NMES for Rehab After Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neuromuscular Stimulation for Rehabilitation After General and Vascular Surgery - a Pilot Randomised Clinical Study

Conditions
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Surgery, Vascular Diseases

Intervention / Treatment
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* Device: Revitive Medic Neuromuscular Stimulation Device
* Device: Revitive Medic Neuromuscular Stimulation Device (Sham)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control Arm<br>Sham device | Device: Revitive Medic Neuromuscular Stimulation Device (Sham)<br>* Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session)<br>|
| Experimental: Intervention Arm<br>Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage | Device: Revitive Medic Neuromuscular Stimulation Device<br>* Usage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation