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NMES for Rehab After Surgery

Primary Purpose

Surgery, Vascular Diseases

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Revitive Medic Neuromuscular Stimulation Device
Revitive Medic Neuromuscular Stimulation Device (Sham)
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control Arm

Intervention Arm

Arm Description

Sham device

Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to return to baseline mobility and independence
Time in days to return to pre-operative mobility and independence
Generic Quality of life - SF-36
Generic quality of life values at entry and exit of study utilising the Short Form 36 health profile
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
Generic Quality of life - EQ VAS
Generic quality of life values at entry and exit of study utilising the EuroQol Visual Analogue Scale
Functional Independence Measure
Scoring tool of ability to function independently at entry and exit of study
Barthel Index
Scoring tool of independence at entry and exit of study
Rockwood Frailty Index
Frailty index scoring tool at entry and exit of study
Satisfaction with device
User satisfaction with NMES device assessed by qualitative feedback and assessment
Length of stay
Hospital Length of stay
6 Minute Walk
Distance walked in 6 minutes at entry and exit of study
Timed Up and Go
Time taken to stand and walk from sitting in a chair at entry and exit of study
Compliance with device usage
User compliance with NMES device as assessed with usage diary and qualitative feedback
Q Frailty
Frailty assessment scale at entry and exit of study
Time taken to achieve - Sitting for >5 minutes
Mobility Milestone
Standing for >1 minute
Mobility Milestone
Walking >50m
Mobility Milestone
Hospital Resource use
Contacts with rehabilitation professionals during the using of NMES
Incremental cost-utility ratio, comparing NMES with standard care
Cost-effectiveness analysis

Full Information

First Posted
February 23, 2021
Last Updated
August 1, 2022
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT04784962
Brief Title
NMES for Rehab After Surgery
Official Title
Neuromuscular Stimulation for Rehabilitation After General and Vascular Surgery - a Pilot Randomised Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Vascular Diseases
Keywords
rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Sham and active devices are identical and will be randomly allocated
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Sham Comparator
Arm Description
Sham device
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage
Intervention Type
Device
Intervention Name(s)
Revitive Medic Neuromuscular Stimulation Device
Intervention Description
Usage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session).
Intervention Type
Device
Intervention Name(s)
Revitive Medic Neuromuscular Stimulation Device (Sham)
Intervention Description
Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session)
Primary Outcome Measure Information:
Title
Safety and Acceptability of NMES as an adjunct for rehabilitation
Description
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
Secondary Outcome Measure Information:
Title
Time to return to baseline mobility and independence
Description
Time in days to return to pre-operative mobility and independence
Time Frame
At discharge from hospital (completion of study) - up to 28 days
Title
Generic Quality of life - SF-36
Description
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
Title
Generic Quality of life - EQ-5D
Description
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
Title
Generic Quality of life - EQ VAS
Description
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
Title
Functional Independence Measure
Description
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
Title
Barthel Index
Description
Scoring tool of independence at entry and exit of study
Time Frame
At discharge from hospital (completion of study) - up to 28 days
Title
Rockwood Frailty Index
Description
Frailty index scoring tool at entry and exit of study
Time Frame
At discharge from hospital (completion of study) - up to 28 days
Title
Satisfaction with device
Description
User satisfaction with NMES device assessed by qualitative feedback and assessment
Time Frame
At discharge from hospital (completion of study) - up to 28 days
Title
Length of stay
Description
Hospital Length of stay
Time Frame
At discharge from hospital (completion of study) - up to 28 days
Title
6 Minute Walk
Description
Distance walked in 6 minutes at entry and exit of study
Time Frame
At discharge from hospital (completion of study) - up to 28 days
Title
Timed Up and Go
Description
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
Title
Compliance with device usage
Description
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
Title
Q Frailty
Description
Frailty assessment scale at entry and exit of study
Time Frame
At discharge from hospital (completion of study) - up to 28 days
Title
Time taken to achieve - Sitting for >5 minutes
Description
Mobility Milestone
Time Frame
At discharge from hospital (completion of study) - up to 28 days
Title
Standing for >1 minute
Description
Mobility Milestone
Time Frame
At discharge from hospital (completion of study) - up to 28 days
Title
Walking >50m
Description
Mobility Milestone
Time Frame
At discharge from hospital (completion of study) - up to 28 days
Title
Hospital Resource use
Description
Contacts with rehabilitation professionals during the using of NMES
Time Frame
At discharge from hospital (completion of study) - up to 28 days
Title
Incremental cost-utility ratio, comparing NMES with standard care
Description
Cost-effectiveness analysis
Time Frame
At discharge from hospital (completion of study) - up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alun H Davies, DM DSC FRCS
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised data will be available following publication to requesting researchers.
IPD Sharing Time Frame
After publication and analysis complete.
IPD Sharing Access Criteria
On request from Academic Institutions

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NMES for Rehab After Surgery

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