NMES for Rehab After Surgery

NCT ID: NCT04784962

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2022-03-01

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.

Conditions

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Surgery Vascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Sham and active devices are identical and will be randomly allocated

Study Groups

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Control Arm

Sham device

Group Type SHAM_COMPARATOR

Revitive Medic Neuromuscular Stimulation Device (Sham)

Intervention Type DEVICE

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

Intervention Arm

Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage

Group Type EXPERIMENTAL

Revitive Medic Neuromuscular Stimulation Device

Intervention Type DEVICE

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

Interventions

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Revitive Medic Neuromuscular Stimulation Device

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

Intervention Type DEVICE

Revitive Medic Neuromuscular Stimulation Device (Sham)

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alun H Davies, DM DSC FRCS

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 36797015 (View on PubMed)

Other Identifiers

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281309

Identifier Type: OTHER

Identifier Source: secondary_id

20CX6284

Identifier Type: OTHER

Identifier Source: secondary_id

P84082

Identifier Type: -

Identifier Source: org_study_id

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