NMES for Rehab After Surgery

Imperial College London

Status: Completed

Conditions: Surgery; Vascular Diseases

Treatments: Device: Revitive Medic Neuromuscular Stimulation Device (Sham); Device: Revitive Medic Neuromuscular Stimulation Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04784962

P84082

281309 (Other Identifier)

20CX6284 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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103 participants in 2 patient groups

Control Arm

Sham Comparator group

Description:

Sham device

Treatment:

Device: Revitive Medic Neuromuscular Stimulation Device (Sham)

Intervention Arm

Experimental group

Description:

Standard rehabilitation care including physiotherapy + Adjunctive Neuromuscular Stimulation Device Usage

Treatment:

Device: Revitive Medic Neuromuscular Stimulation Device