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| ID | Type | Description | Link |
|---|---|---|---|
| 281309 | Other Identifier | National Research Ethics Service (IRAS) | |
| 20CX6284 | Other Identifier | Institutional JRCO Assessment Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Sham Comparator | Sham device |
|
| Intervention Arm | Experimental | Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revitive Medic Neuromuscular Stimulation Device | Device | Usage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At discharge from hospital (completion of study) - up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to return to baseline mobility and independence | Time in days to return to pre-operative mobility and independence | At discharge from hospital (completion of study) - up to 28 days |
| Generic Quality of life - SF-36 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Alun H Davies, DM DSC FRCS | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36797015 | Derived | Nimura M, Lane T, Rawashdeh M, Onida S, Javed A, Sritharan G, Reese G, Hrouda D, Davies AH. Study protocol for neuromuscular stimulation for rehabilitation after general and vascular surgery: a pilot randomised clinical study. BMJ Open. 2023 Feb 16;13(2):e061800. doi: 10.1136/bmjopen-2022-061800. |
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Anonymised data will be available following publication to requesting researchers.
After publication and analysis complete.
On request from Academic Institutions
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 6, 2024 | |
| Reset | Aug 14, 2024 | |
| Release | Aug 1, 2025 | |
| Reset | Aug 19, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 6, 2024 | Aug 14, 2024 | |||
| Aug 1, 2025 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Sham and active devices are identical and will be randomly allocated
| Revitive Medic Neuromuscular Stimulation Device (Sham) | Device | Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session) |
|
Generic quality of life values at entry and exit of study utilising the Short Form 36 health profile
| 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 | 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 | 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 | At discharge from hospital (completion of study) - up to 28 days |
| Barthel Index | Scoring tool of independence at entry and exit of study | At discharge from hospital (completion of study) - up to 28 days |
| Rockwood Frailty Index | Frailty index scoring tool at entry and exit of study | 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 | At discharge from hospital (completion of study) - up to 28 days |
| Length of stay | Hospital Length of stay | 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 | 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 | 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 | At discharge from hospital (completion of study) - up to 28 days |
| Q Frailty | Frailty assessment scale at entry and exit of study | At discharge from hospital (completion of study) - up to 28 days |
| Time taken to achieve - Sitting for >5 minutes | Mobility Milestone | At discharge from hospital (completion of study) - up to 28 days |
| Standing for >1 minute | Mobility Milestone | At discharge from hospital (completion of study) - up to 28 days |
| Walking >50m | Mobility Milestone | At discharge from hospital (completion of study) - up to 28 days |
| Hospital Resource use | Contacts with rehabilitation professionals during the using of NMES | At discharge from hospital (completion of study) - up to 28 days |
| Incremental cost-utility ratio, comparing NMES with standard care | Cost-effectiveness analysis | At discharge from hospital (completion of study) - up to 28 days |
| Aug 19, 2025 |