NMES for Rehab After Surgery
- Conditions
- SurgeryVascular Diseases
- Interventions
- Device: Revitive Medic Neuromuscular Stimulation DeviceDevice: Revitive Medic Neuromuscular Stimulation Device (Sham)
- Registration Number
- NCT04784962
- Lead Sponsor
- Imperial College London
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm Revitive Medic Neuromuscular Stimulation Device Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage Control Arm Revitive Medic Neuromuscular Stimulation Device (Sham) Sham device
- Primary Outcome Measures
Name Time Method Safety and Acceptability of NMES as an adjunct for rehabilitation 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
- Secondary Outcome Measures
Name Time Method Time to return to baseline mobility and independence At discharge from hospital (completion of study) - up to 28 days Time in days to return to pre-operative mobility and independence
Rockwood Frailty Index At discharge from hospital (completion of study) - up to 28 days Frailty index scoring tool at entry and exit of study
Standing for >1 minute At discharge from hospital (completion of study) - up to 28 days Mobility Milestone
Walking >50m At discharge from hospital (completion of study) - up to 28 days Mobility Milestone
Generic Quality of life - EQ VAS At discharge from hospital (completion of study) - up to 28 days Generic quality of life values at entry and exit of study utilising the EuroQol Visual Analogue Scale
6 Minute Walk At discharge from hospital (completion of study) - up to 28 days Distance walked in 6 minutes at entry and exit of study
Compliance with device usage At discharge from hospital (completion of study) - up to 28 days User compliance with NMES device as assessed with usage diary and qualitative feedback
Incremental cost-utility ratio, comparing NMES with standard care At discharge from hospital (completion of study) - up to 28 days Cost-effectiveness analysis
Length of stay At discharge from hospital (completion of study) - up to 28 days Hospital Length of stay
Time taken to achieve - Sitting for >5 minutes At discharge from hospital (completion of study) - up to 28 days Mobility Milestone
Hospital Resource use At discharge from hospital (completion of study) - up to 28 days Contacts with rehabilitation professionals during the using of NMES
Generic Quality of life - SF-36 At discharge from hospital (completion of study) - up to 28 days Generic quality of life values at entry and exit of study utilising the Short Form 36 health profile
Barthel Index At discharge from hospital (completion of study) - up to 28 days Scoring tool of independence at entry and exit of study
Satisfaction with device At discharge from hospital (completion of study) - up to 28 days User satisfaction with NMES device assessed by qualitative feedback and assessment
Timed Up and Go At discharge from hospital (completion of study) - up to 28 days Time taken to stand and walk from sitting in a chair at entry and exit of study
Q Frailty At discharge from hospital (completion of study) - up to 28 days Frailty assessment scale at entry and exit of study
Generic Quality of life - EQ-5D At discharge from hospital (completion of study) - up to 28 days Generic quality of life values at entry and exit of study utilising the EuroQol 5 Domain (EQ-5D) Health Metric
Functional Independence Measure At discharge from hospital (completion of study) - up to 28 days Scoring tool of ability to function independently at entry and exit of study
Trial Locations
- Locations (1)
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom