NMES for Rehab After Surgery

August 1, 2022 updated by: Imperial College London

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and Acceptability of NMES as an adjunct for rehabilitation
Time Frame: 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
At discharge from hospital (completion of study) - up to 28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to return to baseline mobility and independence
Time Frame: At discharge from hospital (completion of study) - up to 28 days
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
Time Frame: 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
At discharge from hospital (completion of study) - up to 28 days
Generic Quality of life - EQ-5D
Time Frame: 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
At discharge from hospital (completion of study) - up to 28 days
Generic Quality of life - EQ VAS
Time Frame: 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
At discharge from hospital (completion of study) - up to 28 days
Functional Independence Measure
Time Frame: At discharge from hospital (completion of study) - up to 28 days
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
Time Frame: At discharge from hospital (completion of study) - up to 28 days
Scoring tool of independence at entry and exit of study
At discharge from hospital (completion of study) - up to 28 days
Rockwood Frailty Index
Time Frame: At discharge from hospital (completion of study) - up to 28 days
Frailty index scoring tool at entry and exit of study
At discharge from hospital (completion of study) - up to 28 days
Satisfaction with device
Time Frame: At discharge from hospital (completion of study) - up to 28 days
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
Time Frame: At discharge from hospital (completion of study) - up to 28 days
Hospital Length of stay
At discharge from hospital (completion of study) - up to 28 days
6 Minute Walk
Time Frame: At discharge from hospital (completion of study) - up to 28 days
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 Frame: 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
At discharge from hospital (completion of study) - up to 28 days
Compliance with device usage
Time Frame: At discharge from hospital (completion of study) - up to 28 days
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
Time Frame: At discharge from hospital (completion of study) - up to 28 days
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
Time Frame: At discharge from hospital (completion of study) - up to 28 days
Mobility Milestone
At discharge from hospital (completion of study) - up to 28 days
Standing for >1 minute
Time Frame: At discharge from hospital (completion of study) - up to 28 days
Mobility Milestone
At discharge from hospital (completion of study) - up to 28 days
Walking >50m
Time Frame: At discharge from hospital (completion of study) - up to 28 days
Mobility Milestone
At discharge from hospital (completion of study) - up to 28 days
Hospital Resource use
Time Frame: At discharge from hospital (completion of study) - up to 28 days
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
Time Frame: At discharge from hospital (completion of study) - up to 28 days
Cost-effectiveness analysis
At discharge from hospital (completion of study) - up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alun H Davies, DM DSC FRCS, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P84082
  • 281309 (Other Identifier: National Research Ethics Service (IRAS))
  • 20CX6284 (Other Identifier: Institutional JRCO Assessment Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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