NCT04784962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

February 23, 2021

Last Update Submit

August 1, 2022

Conditions

SurgeryVascular Diseases

Keywords

rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • Time to return to baseline mobility and independence

    At discharge from hospital (completion of study) - up to 28 days

  • Generic Quality of life - SF-36

    At discharge from hospital (completion of study) - up to 28 days

  • Generic Quality of life - EQ-5D

    At discharge from hospital (completion of study) - up to 28 days

  • Generic Quality of life - EQ VAS

    At discharge from hospital (completion of study) - up to 28 days

  • Functional Independence Measure

    At discharge from hospital (completion of study) - up to 28 days

  • +13 more secondary outcomes

Study Arms (2)

Control Arm

SHAM COMPARATOR

Sham device

Device: Revitive Medic Neuromuscular Stimulation Device (Sham)

Intervention Arm

EXPERIMENTAL

Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage

Device: Revitive Medic Neuromuscular Stimulation Device

Interventions

Revitive Medic Neuromuscular Stimulation DeviceDEVICE

Usage of the Revitive NMES device - 1-6 sessions daily (30 minutes per session).

Intervention Arm
Revitive Medic Neuromuscular Stimulation Device (Sham)DEVICE

Usage of the Sham Revitive NMES device - 1-6 sessions daily (30 minutes per session)

Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 36797015DERIVED

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Alun H Davies, DM DSC FRCS

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sham and active devices are identical and will be randomly allocated
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 5, 2021

Study Start

July 7, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Anonymised data will be available following publication to requesting researchers.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
After publication and analysis complete.
Access Criteria
On request from Academic Institutions

Locations

GB(1)