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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
103
Usage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session).
Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session)
Imperial College Healthcare NHS Trust
London, United Kingdom
Safety and Acceptability of NMES as an adjunct for rehabilitation
Qualitiative assessment of participant satisfaction and acceptance of NMES device as an adjunct to standard rehabilitation via semi-structured interview
Time frame: At discharge from hospital (completion of study) - up to 28 days
Time to return to baseline mobility and independence
Time in days to return to pre-operative mobility and independence
Time frame: At discharge from hospital (completion of study) - up to 28 days
Generic Quality of life - SF-36
Generic quality of life values at entry and exit of study utilising the Short Form 36 health profile
Time frame: At discharge from hospital (completion of study) - up to 28 days
Generic Quality of life - EQ-5D
Generic quality of life values at entry and exit of study utilising the EuroQol 5 Domain (EQ-5D) Health Metric
Time frame: At discharge from hospital (completion of study) - up to 28 days
Generic Quality of life - EQ VAS
Generic quality of life values at entry and exit of study utilising the EuroQol Visual Analogue Scale
Time frame: At discharge from hospital (completion of study) - up to 28 days
Functional Independence Measure
Scoring tool of ability to function independently at entry and exit of study
Time frame: At discharge from hospital (completion of study) - up to 28 days
Barthel Index
Scoring tool of independence at entry and exit of study
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Time frame: At discharge from hospital (completion of study) - up to 28 days
Rockwood Frailty Index
Frailty index scoring tool at entry and exit of study
Time frame: At discharge from hospital (completion of study) - up to 28 days
Satisfaction with device
User satisfaction with NMES device assessed by qualitative feedback and assessment
Time frame: At discharge from hospital (completion of study) - up to 28 days
Length of stay
Hospital Length of stay
Time frame: At discharge from hospital (completion of study) - up to 28 days
6 Minute Walk
Distance walked in 6 minutes at entry and exit of study
Time frame: At discharge from hospital (completion of study) - up to 28 days
Timed Up and Go
Time taken to stand and walk from sitting in a chair at entry and exit of study
Time frame: At discharge from hospital (completion of study) - up to 28 days
Compliance with device usage
User compliance with NMES device as assessed with usage diary and qualitative feedback
Time frame: At discharge from hospital (completion of study) - up to 28 days
Q Frailty
Frailty assessment scale at entry and exit of study
Time frame: At discharge from hospital (completion of study) - up to 28 days
Time taken to achieve - Sitting for >5 minutes
Mobility Milestone
Time frame: At discharge from hospital (completion of study) - up to 28 days
Standing for >1 minute
Mobility Milestone
Time frame: At discharge from hospital (completion of study) - up to 28 days
Walking >50m
Mobility Milestone
Time frame: At discharge from hospital (completion of study) - up to 28 days
Hospital Resource use
Contacts with rehabilitation professionals during the using of NMES
Time frame: At discharge from hospital (completion of study) - up to 28 days
Incremental cost-utility ratio, comparing NMES with standard care
Cost-effectiveness analysis
Time frame: At discharge from hospital (completion of study) - up to 28 days