NMES for Rehab After Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Control Arm Sham device |
Device: Revitive Medic Neuromuscular Stimulation Device (Sham)
Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session)
|
| Experimental: Intervention Arm Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage |
Device: Revitive Medic Neuromuscular Stimulation Device
Usage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session).
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- 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
- Barthel Index [At discharge from hospital (completion of study) - up to 28 days]
Scoring tool of independence at entry and exit of study
- Rockwood Frailty Index [At discharge from hospital (completion of study) - up to 28 days]
Frailty index scoring tool 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
- Length of stay [At discharge from hospital (completion of study) - up to 28 days]
Hospital Length of stay
- 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
- 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
- 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
- Q Frailty [At discharge from hospital (completion of study) - up to 28 days]
Frailty assessment scale at entry and exit of study
- Time taken to achieve - Sitting for >5 minutes [At discharge from hospital (completion of study) - up to 28 days]
Mobility Milestone
- 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
- Hospital Resource use [At discharge from hospital (completion of study) - up to 28 days]
Contacts with rehabilitation professionals during the using of NMES
- Incremental cost-utility ratio, comparing NMES with standard care [At discharge from hospital (completion of study) - up to 28 days]
Cost-effectiveness analysis
Eligibility Criteria
Criteria
Inclusion Criteria
-
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
Exclusion Criteria
-
Inability or unwillingness to participate in trial
-
Implanted electrical device such as Pacemaker or defibrillator.
-
Pregnant
-
Acute deep vein thrombosis
-
Previous use of NMES device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Imperial College Healthcare NHS Trust | London | United Kingdom |
Sponsors and Collaborators
- Imperial College London
Investigators
- Principal Investigator: Alun H Davies, DM DSC FRCS, Imperial College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P84082
- 281309
- 20CX6284