NMES for Rehab After Surgery

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: Completed
• Conditions: Vascular Diseases; Surgery
• Intervention / Treatment: Device: Revitive Medic Neuromuscular Stimulation Device (Sham); Device: Revitive Medic Neuromuscular Stimulation Device

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: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Alun H Davies, DM DSC FRCS, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID 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