Revitive Medic Neuromuscular Stimulation Device (Sham) (Device)
Intervention Arm
Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage
干预措施: Revitive Medic Neuromuscular Stimulation Device (Device)
结局指标
主要结局
Safety and Acceptability of NMES as an adjunct for rehabilitation
时间窗: At discharge from hospital (completion of study) - up to 28 days
Qualitiative assessment of participant satisfaction and acceptance of NMES device as an adjunct to standard rehabilitation via semi-structured interview
次要结局
- Length of stay(At discharge from hospital (completion of study) - up to 28 days)
- Generic Quality of life - EQ-5D(At discharge from hospital (completion of study) - up to 28 days)
- Time to return to baseline mobility and independence(At discharge from hospital (completion of study) - up to 28 days)
- Rockwood Frailty Index(At discharge from hospital (completion of study) - up to 28 days)
- Standing for >1 minute(At discharge from hospital (completion of study) - up to 28 days)
- Walking >50m(At discharge from hospital (completion of study) - up to 28 days)
- Generic Quality of life - EQ VAS(At discharge from hospital (completion of study) - up to 28 days)
- 6 Minute Walk(At discharge from hospital (completion of study) - up to 28 days)
- Compliance with device usage(At discharge from hospital (completion of study) - up to 28 days)
- Incremental cost-utility ratio, comparing NMES with standard care(At discharge from hospital (completion of study) - up to 28 days)
- Time taken to achieve - Sitting for >5 minutes(At discharge from hospital (completion of study) - up to 28 days)
- Hospital Resource use(At discharge from hospital (completion of study) - up to 28 days)
- Generic Quality of life - SF-36(At discharge from hospital (completion of study) - up to 28 days)
- Barthel Index(At discharge from hospital (completion of study) - up to 28 days)
- Satisfaction with device(At discharge from hospital (completion of study) - up to 28 days)
- Timed Up and Go(At discharge from hospital (completion of study) - up to 28 days)
- Q Frailty(At discharge from hospital (completion of study) - up to 28 days)
- Functional Independence Measure(At discharge from hospital (completion of study) - up to 28 days)